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Testing av tillegget av anti-kreftmedisinen Venetoclax og/eller anti-kreft immunterapien Blinatumomab til den vanlige kjemoterapibehandlingen for spedbarn med nylig diagnostisert KMT2A-omorganisert eller KMT2A-ikke-omorganisert leukemi

24. oktober 2026 oppdatert av: National Cancer Institute (NCI)

En fase 2-studie av blinatumomab i kombinasjon med kjemoterapi for spedbarn med nylig diagnostisert akutt lymfoblastisk leukemi med randomisering av KMT2A-omorganiserte pasienter til tillegg av Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of venetoclax in addition to a standard chemotherapy backbone and two cycles of blinatumomab in infants (aged 365 days or less at diagnosis) with newly diagnosed KMT2A-R ALL.

II. To determine in a randomized manner if the addition of venetoclax to induction chemotherapy improves end of induction minimal residual disease (MRD)-negative remission rates in infants with KMT2A-R ALL.

SECONDARY OBJECTIVES:

I. To estimate the MRD-negative remission rate for all eligible infants with KMT2A-R ALL treated with venetoclax at the recommended phase 2 dose (RP2D).

II. To compare event free survival (EFS) rates of infants with KMT2A-R ALL treated on arm B to those treated on arm A.

III. To compare 3-year EFS rates of infants with KMT2A-R ALL treated on arm A to historical controls.

IV. To determine the feasibility of treating infants with KMT2A-G ALL with a Children's Oncology Group (COG) high risk ALL chemotherapy backbone and two cycles of blinatumomab and estimate the 3-year EFS rate of infants with KMT2A-G ALL treated on arm C.

V. To characterize the pharmacokinetics (PK) of venetoclax in infants.

EXPLORATORY OBJECTIVES:

I. To describe 3-year EFS rate of infants with KMT2A-R ALL treated on arm B. II. To evaluate the use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry.

III. To characterize the PK of calaspargase pegol in infants with ALL. IV. To report the incidence of CD19 negative relapse and myeloid switch relapse with protocol therapy.

V. To evaluate the impact of venetoclax in combination with chemotherapy on T-cell subsets and function.

VI. To describe the feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor (CAR) T- cell therapy after coming off protocol therapy.

VII. To determine predictors of response and resistance to venetoclax and overall protocol therapy.

VIII. To evaluate the impact of subsequent anti-cancer therapy on overall survival after coming off protocol therapy.

IX. To compare overall survival (OS) rates of infants by arms and to historical OS rates.

OUTLINE:

STEROID PREPHASE: All patients receive prednisone or prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) or methylprednisolone intravenously (IV) TID for 7 days prior to the start of induction therapy (on days 1-7).

Patients who are KMT2A gene rearrangement positive are assigned to the safety phase cohort during the safety phase of the study, or randomized between Arm A and Arm B during the expansion phase of the study. Patients who are KMT2A gene rearrangement negative are assigned to Arm C.

SAFETY PHASE COHORT (CLOSED TO ACCRUAL 06/03/2026):

INDUCTION: Patients receive venetoclax PO or NG once daily (QD) on days 1-7, 1-10, or 1-14, daunorubicin IV over 1-15 minutes on days 1 and 2, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy (methotrexate, hydrocortisone, cytarabine) intrathecally (IT) on days 1, 15, and 29 or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when absolute neutrophil counts (ANC) >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and intrathecal therapy IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-central nervous system (CNS) extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine subcutaneously (SC) QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, and intrathecal therapy IT on day 29. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to MARMA the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MARMA: Patients receive mercaptopurine PO or NG QD on days 1-14, high dose methotrexate IV over 24 hours on days 1 and 8, leucovorin PO, NG, or IV or levoleucovorin IV on days 3-4 and 10-11, intrathecal therapy IT on days 1 and 8, high dose cytarabine IV over 3 hours on days 22-23 and 29-30, and recombinant crisantaspase IM on days 23 and 30. At the end of MARMA (day 49), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28 and intrathecal therapy IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive calaspargase pegol IV over 1-2 hours on day 1, dexamethasone PO, NG, or IV TID on days 1-21, thioguanine PO or NG on days 1-28 and 36-49, vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine SC or IV over 1-30 minutes on days 2-5, 9-12, 16-19, 23-26, 37-40, and 44-47, cyclophosphamide IV over 15-30 minutes on days 36 and 50, and intrathecal therapy IT on days 1 and 15. At the end of delayed intensification (day 63), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

MAINTENANCE: Patients receive mercaptopurine PO or NG on days 1-84 of each cycle, methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle, and intrathecal therapy IT on day 1 of cycles 1-3. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity.

EXPANSION PHASE: After completion of Safety phase, patients who are KMT2A gene rearrangement positive are randomized to Arm A or Arm B.

ARM A:

INDUCTION: Patients receive daunorubicin IV over 1-15 minutes on days 1 and 2, cytarabine SC or IV over 1-30 minutes on days 1-14, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy IT on days 1, 15, and 29, or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when ANC >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and intrathecal therapy IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-CNS extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine SC QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, and intrathecal therapy IT on day 29. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to MARMA the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MARMA: Patients receive mercaptopurine PO or NG QD on days 1-14, high dose methotrexate IV over 24 hours on days 1 and 8, leucovorin PO, NG, or IV or levoleucovorin IV on days 3-4 and 10-11, intrathecal therapy IT on days 1 and 8, high dose cytarabine IV over 3 hours on days 22-23 and 29-30, and recombinant crisantaspase IM on days 23 and 30. At the end of MARMA (day 49), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28 and intrathecal therapy IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive calaspargase pegol IV over 1-2 hours on day 1, dexamethasone PO, NG, or IV TID on days 1-21, thioguanine PO or NG on days 1-28 and 36-49, vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine SC or IV over 1-30 minutes on days 2-5, 9-12, 16-19, 23-26, 37-40, and 44-47, cyclophosphamide IV over 15-30 minutes on days 36 and 50, and intrathecal therapy IT on days 1 and 15. At the end of delayed intensification (day 63), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

MAINTENANCE: Patients receive mercaptopurine PO or NG on days 1-84 of each cycle, methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle, and intrathecal therapy IT on day 1 of cycles 1-3. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity.

ARM B: Patients are assigned to 1 of 4 cohorts.

COHORT 1:

INDUCTION + VENETOCLAX: Patients receive venetoclax PO or NG QD on days 1-14, daunorubicin IV over 1-15 minutes on days 1 and 2, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy IT on days 1, 15, and 29 or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when ANC >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and intrathecal therapy IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-CNS extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine SC QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, and intrathecal therapy IT on day 29. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to MARMA the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MARMA + VENETOCLAX: Patients receive mercaptopurine PO or NG QD on days 1-14, high dose methotrexate IV over 24 hours on days 1 and 8, leucovorin PO, NG, or IV or levoleucovorin IV on days 3-4 and 10-11, intrathecal therapy IT on days 1 and 8, venetoclax PO or NG QD on days 22-35, high dose cytarabine IV over 3 hours on days 22-23 and 29-30, and recombinant crisantaspase IM on days 23 and 30. At the end of MARMA (day 49), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28 and intrathecal therapy IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive calaspargase pegol IV over 1-2 hours on day 1, dexamethasone PO, NG, or IV TID on days 1-21, thioguanine PO or NG on days 1-28 and 36-49, vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine SC or IV over 1-30 minutes on days 2-5, 9-12, 16-19, 23-26, 37-40, and 44-47, cyclophosphamide IV over 15-30 minutes on days 36 and 50, and intrathecal therapy IT on days 1 and 15. At the end of delayed intensification (day 63), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

MAINTENANCE: Patients receive mercaptopurine PO or NG on days 1-84 of each cycle, methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle, and intrathecal therapy IT on day 1 of cycles 1-3. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity.

COHORT 2:

INDUCTION + VENETOCLAX: Patients receive venetoclax PO or NG QD on days 1-14, daunorubicin IV over 1-15 minutes on days 1 and 2, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy IT on days 1, 15, and 29 or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when ANC >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and intrathecal therapy IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-CNS extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

CONSOLIDATION + VENETOCLAX: Patients receive venetoclax PO or NG QD on days 1-14 and 29-42, cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine SC QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, and intrathecal therapy IT on day 29. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to MARMA the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MARMA: Patients receive mercaptopurine PO or NG QD on days 1-14, high dose methotrexate IV over 24 hours on days 1 and 8, leucovorin PO, NG, or IV or levoleucovorin IV on days 3-4 and 10-11, intrathecal therapy IT on days 1 and 8, high dose cytarabine IV over 3 hours on days 22-23 and 29-30, and recombinant crisantaspase IM on days 23 and 30. At the end of MARMA (day 49), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28 and intrathecal therapy IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive calaspargase pegol IV over 1-2 hours on day 1, dexamethasone PO, NG, or IV TID on days 1-21, thioguanine PO or NG on days 1-28 and 36-49, vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine SC or IV over 1-30 minutes on days 2-5, 9-12, 16-19, 23-26, 37-40, and 44-47, cyclophosphamide IV over 15-30 minutes on days 36 and 50, and intrathecal therapy IT on days 1 and 15. At the end of delayed intensification (day 63), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

MAINTENANCE: Patients receive mercaptopurine PO or NG on days 1-84 of each cycle, methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle, and intrathecal therapy IT on day 1 of cycles 1-3. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity.

COHORT 3:

INDUCTION + VENETOCLAX: Patients receive venetoclax PO or NG QD on days 1-14, daunorubicin IV over 1-15 minutes on days 1 and 2, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy IT on days 1, 15, and 29 or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when ANC >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and intrathecal therapy IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-CNS extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

CONSOLIDATION + VENETOCLAX: Patients receive venetoclax PO or NG QD on days 1-14 and 29-42, cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine SC QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, and intrathecal therapy IT on day 29. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to MARMA the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MARMA + VENETOCLAX: Patients receive mercaptopurine PO or NG QD on days 1-14, high dose methotrexate IV over 24 hours on days 1 and 8, leucovorin PO, NG, or IV or levoleucovorin IV on days 3-4 and 10-11, intrathecal therapy IT on days 1 and 8, venetoclax PO or NG QD on days 22-35, high dose cytarabine IV over 3 hours on days 22-23 and 29-30, and recombinant crisantaspase IM on days 23 and 30. At the end of MARMA (day 49), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28 and intrathecal therapy IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive calaspargase pegol IV over 1-2 hours on day 1, dexamethasone PO, NG, or IV TID on days 1-21, thioguanine PO or NG on days 1-28 and 36-49, vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine SC or IV over 1-30 minutes on days 2-5, 9-12, 16-19, 23-26, 37-40, and 44-47, cyclophosphamide IV over 15-30 minutes on days 36 and 50, and intrathecal therapy IT on days 1 and 15. At the end of delayed intensification (day 63), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

MAINTENANCE: Patients receive mercaptopurine PO or NG on days 1-84 of each cycle, methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle, and intrathecal therapy IT on day 1 of cycles 1-3. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity.

COHORT 4:

INDUCTION + VENETOCLAX: Patients receive venetoclax PO or NG QD on days 1-14, daunorubicin IV over 1-15 minutes on days 1 and 2, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy IT on days 1, 15, and 29 or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when ANC >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and intrathecal therapy IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-CNS extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine SC QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, and intrathecal therapy IT on day 29. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to MARMA the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MARMA: Patients receive mercaptopurine PO or NG QD on days 1-14, high dose methotrexate IV over 24 hours on days 1 and 8, leucovorin PO, NG, or IV or levoleucovorin IV on days 3-4 and 10-11, intrathecal therapy IT on days 1 and 8, high dose cytarabine IV over 3 hours on days 22-23 and 29-30, and recombinant crisantaspase IM on days 23 and 30. At the end of MARMA (day 49), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28 and intrathecal therapy IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive calaspargase pegol IV over 1-2 hours on day 1, dexamethasone PO, NG, or IV TID on days 1-21, thioguanine PO or NG on days 1-28 and 36-49, vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes on days 1, 8, 15, and 22, cytarabine SC or IV over 1-30 minutes on days 2-5, 9-12, 16-19, 23-26, 37-40, and 44-47, cyclophosphamide IV over 15-30 minutes on days 36 and 50, and intrathecal therapy IT on days 1 and 15. At the end of delayed intensification (day 63), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

MAINTENANCE: Patients receive mercaptopurine PO or NG on days 1-84 of each cycle, methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle, and intrathecal therapy IT on day 1 of cycles 1-3. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity.

ARM C:

INDUCTION: Patients receive daunorubicin IV over 1-15 minutes on days 1 and 2, cytarabine SC or IV over 1-30 minutes on days 1-14, vincristine IV on days 1, 8, 15, and 22, dexamethasone PO, NG, or IV TID on days 1-28, calaspargase pegol IV over 1-2 hours on day 4, and intrathecal therapy IT on days 1, 15, and 29, or days 1, 8, 15, 22, and 29. Patients with < 5% blasts by morphology in the bone marrow at the end of induction (day 35) proceed directly to blinatumomab block 1 on the next day or when ANC >= 500/uL and platelets >= 50,000/uL. Patients with >= 5% blasts by morphology in the bone marrow at the end of induction proceed to blinatumomab block 1 as soon as marrow results are known, irrespective of ANC or platelet values.

BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO, NG, or IV on day 1 or days 1 and 8, blinatumomab IV on days 1-28, 1-7, or 8-28, and methotrexate IT on days 15 and 29. Patients who are MRD >= 1% or who have residual non-CNS extramedullary disease at the end of blinatumomab block 1 (day 35) discontinue protocol therapy. All other patients proceed directly to consolidation on the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine SC QD or IV over 1-30 minutes on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO or NG QD on days 1-14 and 29-42, methotrexate IT on days 8, 15, and 22, vincristine IV on days 15, 22, 43, and 50, and calaspargase pegol IV over 1-2 hours on days 15 and 43. Patients who are MRD >= 0.01% at the end of consolidation therapy (day 56) discontinue protocol therapy. All other patients proceed directly to interim maintenance 1 the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

INTERIM MAINTENANCE 1: Patients receive vincristine IV on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, mercaptopurine PO or NG on days 1-14, 15-28, 29-42, and 43-56, methotrexate IT on days 1 and 29, and leucovorin PO or NG or IV or levoleucovorin IV on days 3-4, 17-18, 31-32, and 45-46. At the end of interim maintenance 1 (day 63), all patients proceed directly to blinatumomab block 2 the next day or when peripheral counts recover to ANC >= 500/uL and platelets >= 50,000/uL.

BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV on days 1-28, and methotrexate IT on days 1 and 15. At the end of blinatumomab block 2 (day 35), all patients proceed directly to delayed intensification the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

DELAYED INTENSIFICATION: Patients receive methotrexate IT on days 1, 29, and 36, dexamethasone PO, NG, or IV BID on days 1-7 and 15-21, vincristine IV on days 1, 8, 15, 43, and 50, doxorubicin IV over 3-15 minutes on days 1, 8, and 15, calaspargase pegol IV over 1-2 hours on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO or NG on days 29-42, and cytarabine SC or IV over 1-30 minutes on days 29-32 and 36-39. At the end of delayed intensification (day 63), all patients proceed directly to interim maintenance 2 the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

INTERIM MAINTENANCE 2: Patients receive vincristine IV on days 1, 11, 21, 31, and 41, methotrexate IV push over 2-5 minutes or IV over 10-15 minutes on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and calaspargase pegol IV over 1-2 hours on days 2 and 23. At the end of interim maintenance 2 (day 56), all patients proceed directly to maintenance the next day or when peripheral counts recover to ANC >= 750/uL and platelets >= 75,000/uL.

MAINTENANCE: Patients receive methotrexate IT on day 1 of cycles 1-3, vincristine IV on day 1 of each cycle, prednisone or prednisolone PO or NG BID or methylprednisolone IV BID on days 1-5 of each cycle, mercaptopurine PO or NG on days 1-84 of each cycle, and methotrexate PO, NG, or IV on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 of each cycle. Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of interim maintenance 1 in the absence of disease progression or unacceptable toxicity.

All patients undergo bone marrow aspiration, collection of blood samples and echocardiography (ECHO) or multigated acquisition scan (MUGA) throughout the trial. Patients may undergo computed tomography (CT), magnetic resonance imaging (MRI), fludeoxyglucose-positron emission tomography (FDG-PET), and/or lumbar puncture if clinically indicated.

After completion of study treatment, patients are followed up for up to 3 years.

Studietype

Intervensjonell

Registrering (Antatt)

153

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Rekruttering
        • Children's Hospital of Alabama
        • Ta kontakt med:
        • Hovedetterforsker:
          • Matthew A. Kutny
    • Alaska
      • Anchorage, Alaska, Forente stater, 99508
    • Arizona
      • Mesa, Arizona, Forente stater, 85202
        • Rekruttering
        • Banner Children's at Desert
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 480-412-3100
        • Hovedetterforsker:
          • Joseph C. Torkildson
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72202-3591
        • Rekruttering
        • Arkansas Children's Hospital
        • Hovedetterforsker:
          • Michael W. Bishop
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 501-364-7373
    • California
      • Loma Linda, California, Forente stater, 92354
        • Rekruttering
        • Loma Linda University Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 909-558-4050
        • Hovedetterforsker:
          • Albert Kheradpour
      • Long Beach, California, Forente stater, 90806
        • Rekruttering
        • Miller Children's and Women's Hospital Long Beach
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 562-933-5600
        • Hovedetterforsker:
          • Jacqueline N. Casillas
      • Oakland, California, Forente stater, 94611
        • Rekruttering
        • Kaiser Permanente-Oakland
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 877-642-4691
          • E-post: Kpoct@kp.org
        • Hovedetterforsker:
          • Aarati V. Rao
      • Oakland, California, Forente stater, 94609
        • Rekruttering
        • UCSF Benioff Children's Hospital Oakland
        • Hovedetterforsker:
          • Anya Levinson
        • Ta kontakt med:
      • Orange, California, Forente stater, 92868
        • Rekruttering
        • Children's Hospital of Orange County
        • Ta kontakt med:
        • Hovedetterforsker:
          • Elyssa M. Rubin
      • Sacramento, California, Forente stater, 95817
        • Rekruttering
        • University of California Davis Comprehensive Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 916-734-3089
        • Hovedetterforsker:
          • Marcio H. Malogolowkin
      • San Francisco, California, Forente stater, 94158
        • Rekruttering
        • UCSF Medical Center-Mission Bay
        • Hovedetterforsker:
          • Anya Levinson
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • Children's Hospital Colorado
        • Hovedetterforsker:
          • Kelly E. Faulk
        • Ta kontakt med:
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06106
        • Rekruttering
        • Connecticut Children's Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 860-545-9981
        • Hovedetterforsker:
          • Michael S. Isakoff
      • New Haven, Connecticut, Forente stater, 06520
        • Rekruttering
        • Yale University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Farzana Pashankar
    • Delaware
      • Wilmington, Delaware, Forente stater, 19803
        • Rekruttering
        • Alfred I duPont Hospital for Children
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emi H. Caywood
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • Rekruttering
        • Children's National Medical Center
        • Hovedetterforsker:
          • Jeffrey S. Dome
        • Ta kontakt med:
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • Rekruttering
        • UF Health Cancer Institute - Gainesville
        • Hovedetterforsker:
          • Brian Stover
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 352-273-8010
      • Hollywood, Florida, Forente stater, 33021
        • Rekruttering
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 954-265-1847
          • E-post: OHR@mhs.net
        • Hovedetterforsker:
          • Iftikhar Hanif
      • Jacksonville, Florida, Forente stater, 32207
        • Rekruttering
        • Nemours Children's Clinic-Jacksonville
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emi H. Caywood
      • Miami, Florida, Forente stater, 33136
        • Rekruttering
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Hovedetterforsker:
          • Julio C. Barredo
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Arnold Palmer Hospital for Children
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zhongbo Hu
      • Orlando, Florida, Forente stater, 32827
        • Rekruttering
        • Nemours Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emi H. Caywood
      • Orlando, Florida, Forente stater, 32803
        • Rekruttering
        • AdventHealth Orlando
        • Ta kontakt med:
        • Hovedetterforsker:
          • Fouad M. Hajjar
      • Pensacola, Florida, Forente stater, 32504
      • St. Petersburg, Florida, Forente stater, 33701
        • Rekruttering
        • Johns Hopkins All Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jennifer B. Dean
      • Tampa, Florida, Forente stater, 33607
        • Rekruttering
        • Saint Joseph's Hospital/Children's Hospital-Tampa
        • Ta kontakt med:
        • Hovedetterforsker:
          • Don E. Eslin
      • West Palm Beach, Florida, Forente stater, 33407
        • Rekruttering
        • Saint Mary's Medical Center
        • Hovedetterforsker:
          • Matthew D. Ramirez
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 561-822-4745
    • Georgia
      • Atlanta, Georgia, Forente stater, 30329
        • Rekruttering
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Hovedetterforsker:
          • Melinda G. Pauly
        • Ta kontakt med:
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96826
        • Rekruttering
        • Kapiolani Medical Center for Women and Children
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 808-983-6090
        • Hovedetterforsker:
          • Wade T. Kyono
    • Idaho
      • Boise, Idaho, Forente stater, 83712
        • Rekruttering
        • Saint Luke's Cancer Institute - Boise
        • Hovedetterforsker:
          • Martha M. Pacheco
        • Ta kontakt med:
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Rekruttering
        • Lurie Children's Hospital-Chicago
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 773-880-4562
        • Hovedetterforsker:
          • Sara Zarnegar-Lumley
      • Chicago, Illinois, Forente stater, 60637
        • Rekruttering
        • University of Chicago Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gabrielle Lapping-Carr
      • Oak Lawn, Illinois, Forente stater, 60453
        • Rekruttering
        • Advocate Children's Hospital-Oak Lawn
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 847-723-7570
        • Hovedetterforsker:
          • Rebecca E. McFall
      • Park Ridge, Illinois, Forente stater, 60068
      • Peoria, Illinois, Forente stater, 61637
      • Springfield, Illinois, Forente stater, 62702
        • Rekruttering
        • Southern Illinois University School of Medicine
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 217-545-7929
        • Hovedetterforsker:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Rekruttering
        • Riley Hospital for Children
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-248-1199
        • Hovedetterforsker:
          • Amanda Saraf
      • Indianapolis, Indiana, Forente stater, 46260
        • Rekruttering
        • Ascension Saint Vincent Indianapolis Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bassem I. Razzouk
    • Iowa
      • Des Moines, Iowa, Forente stater, 50309
        • Rekruttering
        • Blank Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Samantha L. Mallory
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • Rekruttering
        • University of Kentucky/Markey Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 859-257-3379
        • Hovedetterforsker:
          • James T. Badgett
      • Louisville, Kentucky, Forente stater, 40202
        • Rekruttering
        • Norton Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael J. Ferguson
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70118
        • Rekruttering
        • Children's Hospital New Orleans
        • Hovedetterforsker:
          • Maria C. Velez-Yanguas
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 504-894-5377
      • New Orleans, Louisiana, Forente stater, 70121
        • Rekruttering
        • Ochsner Medical Center Jefferson
        • Ta kontakt med:
        • Hovedetterforsker:
          • Craig Lotterman
    • Maine
      • Scarborough, Maine, Forente stater, 04074
        • Rekruttering
        • Maine Children's Cancer Program
        • Hovedetterforsker:
          • Sei-Gyung K. Sze
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Rekruttering
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Hovedetterforsker:
          • Stacy L. Cooper
        • Ta kontakt med:
      • Baltimore, Maryland, Forente stater, 21215
        • Rekruttering
        • Sinai Hospital of Baltimore
        • Hovedetterforsker:
          • Jason M. Fixler
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 410-601-9083
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Rekruttering
        • Dana-Farber Cancer Institute
        • Hovedetterforsker:
          • Melissa A. Burns
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 877-442-3324
      • Worcester, Massachusetts, Forente stater, 01655
        • Rekruttering
        • UMass Memorial Medical Center - University Campus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Stefanie R. Lowas
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Rekruttering
        • C S Mott Children's Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-865-1125
        • Hovedetterforsker:
          • Joshua W. Goldman
      • Grand Rapids, Michigan, Forente stater, 49503
        • Rekruttering
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Forente stater, 49007
        • Rekruttering
        • Bronson Methodist Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathleen Y. Butler
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Rekruttering
        • University of Minnesota/Masonic Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 612-624-2620
        • Hovedetterforsker:
          • Peter M. Gordon
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216
        • Rekruttering
        • University of Mississippi Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 601-815-6700
        • Hovedetterforsker:
          • Amanda Strobel
    • Missouri
      • Kansas City, Missouri, Forente stater, 64108
        • Rekruttering
        • Children's Mercy Hospitals and Clinics
        • Hovedetterforsker:
          • Keith J. August
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Ta kontakt med:
        • Hovedetterforsker:
          • Laura G. Schuettpelz
      • St Louis, Missouri, Forente stater, 63141
        • Rekruttering
        • Mercy Hospital Saint Louis
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 314-251-7066
        • Hovedetterforsker:
          • Robin D. Hanson
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68114
        • Rekruttering
        • Children's Hospital and Medical Center of Omaha
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 402-955-3949
        • Hovedetterforsker:
          • Jill C. Beck
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89135
        • Rekruttering
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joseph L. Lasky
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Rekruttering
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Hovedetterforsker:
          • Angela Ricci
        • Ta kontakt med:
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Rekruttering
        • Hackensack University Medical Center
        • Hovedetterforsker:
          • Jing Chen
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 551-996-2897
      • Morristown, New Jersey, Forente stater, 07960
        • Rekruttering
        • Morristown Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 973-971-5900
        • Hovedetterforsker:
          • Kathryn L. Laurie
      • New Brunswick, New Jersey, Forente stater, 08903
        • Rekruttering
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
        • Hovedetterforsker:
          • Marissa Botwinick
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 732-235-8675
      • Paterson, New Jersey, Forente stater, 07503
        • Rekruttering
        • Saint Joseph's Regional Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alissa Kahn
    • New York
      • Albany, New York, Forente stater, 12208
        • Rekruttering
        • Albany Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 518-262-5513
        • Hovedetterforsker:
          • Lauren R. Weintraub
      • Buffalo, New York, Forente stater, 14263
        • Rekruttering
        • Roswell Park Cancer Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lisa Niswander
      • New Hyde Park, New York, Forente stater, 11040
        • Rekruttering
        • The Steven and Alexandra Cohen Children's Medical Center of New York
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 718-470-3460
        • Hovedetterforsker:
          • Julie I. Krystal
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 212-639-7592
        • Hovedetterforsker:
          • Kavitha Ramaswamy
      • New York, New York, Forente stater, 10016
        • Rekruttering
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Hovedetterforsker:
          • Elizabeth A. Raetz
        • Ta kontakt med:
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • NYP/Weill Cornell Medical Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 212-746-1848
        • Hovedetterforsker:
          • Jaclyn Rosenzweig
      • Rochester, New York, Forente stater, 14642
        • Rekruttering
        • University of Rochester
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 585-275-5830
        • Hovedetterforsker:
          • Carol Fries Simpson
      • Syracuse, New York, Forente stater, 13210
        • Rekruttering
        • State University of New York Upstate Medical University
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 315-464-5476
        • Hovedetterforsker:
          • Melanie A. Comito
      • The Bronx, New York, Forente stater, 10467
        • Rekruttering
        • Montefiore Medical Center - Moses Campus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Alice Lee
      • Valhalla, New York, Forente stater, 10595
        • Rekruttering
        • New York Medical College
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 914-594-3794
        • Hovedetterforsker:
          • Andrew J. Bellantoni
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • Rekruttering
        • UNC Lineberger Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Thomas B. Alexander
      • Charlotte, North Carolina, Forente stater, 28203
        • Rekruttering
        • Carolinas Medical Center/Levine Cancer Institute
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-804-9376
        • Hovedetterforsker:
          • Joel A. Kaplan
      • Durham, North Carolina, Forente stater, 27710
        • Rekruttering
        • Duke University Medical Center
        • Hovedetterforsker:
          • Jessica M. Sun
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 888-275-3853
      • Greenville, North Carolina, Forente stater, 27834
        • Rekruttering
        • East Carolina University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Andrea R. Whitfield
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Rekruttering
        • Wake Forest University Health Sciences
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 336-713-6771
        • Hovedetterforsker:
          • Sarah Supples
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58122
    • Ohio
      • Akron, Ohio, Forente stater, 44308
        • Rekruttering
        • Children's Hospital Medical Center of Akron
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 330-543-3193
        • Hovedetterforsker:
          • Lauren R. Draper
      • Cincinnati, Ohio, Forente stater, 45229
        • Rekruttering
        • Cincinnati Children's Hospital Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Erin H. Breese
      • Cleveland, Ohio, Forente stater, 44106
        • Rekruttering
        • Rainbow Babies and Childrens Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 216-844-5437
        • Hovedetterforsker:
          • Duncan S. Stearns
      • Dayton, Ohio, Forente stater, 45404
        • Rekruttering
        • Dayton Children's Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-228-4055
        • Hovedetterforsker:
          • Jordan M. Wright
      • Toledo, Ohio, Forente stater, 43606
        • Rekruttering
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jamie L. Dargart
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Rekruttering
        • University of Oklahoma Health Sciences Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Rene Y. McNall-Knapp
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Rekruttering
        • Lehigh Valley Hospital-Cedar Crest
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jacob A. Troutman
      • Danville, Pennsylvania, Forente stater, 17822
        • Rekruttering
        • Geisinger Medical Center
        • Hovedetterforsker:
          • Jagadeesh Ramdas
        • Ta kontakt med:
      • Hershey, Pennsylvania, Forente stater, 17033
        • Rekruttering
        • Penn State Children's Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 717-531-6012
        • Hovedetterforsker:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • Children's Hospital of Philadelphia
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kathrin M. Bernt
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Rekruttering
        • Children's Hospital of Pittsburgh of UPMC
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jenny Ruiz
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rekruttering
        • Rhode Island Hospital
        • Hovedetterforsker:
          • Bradley DeNardo
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 401-444-1488
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29203
        • Rekruttering
        • Prisma Health Richland Hospital
        • Hovedetterforsker:
          • Stuart L. Cramer
        • Ta kontakt med:
      • Greenville, South Carolina, Forente stater, 29605
        • Rekruttering
        • BI-LO Charities Children's Cancer Center
        • Hovedetterforsker:
          • Aniket Saha
        • Ta kontakt med:
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57117-5134
        • Rekruttering
        • Sanford USD Medical Center - Sioux Falls
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jordan Fritch-Hanson
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37916
        • Rekruttering
        • East Tennessee Childrens Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 865-541-8266
        • Hovedetterforsker:
          • Susan E. Spiller
      • Memphis, Tennessee, Forente stater, 38105
        • Rekruttering
        • Saint Jude Children's Research Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Matthew Rees
      • Nashville, Tennessee, Forente stater, 37232
        • Rekruttering
        • Vanderbilt University/Ingram Cancer Center
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 800-811-8480
        • Hovedetterforsker:
          • Brianna N. Smith
      • Nashville, Tennessee, Forente stater, 37203
        • Rekruttering
        • The Children's Hospital at TriStar Centennial
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 615-342-1919
        • Hovedetterforsker:
          • Clinton M. Carroll
    • Texas
      • Austin, Texas, Forente stater, 78723
        • Rekruttering
        • Dell Children's Medical Center of Central Texas
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shannon M. Cohn
      • Corpus Christi, Texas, Forente stater, 78411
        • Rekruttering
        • Driscoll Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Nkechi I. Mba
      • Dallas, Texas, Forente stater, 75390
        • Rekruttering
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Ta kontakt med:
        • Hovedetterforsker:
          • Caroline Smith
      • Dallas, Texas, Forente stater, 75230
        • Rekruttering
        • Medical City Dallas Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 972-566-5588
        • Hovedetterforsker:
          • Maurizio L. Ghisoli
      • El Paso, Texas, Forente stater, 79905
        • Rekruttering
        • El Paso Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Benjamin Carcamo
      • Fort Worth, Texas, Forente stater, 76104
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Hovedetterforsker:
          • Joanna S. Yi
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 713-798-1354
          • E-post: burton@bcm.edu
      • San Antonio, Texas, Forente stater, 78207
        • Rekruttering
        • Children's Hospital of San Antonio
        • Ta kontakt med:
        • Hovedetterforsker:
          • Julie Voeller
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • Methodist Children's Hospital of South Texas
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jose M. Esquilin
      • Temple, Texas, Forente stater, 76508
        • Rekruttering
        • Scott and White Memorial Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 254-724-5407
        • Hovedetterforsker:
          • Nicholas W. McGregor
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
      • Norfolk, Virginia, Forente stater, 23507
        • Rekruttering
        • Children's Hospital of The King's Daughters
        • Ta kontakt med:
        • Hovedetterforsker:
          • Melissa S. Mark
      • Richmond, Virginia, Forente stater, 23298
        • Rekruttering
        • VCU Massey Comprehensive Cancer Center
        • Hovedetterforsker:
          • Jordyn R. Griffin
        • Ta kontakt med:
      • Roanoke, Virginia, Forente stater, 24014
        • Rekruttering
        • Carilion Children's
        • Ta kontakt med:
        • Hovedetterforsker:
          • Erwood G. Edwards
    • Washington
      • Seattle, Washington, Forente stater, 98105
        • Rekruttering
        • Seattle Children's Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 866-987-2000
        • Hovedetterforsker:
          • Sarah E. Leary
      • Spokane, Washington, Forente stater, 99204
        • Rekruttering
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Judy L. Felgenhauer
    • Wisconsin
      • Green Bay, Wisconsin, Forente stater, 54301
        • Rekruttering
        • Saint Vincent Hospital Cancer Center Green Bay
        • Hovedetterforsker:
          • Catherine A. Long
        • Ta kontakt med:
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Rekruttering
        • Children's Hospital of Wisconsin
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zachary Graff
  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Rekruttering
        • University Pediatric Hospital
        • Ta kontakt med:
          • Site Public Contact
          • Telefonnummer: 787-474-0333
        • Hovedetterforsker:
          • Maria E. Echevarria

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 1 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321

  • Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age (cumulative prenatal and postnatal age must be > 36 weeks) at the time of enrollment

  • Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization [WHO] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage

    • Diagnostic immunophenotype: Leukemia cells must express CD19

Exclusion Criteria:

  • Patients with Down Syndrome

  • Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy

  • Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:

    • Steroid pretreatment:

      • PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
      • Inhaled and topical steroids are not considered pretreatment
      • Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred > 28 days before enrollment does not affect eligibility

    • Intrathecal cytarabine or methotrexate:

      • An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
      • Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status

    • Hydroxyurea:

      • Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility

  • All patients and/or their parents or legal guardians must sign a written informed consent

  • All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A

See Detailed Description for Arm A.
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

Andre navn:
  • JZP458
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi-rywn
  • Crisantaspase Biobetter JZP-458
  • JZP 458
  • JZP-458
  • PF743
  • RC-P JZP-458
  • Rekombinant asparaginase erwinia chrysanthemi JZP-458
  • Rekombinant Crisantaspase JZP-458
  • Rekombinant Erwinia asparaginase JZP-458
  • Rylaze
  • Asparaginase Erwinia chrysanthemi (rekombinant)-rywn
  • Asparaginase Erwinia chrysanthemi, rekombinant-rywn
  • Enrylaze
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Eksperimentell: Arm B, Cohort 1

See Detailed Description for Arm B, Cohort 1.
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

Andre navn:
  • JZP458
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi-rywn
  • Crisantaspase Biobetter JZP-458
  • JZP 458
  • JZP-458
  • PF743
  • RC-P JZP-458
  • Rekombinant asparaginase erwinia chrysanthemi JZP-458
  • Rekombinant Crisantaspase JZP-458
  • Rekombinant Erwinia asparaginase JZP-458
  • Rylaze
  • Asparaginase Erwinia chrysanthemi (rekombinant)-rywn
  • Asparaginase Erwinia chrysanthemi, rekombinant-rywn
  • Enrylaze
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Legemiddel: Venetoclax

Given PO or NG

Andre navn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Eksperimentell: Arm B, Cohort 2

See Detailed Description for Arm B, Cohort 2.
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

Andre navn:
  • JZP458
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi-rywn
  • Crisantaspase Biobetter JZP-458
  • JZP 458
  • JZP-458
  • PF743
  • RC-P JZP-458
  • Rekombinant asparaginase erwinia chrysanthemi JZP-458
  • Rekombinant Crisantaspase JZP-458
  • Rekombinant Erwinia asparaginase JZP-458
  • Rylaze
  • Asparaginase Erwinia chrysanthemi (rekombinant)-rywn
  • Asparaginase Erwinia chrysanthemi, rekombinant-rywn
  • Enrylaze
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Legemiddel: Venetoclax

Given PO or NG

Andre navn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Eksperimentell: Arm B, Cohort 3

See Detailed Description for Arm B, Cohort 3.
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

Andre navn:
  • JZP458
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi-rywn
  • Crisantaspase Biobetter JZP-458
  • JZP 458
  • JZP-458
  • PF743
  • RC-P JZP-458
  • Rekombinant asparaginase erwinia chrysanthemi JZP-458
  • Rekombinant Crisantaspase JZP-458
  • Rekombinant Erwinia asparaginase JZP-458
  • Rylaze
  • Asparaginase Erwinia chrysanthemi (rekombinant)-rywn
  • Asparaginase Erwinia chrysanthemi, rekombinant-rywn
  • Enrylaze
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Legemiddel: Venetoclax

Given PO or NG

Andre navn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Eksperimentell: Arm B, Cohort 4

See Detailed Description for Arm B, Cohort 4.
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

Andre navn:
  • JZP458
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi-rywn
  • Crisantaspase Biobetter JZP-458
  • JZP 458
  • JZP-458
  • PF743
  • RC-P JZP-458
  • Rekombinant asparaginase erwinia chrysanthemi JZP-458
  • Rekombinant Crisantaspase JZP-458
  • Rekombinant Erwinia asparaginase JZP-458
  • Rylaze
  • Asparaginase Erwinia chrysanthemi (rekombinant)-rywn
  • Asparaginase Erwinia chrysanthemi, rekombinant-rywn
  • Enrylaze
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Legemiddel: Venetoclax

Given PO or NG

Andre navn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Eksperimentell: Arm C

See Detailed Description for Arm C.
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Doxorubicin

Given IV

Andre navn:
  • Adriablastin
  • Hydroxydaunomycin
  • Hydroxyl Daunorubicin
  • Hydroxyldaunorubicin
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Legemiddel: Methylprednisolone

Given IV

Andre navn:
  • Medrol
  • Wyacort
  • Adlone
  • Caberdelta M
  • DepMedalone
  • Depo Moderin
  • Depo-Nisolone
  • Duralone
  • Emmetipi
  • Esametone
  • Firmacort
  • Medlone 21
  • Medrate
  • Medrol Veriderm
  • Medrone
  • Megastjerne
  • Meprolon
  • Methylprednisolum
  • Metilbetason løselig
  • Metrocort
  • Metypresol
  • Metysolon
  • Predni-M-Tablinen
  • Prednilen
  • Radilem
  • Sieropresol
  • Solpredone
  • Summicort
  • Urbason
  • Veriderm Medrol
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Legemiddel: Prednisolone

Given PO or NG

Andre navn:
  • (11beta)-11,17,21-trihydroksypregna-1,4-dien-3,20-dion
  • 61-hydrokortison
  • Adnisolon
  • Aprednislon
  • Kapsoid
  • Cortalone
  • Kortisolon
  • Dacortin H
  • Dekaprednil
  • Decortin H
  • Delta(1)Hydrokortison
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrokortison
  • Deltacortril
  • Deltahydrokortison
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolon
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metakortandralon
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafkortelon
  • Prekortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednikortelon
  • Prednisolum
  • Prelone
  • Prenilon
  • Sterane
Legemiddel: Prednisone

Given PO or NG

Andre navn:
  • Deltasone
  • Orasone
  • 61-kortison
  • 1,2-dehydrokortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltakortison
  • Deltadehydrokortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metakortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Eksperimentell: Safety Phase Cohort

See Detailed Description for Safety Phase Cohort. (CLOSED TO ACCRUAL 06/03/2026)
Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Vincristine

Given IV

Andre navn:
  • VCR
  • Leurocristine
  • Vincrystine
  • LCR
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Biologisk: Blinatumomab

Given IV

Andre navn:
  • Blincyto
  • Anti-CD19 x Anti-CD3 bispesifikt monoklonalt antistoff
  • Anti-CD19/Anti-CD3 rekombinant bispesifikt monoklonalt antistoff MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Legemiddel: Daunorubicin

Given IV

Andre navn:
  • DNR
  • Rubidomycin
  • Daunomycin
  • Daunorrubicina
  • Leukaemomycin C
  • Rubomycin C
Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Legemiddel: Calaspargase Pegol

Given IV

Andre navn:
  • Asparaginase (Escherichia coli isoenzym II), konjugat med alfa-(((2,5-Diokso-1-pyrrolidinyl)oksy)karbonyl)-omega-metoksypoly(oksy-1,2-etandiyl)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-asparaginase
  • Succinimidylkarbonatmonometoksypolyetylenglykol E. coli L-asparaginase
  • Calaspargase Pegol-mknl
Legemiddel: Therapeutic Hydrocortisone

Given IT

Andre navn:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Kortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • Hydrokortison
  • Hydrokorton
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rektoid
Legemiddel: Asparaginase Erwinia chrysanthemi

Given recombinant crisantaspase IM or crisantaspase IM or IV

Andre navn:
  • JZP458
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • Asparaginase Erwinia chrysanthemi-rywn
  • Crisantaspase Biobetter JZP-458
  • JZP 458
  • JZP-458
  • PF743
  • RC-P JZP-458
  • Rekombinant asparaginase erwinia chrysanthemi JZP-458
  • Rekombinant Crisantaspase JZP-458
  • Rekombinant Erwinia asparaginase JZP-458
  • Rylaze
  • Asparaginase Erwinia chrysanthemi (rekombinant)-rywn
  • Asparaginase Erwinia chrysanthemi, rekombinant-rywn
  • Enrylaze
Legemiddel: Cytarabine

Given IT or IV

Andre navn:
  • P-Cytosin-arabinosid
  • 1-P-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-B-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1P-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-lß-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-p-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Legemiddel: Dexamethasone

Given PO or NG or IV

Andre navn:
  • Dekadron
  • Hemady
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desametason
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Deksamekortin
  • Dexameth
  • Deksametason Intensol
  • Deksametasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Heksadekadrol
  • Heksadrol
  • Lokalison-F
  • Loverine
  • Metylfluorprednisolon
  • Millicorten
  • Mymetason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
  • LenaDex
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Leucovorin

Given PO or NG or IV

Andre navn:
  • Folinsyre
Legemiddel: Levoleucovorin

Given IV

Andre navn:
  • Levofolinsyre
  • Levofolinat
  • CL-307.782
  • Elvorine, Isovorin, Levofolene, Levorin
  • Isovorin
  • L-Leucovorin
  • Khapzory
Legemiddel: Mercaptopurine

Given PO or NG

Andre navn:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-tiol
  • 6 Tiohypoksantin
  • 6 Tiopurin
  • 6-merkaptopurin
  • 6-merkaptopurinmonohydrat
  • 6-Purinethiol
  • 6-tiopurin
  • 6-tioksopurin
  • 6H-Purin-6-tion, 1,7-dihydro- (9Cl)
  • 7-merkapto-1,3,4,6-tetrazainden
  • Alti-merkaptopurin
  • Azatiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimetol
  • Purin, 6-merkapto-
  • Purin-6-tiol (8CI)
  • Purin-6-tiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Legemiddel: Methotrexate

Given IT or IV or PO or NG

Andre navn:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alfa-metopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertreksat
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Metoblastin
  • Metotreksat LPF
  • Metotreksat Metylaminopterin
  • Metotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Reumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Jylamvo
Legemiddel: Thioguanine

Given PO or NG

Andre navn:
  • 6-TG
  • 2-amino 6 MP
  • 2-amino-1,7-dihydro-6H-purin-6-tion
  • 2-amino-6-merkaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-tiol
  • 2-aminopurin-6(1H)-tion
  • 2-aminopurin-6-tiol hemihydrat
  • 2-merkapto-6-aminopurin
  • 6-amino-2-merkaptopurin
  • 6-merkapto-2-aminopurin
  • 6-merkaptoguanin
  • 6H-Purin-6-tion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Tioguanin hemihydrat
  • Tioguaninhydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Legemiddel: Venetoclax

Given PO or NG

Andre navn:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
  • ABT 199
  • GDC 0199
  • GDC0199
Eksperimentell: Steroid Prephase(prednisone, prednisolone, methylprednisolone)

All patients receive prednisone or prednisolone PO or NG TID or methylprednisolone IV TID for 7 days prior to the start of induction therapy (on days 1-7).
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Fremgangsmåte: Bone Marrow Aspiration

Undergo bone marrow aspiration

Fremgangsmåte: Lumbar Puncture

Undergo lumbar puncture

Andre navn:
  • LP
  • Spinal Tap
Legemiddel: Methylprednisolone

Given IV

Andre navn:
  • Medrol
  • Wyacort
  • Adlone
  • Caberdelta M
  • DepMedalone
  • Depo Moderin
  • Depo-Nisolone
  • Duralone
  • Emmetipi
  • Esametone
  • Firmacort
  • Medlone 21
  • Medrate
  • Medrol Veriderm
  • Medrone
  • Megastjerne
  • Meprolon
  • Methylprednisolum
  • Metilbetason løselig
  • Metrocort
  • Metypresol
  • Metysolon
  • Predni-M-Tablinen
  • Prednilen
  • Radilem
  • Sieropresol
  • Solpredone
  • Summicort
  • Urbason
  • Veriderm Medrol
Fremgangsmåte: Biospecimen Collection

Undergo collection of blood samples

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: FDG-Positron Emission Tomography

Undergo FDG-PET

Andre navn:
  • FDG
  • FDG-PET
  • FDG-PET bildebehandling
Legemiddel: Prednisolone

Given PO or NG

Andre navn:
  • (11beta)-11,17,21-trihydroksypregna-1,4-dien-3,20-dion
  • 61-hydrokortison
  • Adnisolon
  • Aprednislon
  • Kapsoid
  • Cortalone
  • Kortisolon
  • Dacortin H
  • Dekaprednil
  • Decortin H
  • Delta(1)Hydrokortison
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrokortison
  • Deltacortril
  • Deltahydrokortison
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolon
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metakortandralon
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafkortelon
  • Prekortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednikortelon
  • Prednisolum
  • Prelone
  • Prenilon
  • Sterane
Legemiddel: Prednisone

Given PO or NG

Andre navn:
  • Deltasone
  • Orasone
  • 61-kortison
  • 1,2-dehydrokortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltakortison
  • Deltadehydrokortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metakortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of dose-limiting toxicities (DLTs) (safety phase)
Tidsramme: For the duration of the induction + venetoclax cycle

For the safety phase, DLTs of the induction + venetoclax cycle of KMT2A-rearranged (R) patients will be assessed.
For the duration of the induction + venetoclax cycle
Incidence of DLTs (expansion phase)
Tidsramme: During the induction, consolidation, and MARMA cycles of Arm B

For the expansion phase, DLTs of Arm B will be assessed and monitored for the cycles that contain venetoclax (induction, consolidation, and MARMA cycles of Arm B).
During the induction, consolidation, and MARMA cycles of Arm B
Minimal residual disease (MRD)-negative remission rate
Tidsramme: At the end of induction

The end of induction MRD-negative remission rate will be compared between Arm A and Arm B. MRD negativity is defined as achievement of complete remission and MRD < 0.01% by flow cytometry. The MRD-negative remission rate at the end of induction between Arm A and Arm B will be compared using a one-sided Z test of proportions with Type I error of 0.15.
At the end of induction

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MRD-negative remission rate
Tidsramme: At the end of induction

MRD-negative remission rate at the end of induction and the standard error or 95% confidence interval will be estimated among infants with KMT2A-R acute lymphoblastic leukemia (ALL) treated with venetoclax at the RP2D. This analysis will include eligible KMT2A-R patients treated with venetoclax at the RP2D in the safety phase, as well as patients randomized to Arm B and treated with venetoclax in the expansion phase. MRD negativity is defined as < 0.01% by flow cytometry.
At the end of induction
Event free survival (EFS) rates of infants with KMT2A-R ALL
Tidsramme: From date of randomization to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years

The EFS rates from date of randomization of Arm B will be compared to Arm A. Comparison of EFS rates between Arm A and Arm B will be based on a one-sided logrank test with Type I error of 0.15. In addition, EFS rates will be estimated using the Kaplan-Meier method with Greenwood standard errors. Hazard ratios and confidence intervals will be estimated based on Cox regression models as appropriate. Cumulative incidence rates of each EFS event type (relapse, treatment failure, secondary malignant neoplasm and death) will also be estimated and presented with cumulative incidence curves and compared between arms as appropriate.
From date of randomization to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years
3-year EFS of infants with KMT2A-R ALL
Tidsramme: From date of randomization to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years

For Arm A, the 3-year EFS rate (representing a plateau rate based on the shape of EFS curves of historical data in this patient population) from the date of randomization will be compared to the stable historical 3-year EFS rate of 35% observed in AALL0631 and other international trials.
From date of randomization to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years
Proportion of KMT2A-germline (G) patients in Arm C who are able to receive all treatment cycles before maintenance
Tidsramme: Up to interim maintenance 2

The feasibility of treating KMT2A-G patients with a high-risk ALL backbone and two cycles of blinatumomab (Arm C) will be assessed. Arm C treatment will be considered feasible for KMT2A-G patients if the proportion of KMT2A-G patients in Arm C who are able to receive all treatment cycles before maintenance (i.e., up to interim maintenance 2) is more than 76.8%. The proportion of patients receiving all cycles before Maintenance will be compared to 76.8% with a one-sample exact test of proportion with Type I error of 0.15.
Up to interim maintenance 2
3-year EFS of infants with KMT2A-G ALL treated on Arm C
Tidsramme: From date of enrollment to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years

The 3-year EFS rate from date of enrollment of KMT2A-G patients in Arm C will be estimated with the Kaplan-Meier method.
From date of enrollment to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years
Pharmacokinetics (PK) of venetoclax in infants
Tidsramme: On days 7, 10, and 14 of induction

PK samples will be collected from patients enrolled in the safety phase of the study as well as from patients randomized to Arm B in the expansion phase who consent to participate, to determine the major secondary objective of characterizing the PK of venetoclax in infants. PK samples will be evaluated in batches and standard nonlinear mixed effect modeling will be used for model building and refinement of time-concentration data. After model refinement, a non-parametric bootstrap analysis will be performed reporting the 95% confidence intervals for each PK parameter.
On days 7, 10, and 14 of induction

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
3-year EFS of infants with KMT2A-R ALL treated on Arm B
Tidsramme: From date of randomization to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years

Arm B, the 3-year EFS rate from date of randomization will be estimated, and will be compared to Arm A as described in the secondary objective, and to historical 3-year EFS. Comparison to historical rate will be based on a one-sample test of proportion with one-sided Type I error of 0.15.
From date of randomization to treatment failure, first documented relapse following achievement of remission-1, occurrence of a second or secondary malignant neoplasm, or death, assessed up to 3 years
Use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry
Tidsramme: Up to 3 years

Pre-treatment HTS clonality and HTS MRD tracking results will be collected and compared to the required centralized flow cytometry-based MRD data to evaluate the feasibility and prognostic utility of HTS MRD evaluation in the infant ALL population.
Up to 3 years
PK of calaspargase pegol in infants with ALL
Tidsramme: At completion of the trial, up to 3 years

PK of calaspargase pegol will be analyzed by monitoring asparaginase activity levels. Once a PK model is developed for calaspargase pegol, standard regression analysis will be used to describe the relationship between drug exposure and asparaginase activity. Additionally, asparaginase-associated toxicities will be described for the entire study population and correlated with activity levels when possible. The result of this analysis will be an estimation of potential optimal exposure expected to yield the maximum efficacy while limiting toxicity. These analyses will be exploratory and descriptive.
At completion of the trial, up to 3 years
Incidence of CD19-negative relapse and myeloid switch relapse with protocol therapy
Tidsramme: At the time of relapse, up to 3 years

For patients who experience relapse, will collect information regarding the immunophenotype of the leukemic blasts at time of relapse. Will report on the rate of CD19 negative relapse as well as myeloid switch relapse for all patients enrolled on study. This analysis will be exploratory and descriptive.
At the time of relapse, up to 3 years
Impact of venetoclax in combination with chemotherapy on T-cell subsets and function
Tidsramme: Prior to and following the first course of venetoclax

BCL-2 inhibition is reported to alter T-cell subsets, including increased activation, enhanced cytotoxicity against leukemia cells and heightened resistance to cell death. Peripheral blood and bone marrow samples will be collected prior to and following the first course of venetoclax to evaluate effects on T-cell subsets and function following venetoclax exposure.
Prior to and following the first course of venetoclax
Feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor (CAR) T-cell therapy
Tidsramme: After coming off protocol therapy

For patients that undergo T-cell collection, will collect data regarding the feasibility of T-cell collection in the context of protocol therapy. Additionally, for patients who proceed with CAR T-cell therapy after coming off protocol therapy, will collect data regarding the success of T-cell manufacturing, infusion and response to therapy in this young population, as the success of this subsequent therapy may be heavily impacted by the effect of protocol therapy on T-cell function. These analyses will be exploratory and descriptive.
After coming off protocol therapy
Predictors of response and resistance to venetoclax and overall protocol therapy
Tidsramme: Before and after venetoclax exposure, up to 3 years

Will study the inter- and intra- patient variability in the expression of apoptotic proteins (e.g., BCL-2, MCL-1, BCL-XL) and apoptotic priming at diagnosis and identify changes that occur during induction therapy in relationship to venetoclax exposure. Will then determine whether the state of BCL-2 specific apoptotic priming correlates with outcome. Will also integrate genomic and molecular features (such as developmental state, signaling, epigenomic, transcriptomic, proteomic and metabolomic states) before and after venetoclax exposure, for those assays where this type of analysis is feasible, to determine biomarkers of response and resistance to therapy for infants with ALL.
Before and after venetoclax exposure, up to 3 years
Impact of subsequent anti-cancer therapy on overall survival
Tidsramme: After coming off protocol therapy

For all patients who remain in study follow-up after coming off protocol therapy, data will be collected regarding subsequent cancer directed therapies received as well as relapse and survival status in order to evaluate the impact of subsequent cancer directed therapy on the overall survival of patients enrolled on this study. These analyses will be exploratory and descriptive.
After coming off protocol therapy
Overall survival (OS) rates
Tidsramme: From randomization to death due to any cause, up to 3 years

Will compare OS rates of infants by arms and to historical OS rates. The OS rates from the date of randomization of patients with KMT2A-R ALL will be compared between Arm A and Arm B. Comparison of OS rates between Arm A and Arm B will be based on a one-sided logrank test with Type I error of 0.15. In addition, OS rates of KMT2A-R patients in Arm A and Arm B will be compared to historical rates observed in similar patients in completed studies such as AALL0631 or AALL15P1. In addition, OS from enrollment of KMT2A-G patients will be compared to historical rates. OS rates will be estimated using the Kaplan-Meier method with Greenwood standard errors. Hazard ratios and confidence intervals will be estimated based on Cox regression models as appropriate. These analyses will be largely exploratory.
From randomization to death due to any cause, up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Erin H Breese, Children's Oncology Group

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2025

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

16. mars 2024

Først innsendt som oppfylte QC-kriteriene

16. mars 2024

Først lagt ut (Faktiske)

19. mars 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2024-01994
  • U10CA180886 (U.S. NIH-stipend/kontrakt)
  • NCI-2024-01994 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • AALL2321 (Annen identifikator: CTEP)
  • AALL2321 (Annen identifikator: Children's Oncology Group)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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