Carboplatino y Etopósido y Ifosfamida en Linfoma de Burkitt recurrente y Linfoma de Burkitt refractario y Linfoma recurrente de células B de alto grado con reordenamientos MYC y BCL2 - Registro de ensayos clínicos

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVES:

I. To compare the progression free survival (PFS) of rituximab (R)-chemotherapy plus glofitamab versus R-chemotherapy alone in patients with newly diagnosed Burkitt lymphoma.

II. To compare the PFS of R-chemotherapy plus glofitamab versus R-chemotherapy alone in patients with newly diagnosed high grade (double hit) B-cell lymphoma with MYC and BCL2 rearrangements.

III. To determine the overall survival of obinutuzumab, rituximab, ifosfamine, carboplatin, etoposide (RICE), and glofitamab in patients with relapsed Burkitt lymphoma.

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) of R-chemotherapy plus glofitamab versus R-chemotherapy alone in patients with Burkitt lymphoma, and patients with high grade B-cell lymphoma with MYC and BCL2 rearrangements.

II. To compare the safety and tolerability of glofitamab combined with R-chemotherapy versus R-chemotherapy alone in patients with Burkitt lymphoma, and patients with high grade B-cell lymphoma with MYC and BCL2 rearrangements.

III. To determine the event free survival (EFS), complete response (CR) and overall response (OR) rates of obinutuzumab, RICE, and glofitamab in patients with relapsed Burkitt and high grade B-cell lymphoma.

IV. To assess how many patients undergo transplant or chimeric antigen receptor T-cell therapy (CART) after treatment with obinutuzumab, RICE, and glofitamab for relapsed Burkitt lymphoma.

EXPLORATORY OBJECTIVES:

I. To assess patient reported outcomes in patients with Burkitt and double hit lymphoma at study enrollment, during treatment and at the end of therapy.

II. To evaluate the completion rate of a lymphoma-specific patient assessment of life survey (PALS) for 7 patient directed questions on social determinants of health (SDH) and assess the impact of the survey collected data on outcomes for all enrolled patients.

OUTLINE: Patients with newly diagnosed Burkitt lymphoma are assigned to cohort 1, patients with double hit lymphoma are assigned to cohort 2, patients with relapsed or refractory Burkitt lymphoma or high grade lymphoma are assigned to cohort 3.

COHORT 1: Patients are randomized to 1 of 2 arms. Patients who received a singe cycle of anthracycline containing chemotherapy will start treatment at cycle 2 22-36 days after cycle 1.

ARM 1: Patients receive either rituximab, cyclophosphamide, doxorubicin, vincristine and methotrexate (RCODOXM)/rituximab, ifosfamide, etoposide, cytarabine (RIVAC) or rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone (DA-REPOCH) treatment per the investigators choice. Patients over the age of 60 or with other co-morbidities are assigned to DA-REPOCH.

RCODOXM/RIVAC:

CYCLES 1 AND 3: Patients receive rituximab intravenously (IV) or rituxan hycela subcutaneously (SC) on day 1, cyclophosphamide IV on days 1 and 2, doxorubicin IV on day 1, vincristine IV on day 1 and 15 and methotrexate IV, over 2-4 hours on day 15.

CYCLES 2 AND 4: Patients receive rituximab IV or rituan hycela SC on day 1, ifosfamide IV and etoposide IV on days 1-5, and cytarabine IV every 12 hours on days 1-2.

Patients without baseline central nervous system (CNS) disease also receive methotrexate intrathecally (IT) and cytarabine IT once per cycle for 4 treatments or methotrexate IT twice per cycle for 8 treatments or alternating methotrexate IT and cytarabine IT twice per cycle for 8 treatments.

Patients with baseline CNS disease also receive methotrexate IT and cytarabine IT twice weekly, methotrexate IT or alternating methotrexate IT and cytarabine IT until cerebrospinal fluid (CSF) clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles.

Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

DA-REPOCH: Patients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone orally (PO) twice daily (BID) on days 1-5.

Patients without baseline CNS disease also receive methotrexate IT and cytarabine IT once per cycle for 4 treatments or methotrexate IT twice per cycle for 8 treatments or alternating methotrexate IT and cytarabine IT twice per cycle for 8 treatments.

Patients with baseline CNS disease also receive methotrexate IT and cytarabine IT twice weekly, methotrexate IT or alternating methotrexate IT and cytarabine IT until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles.

Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo positron emission tomography (PET), computed tomography (CT) scan, and/or magnetic resonance imaging (MRI) and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.

ARM 2: Patients receive either RCODOXM/RIVAC or DA-REPOCH with glofitamab per the investigators choice. Patients over the age of 60 or with other co-morbidities are assigned to DA-REPOCH.

RCODOXM/RIVAC:

CYCLES 1 AND 3: Patients receive rituximab IV or rituxan hycela SC on day 1, cyclophosphamide IV on days 1 and 2, doxorubicin IV on day 1, vincristine IV on day 1 and 15 and methotrexate IV, over 2-4 hours on day 15. Patients also receive glofitamab IV, over 2-4 hours, on day 2 of cycle 3.

CYCLES 2 AND 4: Patients receive rituximab IV or rituan hycela SC on day 1, ifosfamide IV and etoposide IV on days 1-5, and cytarabine IV every 12 hours on days 1-2. Patients also receive glofitamab IV, over 2-4 hours, on day 6 and 15 of cycle 2 and day 6, 22, 43 64 and 85 of cycle 4.

Patients without baseline CNS disease also receive methotrexate IT and cytarabine IT once per cycle for 4 treatments or methotrexate IT twice per cycle for 8 treatments or alternating methotrexate IT and cytarabine IT twice per cycle for 8 treatments. IT treatment can not be given on the same day as glofitamab.

Patients with baseline CNS disease also receive methotrexate IT and cytarabine IT twice weekly, methotrexate IT or alternating methotrexate IT and cytarabine IT until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. IT treatment can not be given on the same day as glofitamab.

Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.

Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

DA-REPOCH: Patients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5. Patients also receive glofitamab IV, over 2-4 hours on day 6 and 15 of cycle 2, day 6 of cycle 3-5 and days 6, 22 and 43 of cycle 6.

Patients without baseline CNS disease also receive methotrexate IT and cytarabine IT once per cycle for 4 treatments or methotrexate IT twice per cycle for 8 treatments or alternating methotrexate IT and cytarabine IT twice per cycle for 8 treatments. IT treatment can not be given on the same day as glofitamab.

Patients with baseline CNS disease also receive methotrexate IT and cytarabine IT twice weekly, methotrexate IT or alternating methotrexate IT and cytarabine IT until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. IT treatment can not be given on the same day as glofitamab.

Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.

COHORT 2: Patients are randomized to 1 of 2 arms.

ARM 3: Patients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5.

Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments.

Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles.

Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.

ARM 4: Patients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5. Patients also receive glofitamab IV, over 2-4 hours, on day 6 and 15 of cycle 2, day 6 of cycle 3-5 and days 6, 22 and 43 of cycle 6.

Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments. IT treatment can not be given on the same day as glofitamab.

Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. IT treatment can not be given on the same day as glofitamab.

Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.

COHORT 3: Patients receive obinutuzumab IV on day 1 of cycle 1, rituximab IV or rituxan hyceka SC on day 4 of cycle 1 and on day 1 of subsequent cycles, ifosfamide IV continuously on day 2, carboplatin, over 1 hour, on day 2, etoposide IV, over 2 hours, on days 1-3 and glofitamab IV, over 2-4 hours, on day 8 and 15 of cycle 1, on day 4 of cycles 2-3 and day 4 and 22 of cycle 4.

Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments. IT treatment can not be given on the same day as glofitamab.

Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. IT treatment can not be given on the same day as glofitamab.

Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Responding patients may come off study any time after cycle 3 to receive transplant or chimeric antigen receptor therapy.

Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months until 5 years.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

271

Fase

Fase 2
Fase 3

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

Adulto
Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

BURKITT LYMPHOMA (BL) COHORT 1: Histologically confirmed Burkitt lymphoma by International Consensus Classification criteria. Patients with Burkitt lymphoma must have one or more of the following adverse risk factors at diagnosis:
- Stage III or IV disease
- Elevated lactate dehydrogenase (LDH) greater than institutional upper limit of normal (ULN)
- Tumor mass ≥ 7 cm
BL COHORT 1: No prior treatment except for pre-phase chemotherapy, pre-phase corticosteroids, or one cycle of chemotherapy as described below.
- Pre-phase chemotherapy with corticosteroids or cyclophosphamide/prednisone is permitted prior to enrollment.
- One cycle of prior chemotherapy (for example, cyclophosphamide, doxorubicin, vincristine and prednisone [CHOP], Polatuzumab-cyclophosphamide doxorubicin and prednisone [CHP], cyclophosphamide, vincristine, doxorubicin and methotrexate [CODOXM], or etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin [EPOCH] [with or without rituximab]) may be administered no more than 21 days prior to enrollment.
- Patients enrolling on study after one cycle of prior anthracycline containing therapy will start the study therapy in cycle 2 and cycle 2 must occur no later than 22-36 days after the start of cycle 1. (If feasible, cycle 2 should start on day 22, but +14 days is permitted to permit recovery from toxicity in cycle 1)
BL COHORT 1: Age ≥ 18 years
BL COHORT 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma
BL COHORT 1: Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (unless attributable to lymphoma)
BL COHORT 1: Platelet count ≥ 75,000/mm^3 (unless attributable to lymphoma)
BL COHORT 1: Calculated (Calc.) creatinine clearance ≥ 50 mL/min (unless attributable to lymphoma)
BL COHORT 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN (unless attributable to lymphoma)
BL COHORT 1: Total bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome) (unless attributable to lymphoma)
BL COHORT 1: International normalization ratio (INR) OR prothrombin time (PT) > 1.5 x institutional ULN (unless attributable to lymphoma)
BL COHORT 1: Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) > 1.5 x institutional ULN (unless attributable to lymphoma)
BL COHORT 1: Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required
BL COHORT 1: Patients with prior malignancy or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (i.e. anthracycline dosing that will exceed recommended lifetime maximum dosing) are eligible for this trial
BL COHORT 1: Patients with HIV are eligible but must be on effective anti-retroviral therapy, with undetectable viral load within 6 months of enrollment
BL COHORT 1: Patients with a history of hepatitis B who are hepatitis B (HepB) surface antigen (Ag) positive and/or HepB core antibody (Ab) positive with undetectable Hep B viral load who start suppressive antiviral therapy prior to chemotherapy are eligible
BL COHORT 1: Patients with a history of hepatitis C infection that have been treated for hepatitis C virus (HCV) and have an undetectable HCV viral load are eligible
BL COHORT 1: No active ischemic heart disease or congestive heart failure, AND adequate cardiac function defined as ejection fraction of ≥ 45%
BL COHORT 1: Patients with CSF/leptomeningeal involvement at diagnosis are eligible. Patients with parenchymal brain involvement at diagnosis are NOT eligible
BL COHORT 1: Patients requiring > 10 mg/day of prednisone or equivalent, for the treatment of conditions other than the control of lymphoma related symptoms, are NOT eligible
BL COHORT 1: Patients with major surgery within 4 weeks other than for diagnosis of lymphoma are NOT eligible
BL COHORT 1: Patients with known active infections, or reactivation of a latent infection (excluding fungal infections of nail bed, hepatitis B on suppressive therapy or treated hepatitis C) requiring hospitalization or treatment with IV antibiotics within 4 weeks of study treatment are NOT eligible
BL COHORT 1: Patients with a prior history of hemophagocytic lymphohistocytosis (HLH) are NOT eligible
BL COHORT 1: Patients with a history of autoimmune disease (including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis) are NOT eligible.

However, patients with autoimmune related hypothyroidism on a stable dose of thyroid replacement hormone, patients with a history of lymphoma related immune thrombocytopenic purpura or hemolytic anemia, and patients with type 1 or type 2 diabetes on a stable insulin regimen are eligible to enroll. In addition, patients with eczema, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may also enroll if the rash covers < 10% of body surface area and the disease is well controlled and requires only topical corticosteroids.

Lastly, patients treated with prior immunotherapeutic agents with a history of any grade 3 events (except for grade 3 endocrinopathy managed with replacement therapy) or grade 1-2 events that did not resolve to baseline with treatment discontinuation are NOT eligible.

BL COHORT 1: Patients with a history of progressive multifocal leukoencephalopathy (PML) are NOT eligible
BL COHORT 1: Patients who have received live, attenuated vaccines within 4 weeks prior to cycle 1 day (D) 1 of study treatment are NOT eligible
DOUBLE HIT LYMPHOMA (DHL) COHORT 2: Histologically confirmed high grade/double hit B-cell lymphoma with MYC and BCL2 translocations by International Consensus Classification (ICC) or World Health Organization (WHO) criteria. Fluorescence in situ hybridization (FISH) For MYC and BCL2 translocations must be performed by the referring site and must be positive for translocations of BOTH MYC and BCL2. Patients found to have BCL6 translocations in addition to BOTH MYC and BCL2 (so called "triple hit lymphoma") are eligible
DHL COHORT 2: Stage II-IV disease per Lugano staging classification
DHL COHORT 2: No prior treatment except for pre-phase chemotherapy, pre-phase corticosteroids, or one cycle of chemotherapy as described below.
- Pre-phase chemotherapy with corticosteroids or cyclophosphamide/prednisone is permitted prior to enrollment.
- One cycle of prior chemotherapy (for example, CHOP, Polatuzumab-CHP, or EPOCH (with or without Rituximab)) may be administered no more than 21 days prior to enrollment.
- Patients enrolling on study after one cycle of prior anthracycline containing therapy will start the study therapy in cycle 2 and cycle 2 must occur no later than 22-36 days after the start of cycle 1. (If feasible, cycle 2 should start on day 22, but +14 days is permitted to permit recovery from toxicity in cycle 1)
DHL COHORT 2: Age ≥ 18 years
DHL COHORT 2: ECOG performance status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma
DHL COHORT 2: Absolute neutrophil count (ANC) ≥ 1,000/mm^ 3 (unless attributable to lymphoma)
DHL COHORT 2: Platelet Count ≥ 75,000/mm^3 (unless attributable to lymphoma)
DHL COHORT 2: Calc. Creatinine Clearance ≥ 50 mL/min (unless attributable to lymphoma)
DHL COHORT 2: AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN (unless attributable to lymphoma)
DHL COHORT 2: Total Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)
DHL COHORT 2: INR OR PT > 1.5 x institutional ULN (unless attributable to lymphoma)
DHL COHORT 2: PTT or aPTT > 1.5 x institutional ULN (unless attributable to lymphoma)
DHL COHORT 2: Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required
DHL COHORT 2: Patients with prior malignancy or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (i.e. anthracycline dosing that will exceed recommended lifetime maximum dosing) are eligible for this trial
DHL COHORT 2: Patients with HIV are eligible but must be on effective anti-retroviral therapy, with undetectable viral load within 6 months of enrollment
DHL COHORT 2: Patients with a history of hepatitis B who are HepB surface Ag positive and/or HepB core Ab positive with undetectable Hep B viral load who who start suppressive antiviral therapy prior to chemotherapy are eligible
DHL COHORT 2: Patients with a history of hepatitis C infection that have been treated for HCV and have an undetectable HCV viral load are eligible
DHL COHORT 2: No active ischemic heart disease or congestive heart failure, AND adequate cardiac function defined as ejection fraction of ≥ 45%
DHL COHORT 2: Patients with CSF/leptomeningeal involvement at diagnosis are eligible. Patients with parenchymal brain involvement at diagnosis are NOT eligible
DHL COHORT 2: Corticosteroid use: Patients requiring > 10 mg/day of prednisone or equivalent, for the treatment of conditions other than the control of lymphoma related symptoms, are NOT eligible
DHL COHORT 2: Patients with major surgery within 4 weeks other than for diagnosis of lymphoma are NOT eligible
DHL COHORT 2: Patients with known active infections, or reactivation of a latent infection (excluding fungal infections of nail bed, hepatitis B on suppressive therapy, or treated hepatitis C) requiring hospitalization or treatment with IV antibiotics within 4 weeks of study treatment are NOT eligible
DHL COHORT 2: Patients with a prior history of HLH are NOT eligible
DHL COHORT 2: Patients with a history of autoimmune disease (including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis) are NOT eligible.

However, patients with autoimmune related hypothyroidism on a stable dose of thyroid replacement hormone, patients with a history of lymphoma related immune thrombocytopenic purpura or hemolytic anemia, and patients with type 1 or type 2 diabetes on a stable insulin regimen are eligible to enroll. In addition, patients with eczema, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may also enroll if the rash covers < 10% of body surface area and the disease is well controlled and requires only topical corticosteroids.

Lastly, patients treated with prior immunotherapeutic agents with a history of any grade 3 events (except for grade 3 endocrinopathy managed with replacement therapy) or grade 1-2 events that did not resolve to baseline with treatment discontinuation are NOT eligible

DHL COHORT 2: Patients with a history of PML are NOT eligible
DHL COHORT 2: Patients who have received live, attenuated vaccines within 4 weeks prior to cycle 1 D1 of study treatment are NOT eligible
RELAPSED BL AND HGL COHORT 3: Histologically confirmed Burkitt lymphoma by International Consensus Classification criteria
RELAPSED BL AND HGL COHORT 3: Patients must have relapsed or refractory disease after at least one prior treatment with chemotherapy or chemoimmunotherapy.
- Prior radiotherapy in addition or in conjunction with prior chemotherapy is permitted.
- Patients who have previously received a bispecific antibody (BsAb) are NOT eligible. However, patients enrolled to the standard arms on cohorts 1 and 2 of this trial who did not receive glofitimab and have relapsed or refractory disease are eligible to enroll on cohort 3.
- Prior treatment with systemic immunotherapeutic agents including antibody drug conjugates, radio-immunoconjugates, or immune/cytokine direct therapy must have occurred within 3 weeks or five half-lives of the drug, whichever is shorter
RELAPSED BL AND HGL COHORT 3: Age ≥ 18 years
RELAPSED BL AND HGL COHORT 3: ECOG Performance Status ≤ 2. ECOG performance status of 3 is permitted if related to lymphoma
RELAPSED BL AND HGL COHORT 3: Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: Platelet Count ≥ 75,000/mm^3 (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: Calc. Creatinine Clearance ≥ 50 mL/min (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: Total bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: INR OR PT > 1.5 x institutional ULN (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: PTT or aPTT > 1.5 x institutional ULN (unless due to Gilbert's Syndrome) (unless attributable to lymphoma)
RELAPSED BL AND HGL COHORT 3: Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required
RELAPSED BL AND HGL COHORT 3: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (i.e. anthracycline dosing that will exceed recommended lifetime maximum dosing) are eligible for this trial
RELAPSED BL AND HGL COHORT 3: Patients with HIV are eligible but must be on effective anti-retroviral therapy, with undetectable viral load within 6 months of enrollment
RELAPSED BL AND HGL COHORT 3: Patients with a history of hepatitis B who are HepB surface Ag positive and/or HepB core Ab positive with undetectable Hep B viral load who are taking suppressive antiviral therapy are eligible
RELAPSED BL AND HGL COHORT 3: Patients with a history of hepatitis C infection that have been treated for HCV and have an undetectable HCV viral load are eligible
RELAPSED BL AND HGL COHORT 3: No active ischemic heart disease or congestive heart failure, AND adequate cardiac function defined as ejection fraction of ≥ 45%
RELAPSED BL AND HGL COHORT 3: Patients with CSF/leptomeningeal involvement at diagnosis are eligible. Patients with parenchymal brain involvement at diagnosis are NOT eligible
RELAPSED BL AND HGL COHORT 3: Corticosteroid use: Patients requiring > 10 mg/day of prednisone or equivalent, for the treatment of conditions other than the control of lymphoma related symptoms, are NOT eligible
RELAPSED BL AND HGL COHORT 3: Patients with major surgery within 4 weeks other than for diagnosis of lymphoma are NOT eligible
RELAPSED BL AND HGL COHORT 3: Patients with known active infections, or reactivation of a latent infection (excluding fungal infections of nail bed, hepatitis B on suppressive therapy, or treated hepatitis C) requiring hospitalization or treatment with IV antibiotics within 4 weeks of study treatment are NOT eligible
RELAPSED BL AND HGL COHORT 3: Patients with a prior history of HLH are NOT eligible
RELAPSED BL AND HGL COHORT 3: Patients with a history of autoimmune disease (including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis) are NOT eligible.

However, patients with autoimmune related hypothyroidism on a stable dose of thyroid replacement hormone, patients with a history of lymphoma related immune thrombocytopenic purpura or hemolytic anemia, and patients with type 1 diabetes on a stable insulin regimen are eligible to enroll. In addition, patients with eczema, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may also enroll if the rash covers < 10% of body surface area and the disease is well controlled and requires only topical corticosteroids.

Lastly, patients treated with prior immunotherapeutic agents with a history of any grade 3 events (except for grade 3 endocrinopathy managed with replacement therapy) or grade 1-2 events that did not resolve to baseline with treatment discontinuation are NOT eligible

RELAPSED BL AND HGL COHORT 3: Patients with a history of PML are NOT eligible
RELAPSED BL AND HGL COHORT 3: Patients who have received live, attenuated vaccines within 4 weeks prior to cycle 1 D1 of study treatment are NOT eligible

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

5

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: Cohort 1 arm 2 RCODOXM/RIVAC or DA-REPOCH and glofitamab) See Detailed Description	Droga: Etopósido Dado IV Otros nombres: Demetil Epipodofilotoxina Etilidina Glucósido EPEG Último Toposar Vepesid PV 16 PV 16-213 VP-16 VP-16-213 VP16 Vicepresidente 16213 VP-16213 VP16213 Droga: Ifosfamida Dado IV Otros nombres: Asta z 4942 Asta Z-4942 Cyfos Holoxano Ifex IFO Célula IFO Ifolem Ifomida Ifosfamidum Ifoxán IFX Ifosfamida Iso-endoxano Isoendoxano Isofosfamida Mitoxana MJF 9325 MJF-9325 Naxamida Seromida Tronoxal Z 4942 Z-4942 Procedimiento: Punción lumbar Someterse a una punción lumbar Otros nombres: LP Punción lumbar Procedimiento: Imagen de resonancia magnética Someterse a una resonancia magnética Otros nombres: Resonancia magnética Resonancia magnetica Exploración de imágenes por resonancia magnética Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear SRES Imágenes de RM Imágenes de RMN RMN Imágenes de resonancia magnética nuclear Imágenes por resonancia magnética (IRM) resonancia magnética nuclear Imágenes por resonancia magnética (procedimiento) Resonancias magnéticas Resonancia magnética estructural Droga: Ciclofosfamida Dado IV Otros nombres: Citoxano CTX (-)-ciclofosfamida 2H-1,3,2-oxazafosforina, 2-[bis(2-cloroetil)amino]tetrahidro-, 2-óxido, monohidrato Carloxano Ciclofosfamida Cicloxal Clafen Clafeno CP monohidrato Célula CYCLO Cicloblastina Ciclofosfano Monohidrato de ciclofosfamida Ciclostina Citofosfano Fosfaseron Genoxal Genuina Ledoxina Mitoxano Neosar Revimmune Siklofosfamid WR-138719 Asta B 518 B-518 B 518 B518 WR 138719 WR138719 Frindovyx Droga: Prednisona Orden de compra dada Otros nombres: Deltasona Orasona .delta.1-cortisona 1, 2-deshidrocortisona Adasona Cortancilo Dacortina DeCortin Decortisilo Decoración Delta 1-cortisona Domo delta Deltacorteno Deltacortisona Deltadehidrocortisona Deltison Deltra Econosona Lisacort Meprosona-F Metacortandracina Meticorten Ofisolona Panafcort Panasol-S Paracorto Perrigo Prednisona PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Prednimento Prednisona Intensol Prednisón Prednitona Promifen Rayos Servisona SK-Prednisona Otro: Administración de encuestas Estudios complementarios Droga: Vincristina Dado IV Otros nombres: Vídeo Leurocristina Vincristina LCR Biológico: Rituximab Dado IV Otros nombres: Rituxan MabThera ABP 798 BI 695500 Anticuerpo monoclonal C2B8 Anticuerpo quimérico anti-CD20 CT-P10 IDEC-102 IDEC-C2B8 Anticuerpo monoclonal IDEC-C2B8 PF-05280586 Riabni Rituximab ABBS Rituximab ARRX Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar GB241 Rituximab Biosimilar IBI301 Rituximab Biosimilar JHL1101 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 Rituximab Biosimilar SIBP-02 rituximab biosimilar TQB2303 Rituximab PVVR Rituximab-arrx Rituximab-pvvr RTXM83 Ruxencia Truxima Rixathon Ikdar Mabtas Rituximab-abbs BI-695500 BI695500 Blitzima IDEC 102 IDEC102 PF 05280586 PF05280586 Ritemvía Rituximab-blit Rituximab-rito Rituximab-rixa Rituximab-rixi Riximyo RTXM 83 RTXM-83 ABP-798 ABP798 TC P10 CTP10 GP 2013 GP-2013 GP2013 Rituximab Biosimilar GP2013 Biológico: Rituximab y Hialuronidasa Humana Dado SC Otros nombres: Rituxan Hycela Rituximab más hialuronidasa Rituximab/hialuronidasa Rituximab/hialuronidasa humana Droga: Doxorrubicina Dado IV Otros nombres: Adriblastina Hidroxidaunomicina Hidroxil daunorrubicina Hidroxildaunorrubicina Procedimiento: Tomografía de emisión de positrones Someterse a una exploración PET Otros nombres: Imágenes médicas, tomografía por emisión de positrones MASCOTA Escaneo de mascotas Tomografía por emisión de positrones Tomografía de emisión de positrones PT Tomografía por emisión de positrones (procedimiento) Procedimiento: Tomografía computarizada Someterse a una tomografía computarizada Otros nombres: Connecticut GATO Análisis de gato Tomografía Axial Computarizada Tomografía axial computarizada Tomografía computarizada tomografía Tomografía axial computarizada (procedimiento) Tomografía computarizada (TC) Escaneo de gato de diagnóstico Tipo de servicio de escaneo de gato de diagnóstico Droga: Citarabina Dado IV o IT Otros nombres: .beta.-Arabinósido de citosina 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona 1-.beta.-D-Arabinofuranosilcitosina 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona 1-Beta-D-arabinofuranosilcitosina 1.beta.-D-Arabinofuranosilcitosina 2(1H)-pirimidinona, 4-amino-1-beta-D-arabinofuranosil- 2(1H)-pirimidinona, 4-amino-1.beta.-D-arabinofuranosil- Alexán Ara-C Célula ARA Arabe Arabinofuranosilcitosina Arabinosilcitosina Aracitidina Aracitina Arabinósido de beta-citosina CHX-3311 Citarabino Citarbel Citosar Arabinósido de citosina Citosina-.beta.-arabinósido Citosina-beta-arabinósido Erpalfa Starasid Tarabina SLP U 19920 U-19920 Udicilo WR-28453 Droga: Metotrexato Dado IV o IT Otros nombres: Abitrexato Folex Mexato MTX Alfa-metopterina Ametopterina Brimexato CL 14377 CL-14377 Emtexate Emtexat Emthexate Farmitrexat Fauldexato PFS de Folex Lantarel Ledertrexato Lumexón Maxtrex Medsatrexato Metex Metoblastina Metotrexato LPF Metotrexato Metilaminopterina Metotrexato Metrotex Mexato-AQ Novatrex Reumatrex Texar Tremetex Trexeron Trixilem WR-19039 Jylamvo Procedimiento: Biopsia de Médula Ósea Someterse a una biopsia de médula ósea Otros nombres: Biopsia de Médula Ósea Biopsia De Médula Ósea Biológico: Glofitamab Dado IV Otros nombres: RO7082859 Anti-CD20 x Anti-CD3 Anticuerpo monoclonal biespecífico RO7082859 RO 7082859 Columví Glofitamab-gxbm RO-7082859 Procedimiento: Biospecimen Collection Undergo blood and/or cerebrospinal fluid collection Otros nombres: Recolección de muestras biológicas Muestra biológica recolectada Coleccion de especimenes Recolección de muestras
Experimental: Cohort 1, arm 1 RCODOXM/RIVAC or DA-REPOCH) See Detailed Description.	Droga: Etopósido Dado IV Otros nombres: Demetil Epipodofilotoxina Etilidina Glucósido EPEG Último Toposar Vepesid PV 16 PV 16-213 VP-16 VP-16-213 VP16 Vicepresidente 16213 VP-16213 VP16213 Droga: Ifosfamida Dado IV Otros nombres: Asta z 4942 Asta Z-4942 Cyfos Holoxano Ifex IFO Célula IFO Ifolem Ifomida Ifosfamidum Ifoxán IFX Ifosfamida Iso-endoxano Isoendoxano Isofosfamida Mitoxana MJF 9325 MJF-9325 Naxamida Seromida Tronoxal Z 4942 Z-4942 Procedimiento: Punción lumbar Someterse a una punción lumbar Otros nombres: LP Punción lumbar Procedimiento: Imagen de resonancia magnética Someterse a una resonancia magnética Otros nombres: Resonancia magnética Resonancia magnetica Exploración de imágenes por resonancia magnética Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear SRES Imágenes de RM Imágenes de RMN RMN Imágenes de resonancia magnética nuclear Imágenes por resonancia magnética (IRM) resonancia magnética nuclear Imágenes por resonancia magnética (procedimiento) Resonancias magnéticas Resonancia magnética estructural Droga: Ciclofosfamida Dado IV Otros nombres: Citoxano CTX (-)-ciclofosfamida 2H-1,3,2-oxazafosforina, 2-[bis(2-cloroetil)amino]tetrahidro-, 2-óxido, monohidrato Carloxano Ciclofosfamida Cicloxal Clafen Clafeno CP monohidrato Célula CYCLO Cicloblastina Ciclofosfano Monohidrato de ciclofosfamida Ciclostina Citofosfano Fosfaseron Genoxal Genuina Ledoxina Mitoxano Neosar Revimmune Siklofosfamid WR-138719 Asta B 518 B-518 B 518 B518 WR 138719 WR138719 Frindovyx Droga: Prednisona Orden de compra dada Otros nombres: Deltasona Orasona .delta.1-cortisona 1, 2-deshidrocortisona Adasona Cortancilo Dacortina DeCortin Decortisilo Decoración Delta 1-cortisona Domo delta Deltacorteno Deltacortisona Deltadehidrocortisona Deltison Deltra Econosona Lisacort Meprosona-F Metacortandracina Meticorten Ofisolona Panafcort Panasol-S Paracorto Perrigo Prednisona PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Prednimento Prednisona Intensol Prednisón Prednitona Promifen Rayos Servisona SK-Prednisona Otro: Administración de encuestas Estudios complementarios Droga: Vincristina Dado IV Otros nombres: Vídeo Leurocristina Vincristina LCR Biológico: Rituximab Dado IV Otros nombres: Rituxan MabThera ABP 798 BI 695500 Anticuerpo monoclonal C2B8 Anticuerpo quimérico anti-CD20 CT-P10 IDEC-102 IDEC-C2B8 Anticuerpo monoclonal IDEC-C2B8 PF-05280586 Riabni Rituximab ABBS Rituximab ARRX Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar GB241 Rituximab Biosimilar IBI301 Rituximab Biosimilar JHL1101 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 Rituximab Biosimilar SIBP-02 rituximab biosimilar TQB2303 Rituximab PVVR Rituximab-arrx Rituximab-pvvr RTXM83 Ruxencia Truxima Rixathon Ikdar Mabtas Rituximab-abbs BI-695500 BI695500 Blitzima IDEC 102 IDEC102 PF 05280586 PF05280586 Ritemvía Rituximab-blit Rituximab-rito Rituximab-rixa Rituximab-rixi Riximyo RTXM 83 RTXM-83 ABP-798 ABP798 TC P10 CTP10 GP 2013 GP-2013 GP2013 Rituximab Biosimilar GP2013 Biológico: Rituximab y Hialuronidasa Humana Dado SC Otros nombres: Rituxan Hycela Rituximab más hialuronidasa Rituximab/hialuronidasa Rituximab/hialuronidasa humana Droga: Doxorrubicina Dado IV Otros nombres: Adriblastina Hidroxidaunomicina Hidroxil daunorrubicina Hidroxildaunorrubicina Procedimiento: Tomografía de emisión de positrones Someterse a una exploración PET Otros nombres: Imágenes médicas, tomografía por emisión de positrones MASCOTA Escaneo de mascotas Tomografía por emisión de positrones Tomografía de emisión de positrones PT Tomografía por emisión de positrones (procedimiento) Procedimiento: Tomografía computarizada Someterse a una tomografía computarizada Otros nombres: Connecticut GATO Análisis de gato Tomografía Axial Computarizada Tomografía axial computarizada Tomografía computarizada tomografía Tomografía axial computarizada (procedimiento) Tomografía computarizada (TC) Escaneo de gato de diagnóstico Tipo de servicio de escaneo de gato de diagnóstico Droga: Citarabina Dado IV o IT Otros nombres: .beta.-Arabinósido de citosina 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona 1-.beta.-D-Arabinofuranosilcitosina 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona 1-Beta-D-arabinofuranosilcitosina 1.beta.-D-Arabinofuranosilcitosina 2(1H)-pirimidinona, 4-amino-1-beta-D-arabinofuranosil- 2(1H)-pirimidinona, 4-amino-1.beta.-D-arabinofuranosil- Alexán Ara-C Célula ARA Arabe Arabinofuranosilcitosina Arabinosilcitosina Aracitidina Aracitina Arabinósido de beta-citosina CHX-3311 Citarabino Citarbel Citosar Arabinósido de citosina Citosina-.beta.-arabinósido Citosina-beta-arabinósido Erpalfa Starasid Tarabina SLP U 19920 U-19920 Udicilo WR-28453 Droga: Metotrexato Dado IV o IT Otros nombres: Abitrexato Folex Mexato MTX Alfa-metopterina Ametopterina Brimexato CL 14377 CL-14377 Emtexate Emtexat Emthexate Farmitrexat Fauldexato PFS de Folex Lantarel Ledertrexato Lumexón Maxtrex Medsatrexato Metex Metoblastina Metotrexato LPF Metotrexato Metilaminopterina Metotrexato Metrotex Mexato-AQ Novatrex Reumatrex Texar Tremetex Trexeron Trixilem WR-19039 Jylamvo Procedimiento: Biopsia de Médula Ósea Someterse a una biopsia de médula ósea Otros nombres: Biopsia de Médula Ósea Biopsia De Médula Ósea Procedimiento: Biospecimen Collection Undergo blood and/or cerebrospinal fluid collection Otros nombres: Recolección de muestras biológicas Muestra biológica recolectada Coleccion de especimenes Recolección de muestras
Experimental: Cohort 2 arm 3 (DA-REPOCH) Patients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5. Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments. Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study. Patients may undergo bone marrow biopsy and blood sample collection throughout the study.	Droga: Etopósido Dado IV Otros nombres: Demetil Epipodofilotoxina Etilidina Glucósido EPEG Último Toposar Vepesid PV 16 PV 16-213 VP-16 VP-16-213 VP16 Vicepresidente 16213 VP-16213 VP16213 Procedimiento: Punción lumbar Someterse a una punción lumbar Otros nombres: LP Punción lumbar Procedimiento: Imagen de resonancia magnética Someterse a una resonancia magnética Otros nombres: Resonancia magnética Resonancia magnetica Exploración de imágenes por resonancia magnética Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear SRES Imágenes de RM Imágenes de RMN RMN Imágenes de resonancia magnética nuclear Imágenes por resonancia magnética (IRM) resonancia magnética nuclear Imágenes por resonancia magnética (procedimiento) Resonancias magnéticas Resonancia magnética estructural Droga: Ciclofosfamida Dado IV Otros nombres: Citoxano CTX (-)-ciclofosfamida 2H-1,3,2-oxazafosforina, 2-[bis(2-cloroetil)amino]tetrahidro-, 2-óxido, monohidrato Carloxano Ciclofosfamida Cicloxal Clafen Clafeno CP monohidrato Célula CYCLO Cicloblastina Ciclofosfano Monohidrato de ciclofosfamida Ciclostina Citofosfano Fosfaseron Genoxal Genuina Ledoxina Mitoxano Neosar Revimmune Siklofosfamid WR-138719 Asta B 518 B-518 B 518 B518 WR 138719 WR138719 Frindovyx Droga: Prednisona Orden de compra dada Otros nombres: Deltasona Orasona .delta.1-cortisona 1, 2-deshidrocortisona Adasona Cortancilo Dacortina DeCortin Decortisilo Decoración Delta 1-cortisona Domo delta Deltacorteno Deltacortisona Deltadehidrocortisona Deltison Deltra Econosona Lisacort Meprosona-F Metacortandracina Meticorten Ofisolona Panafcort Panasol-S Paracorto Perrigo Prednisona PRED Predicor Predicorten Prednicen-M Prednicort Prednidib Prednilonga Prednimento Prednisona Intensol Prednisón Prednitona Promifen Rayos Servisona SK-Prednisona Otro: Administración de encuestas Estudios complementarios Droga: Vincristina Dado IV Otros nombres: Vídeo Leurocristina Vincristina LCR Biológico: Rituximab Dado IV Otros nombres: Rituxan MabThera ABP 798 BI 695500 Anticuerpo monoclonal C2B8 Anticuerpo quimérico anti-CD20 CT-P10 IDEC-102 IDEC-C2B8 Anticuerpo monoclonal IDEC-C2B8 PF-05280586 Riabni Rituximab ABBS Rituximab ARRX Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar GB241 Rituximab Biosimilar IBI301 Rituximab Biosimilar JHL1101 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 Rituximab Biosimilar SIBP-02 rituximab biosimilar TQB2303 Rituximab PVVR Rituximab-arrx Rituximab-pvvr RTXM83 Ruxencia Truxima Rixathon Ikdar Mabtas Rituximab-abbs BI-695500 BI695500 Blitzima IDEC 102 IDEC102 PF 05280586 PF05280586 Ritemvía Rituximab-blit Rituximab-rito Rituximab-rixa Rituximab-rixi Riximyo RTXM 83 RTXM-83 ABP-798 ABP798 TC P10 CTP10 GP 2013 GP-2013 GP2013 Rituximab Biosimilar GP2013 Biológico: Rituximab y Hialuronidasa Humana Dado SC Otros nombres: Rituxan Hycela Rituximab más hialuronidasa Rituximab/hialuronidasa Rituximab/hialuronidasa humana Droga: Doxorrubicina Dado IV Otros nombres: Adriblastina Hidroxidaunomicina Hidroxil daunorrubicina Hidroxildaunorrubicina Procedimiento: Tomografía de emisión de positrones Someterse a una exploración PET Otros nombres: Imágenes médicas, tomografía por emisión de positrones MASCOTA Escaneo de mascotas Tomografía por emisión de positrones Tomografía de emisión de positrones PT Tomografía por emisión de positrones (procedimiento) Procedimiento: Tomografía computarizada Someterse a una tomografía computarizada Otros nombres: Connecticut GATO Análisis de gato Tomografía Axial Computarizada Tomografía axial computarizada Tomografía computarizada tomografía Tomografía axial computarizada (procedimiento) Tomografía computarizada (TC) Escaneo de gato de diagnóstico Tipo de servicio de escaneo de gato de diagnóstico Droga: Citarabina Dado IV o IT Otros nombres: .beta.-Arabinósido de citosina 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona 1-.beta.-D-Arabinofuranosilcitosina 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona 1-Beta-D-arabinofuranosilcitosina 1.beta.-D-Arabinofuranosilcitosina 2(1H)-pirimidinona, 4-amino-1-beta-D-arabinofuranosil- 2(1H)-pirimidinona, 4-amino-1.beta.-D-arabinofuranosil- Alexán Ara-C Célula ARA Arabe Arabinofuranosilcitosina Arabinosilcitosina Aracitidina Aracitina Arabinósido de beta-citosina CHX-3311 Citarabino Citarbel Citosar Arabinósido de citosina Citosina-.beta.-arabinósido Citosina-beta-arabinósido Erpalfa Starasid Tarabina SLP U 19920 U-19920 Udicilo WR-28453 Droga: Metotrexato Dado IV o IT Otros nombres: Abitrexato Folex Mexato MTX Alfa-metopterina Ametopterina Brimexato CL 14377 CL-14377 Emtexate Emtexat Emthexate Farmitrexat Fauldexato PFS de Folex Lantarel Ledertrexato Lumexón Maxtrex Medsatrexato Metex Metoblastina Metotrexato LPF Metotrexato Metilaminopterina Metotrexato Metrotex Mexato-AQ Novatrex Reumatrex Texar Tremetex Trexeron Trixilem WR-19039 Jylamvo Procedimiento: Biopsia de Médula Ósea Someterse a una biopsia de médula ósea Otros nombres: Biopsia de Médula Ósea Biopsia De Médula Ósea Procedimiento: Biospecimen Collection Undergo blood and/or cerebrospinal fluid collection Otros nombres: Recolección de muestras biológicas Muestra biológica recolectada Coleccion de especimenes Recolección de muestras
Experimental: Cohort 2 arm 4 (DA-REPOCH and glofitamab) Patients receive rituximab IV or rituxan hycela SC on day 1, etoposide IV continuously, doxorubicin IV continuously and vincristine IV continuously on days 1-4, cyclophosphamide IV on day 5, and prednisone PO BID on days 1-5. Patients also receive glofitamab IV, over 2-4 hours, on day 6 and 15 of cycle 2, day 6 of cycle 3-5 and days 6, 22 and 43 of cycle 6. Patients without baseline CNS disease may also receive methotrexate IT once per cycle for 4-6 treatments. IT treatment can not be given on the same day as glofitamab. Patients with baseline CNS disease also receive methotrexate IT twice weekly until CSF clears then weekly methotrexate IT for 4 weeks then methotrexate IT once per cycles for remaining cycles. IT treatment can not be given on the same day as glofitamab. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT scan, and/or MRI and lumbar puncture with CSF sample collection throughout the study.	Droga: Etopósido Dado IV Otros nombres: Demetil Epipodofilotoxina Etilidina Glucósido EPEG Último Toposar Vepesid PV 16 PV 16-213 VP-16 VP-16-213 VP16 Vicepresidente 16213 VP-16213 VP16213 Procedimiento: Punción lumbar Someterse a una punción lumbar Otros nombres: LP Punción lumbar Procedimiento: Imagen de resonancia magnética Someterse a una resonancia magnética Otros nombres: Resonancia magnética Resonancia magnetica Exploración de imágenes por resonancia magnética Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear SRES Imágenes de RM Imágenes de RMN RMN Imágenes de resonancia magnética nuclear Imágenes por resonancia magnética (IRM) resonancia magnética nuclear Imágenes por resonancia magnética (procedimiento) Resonancias magnéticas Resonancia magnética estructural Droga: Ciclofosfamida Dado IV Otros nombres: Citoxano CTX (-)-ciclofosfamida 2H-1,3,2-oxazafosforina, 2-[bis(2-cloroetil)amino]tetrahidro-, 2-óxido, monohidrato Carloxano Ciclofosfamida Cicloxal Clafen Clafeno CP monohidrato Célula CYCLO Cicloblastina Ciclofosfano Monohidrato de ciclofosfamida Ciclostina Citofosfano Fosfaseron Genoxal Genuina Ledoxina Mitoxano Neosar Revimmune Siklofosfamid WR-138719 Asta B 518 B-518 B 518 B518 WR 138719 WR138719 Frindovyx Otro: Administración de encuestas Estudios complementarios Droga: Vincristina Dado IV Otros nombres: Vídeo Leurocristina Vincristina LCR Biológico: Rituximab Dado IV Otros nombres: Rituxan MabThera ABP 798 BI 695500 Anticuerpo monoclonal C2B8 Anticuerpo quimérico anti-CD20 CT-P10 IDEC-102 IDEC-C2B8 Anticuerpo monoclonal IDEC-C2B8 PF-05280586 Riabni Rituximab ABBS Rituximab ARRX Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar GB241 Rituximab Biosimilar IBI301 Rituximab Biosimilar JHL1101 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 Rituximab Biosimilar SIBP-02 rituximab biosimilar TQB2303 Rituximab PVVR Rituximab-arrx Rituximab-pvvr RTXM83 Ruxencia Truxima Rixathon Ikdar Mabtas Rituximab-abbs BI-695500 BI695500 Blitzima IDEC 102 IDEC102 PF 05280586 PF05280586 Ritemvía Rituximab-blit Rituximab-rito Rituximab-rixa Rituximab-rixi Riximyo RTXM 83 RTXM-83 ABP-798 ABP798 TC P10 CTP10 GP 2013 GP-2013 GP2013 Rituximab Biosimilar GP2013 Biológico: Rituximab y Hialuronidasa Humana Dado SC Otros nombres: Rituxan Hycela Rituximab más hialuronidasa Rituximab/hialuronidasa Rituximab/hialuronidasa humana Droga: Doxorrubicina Dado IV Otros nombres: Adriblastina Hidroxidaunomicina Hidroxil daunorrubicina Hidroxildaunorrubicina Procedimiento: Tomografía de emisión de positrones Someterse a una exploración PET Otros nombres: Imágenes médicas, tomografía por emisión de positrones MASCOTA Escaneo de mascotas Tomografía por emisión de positrones Tomografía de emisión de positrones PT Tomografía por emisión de positrones (procedimiento) Procedimiento: Tomografía computarizada Someterse a una tomografía computarizada Otros nombres: Connecticut GATO Análisis de gato Tomografía Axial Computarizada Tomografía axial computarizada Tomografía computarizada tomografía Tomografía axial computarizada (procedimiento) Tomografía computarizada (TC) Escaneo de gato de diagnóstico Tipo de servicio de escaneo de gato de diagnóstico Droga: Citarabina Dado IV o IT Otros nombres: .beta.-Arabinósido de citosina 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona 1-.beta.-D-Arabinofuranosilcitosina 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona 1-Beta-D-arabinofuranosilcitosina 1.beta.-D-Arabinofuranosilcitosina 2(1H)-pirimidinona, 4-amino-1-beta-D-arabinofuranosil- 2(1H)-pirimidinona, 4-amino-1.beta.-D-arabinofuranosil- Alexán Ara-C Célula ARA Arabe Arabinofuranosilcitosina Arabinosilcitosina Aracitidina Aracitina Arabinósido de beta-citosina CHX-3311 Citarabino Citarbel Citosar Arabinósido de citosina Citosina-.beta.-arabinósido Citosina-beta-arabinósido Erpalfa Starasid Tarabina SLP U 19920 U-19920 Udicilo WR-28453 Droga: Metotrexato Dado IV o IT Otros nombres: Abitrexato Folex Mexato MTX Alfa-metopterina Ametopterina Brimexato CL 14377 CL-14377 Emtexate Emtexat Emthexate Farmitrexat Fauldexato PFS de Folex Lantarel Ledertrexato Lumexón Maxtrex Medsatrexato Metex Metoblastina Metotrexato LPF Metotrexato Metilaminopterina Metotrexato Metrotex Mexato-AQ Novatrex Reumatrex Texar Tremetex Trexeron Trixilem WR-19039 Jylamvo Procedimiento: Biopsia de Médula Ósea Someterse a una biopsia de médula ósea Otros nombres: Biopsia de Médula Ósea Biopsia De Médula Ósea Biológico: Glofitamab Dado IV Otros nombres: RO7082859 Anti-CD20 x Anti-CD3 Anticuerpo monoclonal biespecífico RO7082859 RO 7082859 Columví Glofitamab-gxbm RO-7082859 Procedimiento: Biospecimen Collection Undergo blood and/or cerebrospinal fluid collection Otros nombres: Recolección de muestras biológicas Muestra biológica recolectada Coleccion de especimenes Recolección de muestras
Experimental: Cohort 3 (RICE and glofitamab) See Detailed Description	Droga: Carboplatino Dado IV Otros nombres: Blastocarbo Carboplat Carboplatino Hexal Carboplatino Carbosina Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorín Novoplatino Paraplatino Paraplatino AQ Platinado Ribocarbo JM8 Droga: Etopósido Dado IV Otros nombres: Demetil Epipodofilotoxina Etilidina Glucósido EPEG Último Toposar Vepesid PV 16 PV 16-213 VP-16 VP-16-213 VP16 Vicepresidente 16213 VP-16213 VP16213 Droga: Ifosfamida Dado IV Otros nombres: Asta z 4942 Asta Z-4942 Cyfos Holoxano Ifex IFO Célula IFO Ifolem Ifomida Ifosfamidum Ifoxán IFX Ifosfamida Iso-endoxano Isoendoxano Isofosfamida Mitoxana MJF 9325 MJF-9325 Naxamida Seromida Tronoxal Z 4942 Z-4942 Procedimiento: Punción lumbar Someterse a una punción lumbar Otros nombres: LP Punción lumbar Procedimiento: Imagen de resonancia magnética Someterse a una resonancia magnética Otros nombres: Resonancia magnética Resonancia magnetica Exploración de imágenes por resonancia magnética Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear SRES Imágenes de RM Imágenes de RMN RMN Imágenes de resonancia magnética nuclear Imágenes por resonancia magnética (IRM) resonancia magnética nuclear Imágenes por resonancia magnética (procedimiento) Resonancias magnéticas Resonancia magnética estructural Otro: Administración de encuestas Estudios complementarios Biológico: Rituximab Dado IV Otros nombres: Rituxan MabThera ABP 798 BI 695500 Anticuerpo monoclonal C2B8 Anticuerpo quimérico anti-CD20 CT-P10 IDEC-102 IDEC-C2B8 Anticuerpo monoclonal IDEC-C2B8 PF-05280586 Riabni Rituximab ABBS Rituximab ARRX Rituximab Biosimilar ABP 798 Rituximab Biosimilar BI 695500 Rituximab Biosimilar CT-P10 Rituximab Biosimilar GB241 Rituximab Biosimilar IBI301 Rituximab Biosimilar JHL1101 Rituximab Biosimilar PF-05280586 Rituximab Biosimilar RTXM83 Rituximab Biosimilar SAIT101 Rituximab Biosimilar SIBP-02 rituximab biosimilar TQB2303 Rituximab PVVR Rituximab-arrx Rituximab-pvvr RTXM83 Ruxencia Truxima Rixathon Ikdar Mabtas Rituximab-abbs BI-695500 BI695500 Blitzima IDEC 102 IDEC102 PF 05280586 PF05280586 Ritemvía Rituximab-blit Rituximab-rito Rituximab-rixa Rituximab-rixi Riximyo RTXM 83 RTXM-83 ABP-798 ABP798 TC P10 CTP10 GP 2013 GP-2013 GP2013 Rituximab Biosimilar GP2013 Biológico: Rituximab y Hialuronidasa Humana Dado SC Otros nombres: Rituxan Hycela Rituximab más hialuronidasa Rituximab/hialuronidasa Rituximab/hialuronidasa humana Procedimiento: Tomografía de emisión de positrones Someterse a una exploración PET Otros nombres: Imágenes médicas, tomografía por emisión de positrones MASCOTA Escaneo de mascotas Tomografía por emisión de positrones Tomografía de emisión de positrones PT Tomografía por emisión de positrones (procedimiento) Procedimiento: Tomografía computarizada Someterse a una tomografía computarizada Otros nombres: Connecticut GATO Análisis de gato Tomografía Axial Computarizada Tomografía axial computarizada Tomografía computarizada tomografía Tomografía axial computarizada (procedimiento) Tomografía computarizada (TC) Escaneo de gato de diagnóstico Tipo de servicio de escaneo de gato de diagnóstico Droga: Citarabina Dado IV o IT Otros nombres: .beta.-Arabinósido de citosina 1-.beta.-D-Arabinofuranosil-4-amino-2(1H)pirimidinona 1-.beta.-D-Arabinofuranosilcitosina 1-Beta-D-arabinofuranosil-4-amino-2(1H)pirimidinona 1-Beta-D-arabinofuranosilcitosina 1.beta.-D-Arabinofuranosilcitosina 2(1H)-pirimidinona, 4-amino-1-beta-D-arabinofuranosil- 2(1H)-pirimidinona, 4-amino-1.beta.-D-arabinofuranosil- Alexán Ara-C Célula ARA Arabe Arabinofuranosilcitosina Arabinosilcitosina Aracitidina Aracitina Arabinósido de beta-citosina CHX-3311 Citarabino Citarbel Citosar Arabinósido de citosina Citosina-.beta.-arabinósido Citosina-beta-arabinósido Erpalfa Starasid Tarabina SLP U 19920 U-19920 Udicilo WR-28453 Droga: Metotrexato Dado IV o IT Otros nombres: Abitrexato Folex Mexato MTX Alfa-metopterina Ametopterina Brimexato CL 14377 CL-14377 Emtexate Emtexat Emthexate Farmitrexat Fauldexato PFS de Folex Lantarel Ledertrexato Lumexón Maxtrex Medsatrexato Metex Metoblastina Metotrexato LPF Metotrexato Metilaminopterina Metotrexato Metrotex Mexato-AQ Novatrex Reumatrex Texar Tremetex Trexeron Trixilem WR-19039 Jylamvo Biológico: Obinutuzumab Dado IV Otros nombres: Gaziva RO5072759 GA101 Anticuerpo monoclonal anti-CD20 R7159 GA-101 huMAB(CD20) R7159 RO 5072759 RO-5072759 AG 101 $ 7159 R-7159 Procedimiento: Biopsia de Médula Ósea Someterse a una biopsia de médula ósea Otros nombres: Biopsia de Médula Ósea Biopsia De Médula Ósea Biológico: Glofitamab Dado IV Otros nombres: RO7082859 Anti-CD20 x Anti-CD3 Anticuerpo monoclonal biespecífico RO7082859 RO 7082859 Columví Glofitamab-gxbm RO-7082859 Procedimiento: Biospecimen Collection Undergo blood and/or cerebrospinal fluid collection Otros nombres: Recolección de muestras biológicas Muestra biológica recolectada Coleccion de especimenes Recolección de muestras

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Progression free survival (PFS) (cohort 1) (phase II) Periodo de tiempo: from randomization to the time of documented disease progression or death due to any cause	The median PFS will be summarized by sex with corresponding 95% confidence intervals.	from randomization to the time of documented disease progression or death due to any cause
PFS (cohort 1) (phase III) Periodo de tiempo: At 24 months	PFS defined as from randomization to the time of documented disease progression or death due to any cause. Will be as estimated using the methods of Kaplan and Meier. The median PFS and the 24-month PFS rates will be summarized by sex with corresponding 95% confidence intervals.	At 24 months
PFS (cohort 2) (phase II) Periodo de tiempo: From randomization to the time of documented disease progression or death due to any cause, up to 5 years	The median PFS will be summarized by sex with corresponding 95% confidence intervals.	From randomization to the time of documented disease progression or death due to any cause, up to 5 years
PFS (cohort 2) (phase III) Periodo de tiempo: At 24 months	PFS defined as from randomization to the time of documented disease progression or death due to any cause. Will be as estimated using the methods of Kaplan and Meier. The median PFS and the 24-month PFS rates will be summarized by sex with corresponding 95% confidence intervals.	At 24 months
Overall survival (cohort 3) Periodo de tiempo: At 12 months after start of treatment		At 12 months after start of treatment

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Overall survival (OS) Periodo de tiempo: From randomization to the time of death due to any cause, up to 5 years	Will be evaluated between the treatment arms for each of the cohorts. Kaplan Meier methods will be used to estimate key aspects of the OS distributions for each of the treatment arms, and logrank tests will be used to compare these distributions between arms.	From randomization to the time of death due to any cause, up to 5 years
Event free survival (EFS) Periodo de tiempo: From randomization date until the earlier of non-protocol lymphoma therapy, disease progression or death from any cause, up to 5 years	Will be evaluated between the treatment arms for each of the cohorts. Kaplan Meier methods will be used to estimate key aspects of the EFS distributions for each of the treatment arms, and logrank tests will be used to compare these distributions between arms.	From randomization date until the earlier of non-protocol lymphoma therapy, disease progression or death from any cause, up to 5 years
Overall response rate (ORR) Periodo de tiempo: Up to 5 years	Defined as the number of patients achieving complete or partial response according to either the computed tomography(CT)-based or positron emission tomography (PET)-CT-based Lugano criteria, divided by the number of evaluable patients. will be estimated by treatment arm, and a 95% binomial confidence interval for the estimated ORR will be provided. Will be evaluated between the treatment arms for each of the cohorts.	Up to 5 years
Complete response rate Periodo de tiempo: Up to 5 years	Defined as the number of patients achieving complete response according to either the CT-based or PET-CT-based Lugano criteria, divided by the number of evaluable patients. The CR rate will be estimated by treatment arm, and a 95% binomial confidence interval for the estimated CR rate will be provided.	Up to 5 years
Transplant or chimeric antigen receptor t-cell (CAR-T) rate (cohort 3) Periodo de tiempo: Up to 5 years	Defined as the number of Cohort 3 patients who undergo transplant or CAR-T after treatment with Rituximab-Ifosfamide-Carboplatin-Etoposide plus Glofitamab, divided by the number of Cohort 3 patients who receive at least one dose of protocol therapy. The transplant or CAR-T rate will be estimated and the corresponding 95% binomial confidence interval will be provided.	Up to 5 years
Incidence of adverse events (AEs) Periodo de tiempo: Up to 5 years	Will be summarized per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5 and Patient Reported Outcome-CTCAE, and where toxicities will be defined as adverse events that are deemed to be at least possibly treatment-related. The maximum grade for each type of treatment-related AE will be recorded for each patient, and the frequency of each will be summarized by treatment arm. Frequency tables and graphical evaluations of AEs and treatment-related AEs will be summarized and evaluated to assess if there are any patterns or differences in the rates or types of AEs.	Up to 5 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Cancer Institute (NCI)

Investigadores

Investigador principal: Kristie A Blum, Alliance for Clinical Trials in Oncology

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de octubre de 2026

Finalización primaria (Estimado)

1 de noviembre de 2033

Finalización del estudio (Estimado)

1 de noviembre de 2033

Fechas de registro del estudio

Enviado por primera vez

22 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

NCI-2026-05193 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
U10CA180821 (Subvención/contrato del NIH de EE. UU.)
A052401 (Otro identificador: CTEP)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit Lymphoma

A Randomized Phase 2/3 Study the Bispecific Antibody (BsAb), Glofitamab, Plus Chemoimmunotherapy in Newly Diagnosed and Relapsed Burkitt and High-Grade (Double Hit) B-Cell Lymphomas With MYC and BCL2 Rearrangements

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Descripción detallada

Tipo de estudio

Inscripción (Estimado)

Fase

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

Acepta Voluntarios Saludables

Descripción

Plan de estudios

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo

Intervención / Tratamiento

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Medidas de resultado secundarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Colaboradores e Investigadores

Patrocinador

Investigadores

Fechas de registro del estudio

Fechas importantes del estudio

Inicio del estudio (Estimado)

Finalización primaria (Estimado)

Finalización del estudio (Estimado)

Fechas de registro del estudio

Enviado por primera vez

Primero enviado que cumplió con los criterios de control de calidad

Publicado por primera vez (Actual)

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización enviada que cumplió con los criterios de control de calidad

Última verificación

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

producto fabricado y exportado desde los EE. UU.