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Une étude comparant l'association du dasatinib et d'un traitement de chimiothérapie avec ou sans blinatumomab pour les enfants, les adolescents et les jeunes adultes atteints de leucémie lymphoblastique aiguë à cellules B de classe B de Philadelphie positive (Ph +) ou de type Philadelphie (Ph-Like) -TOUS)

24 octobre 2026 mis à jour par: National Cancer Institute (NCI)

Un essai international randomisé de phase 3 sur l'imatinib et la chimiothérapie avec ou sans blinatumomab chez des patients atteints de leucémie lymphoblastique aiguë à cellules B de classe B nouvellement diagnostiquée à chromosome Philadelphie positif ou de type Philadelphie

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVES:

I. To estimate the 3-year event free survival (EFS) of children, adolescents, and young adults <25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B- ALL who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib.

II. To estimate the 3-year EFS of children, adolescents, and young adults <25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions.

III. To describe the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays > 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI).

SECONDARY OBJECTIVES:

I. To estimate the 3-year overall survival (OS) of patients with Ph+ and ABL-class Ph-like B-ALL, respectively.

II. To estimate the 3-year EFS, disease-free survival (DFS), cumulative incidence rates (CIR) of relapse, and treatment related mortality (TRM), and OS of patients with ABL-class Ph-like B-ALL stratified by their underlying ABL-class fusion subtypes.

III. To describe rates of end of consolidation (EOC)/timepoint 2 (TP2) minimal residual disease (MRD) negativity defined as <1x10-4 or <0.01% for patients with Ph+ B-ALL.

IV. To describe rates of EOC/TP2 MRD negativity defined as <1x10-4 or <0.01% for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes.

EXPLORATORY OBJECTIVES:

I. To describe rates of end of induction (EOI)/timepoint 1 (TP1) bone marrow MRD negativity defined as <1x10-4 or <0.01% with the introduction of the relevant TKI during Induction for patients with Ph+ and ABL-class Ph-like B-ALL, respectively.

II. To describe the outcomes of patients with Ph+ and ABL-class Ph-like B-ALL who are removed from protocol therapy due to Consolidation Failure.

III. To describe the percentage of patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy and their outcomes.

IV. To describe the impact of MRD by next-generation sequencing (NGS) at End of Consolidation on outcomes for patients with Ph+ and ABL-class Ph-like B-ALL.

V. To describe the clinical characteristics and outcomes of patients with chronic myeloid leukemia-like biology.

VI. To describe the immune function of patients with Ph+ and ABL-class Ph-like B-ALL pre- and post-blinatumomab plus TKI and correlate with treatment response.

VII. To describe the TKI levels in the plasma and cerebrospinal fluid of children with Ph+ and ABL-class Ph-like B-ALL over the treatment course and correlate with outcome VIII. To describe the impact of TKIs and high-dose methotrexate interaction and identify clinical and biologic factors influencing methotrexate clearance.

OUTLINE:

STRATUM I (PH+ B-ALL PATIENTS):

INDUCTION PART I: Patients receive induction chemotherapy on days 1-14 as per standard of care (SOC).

INDUCTION PART II: Patients receive dasatinib PO once daily (QD) on days 15-29, daunorubicin intravenously (IV) over 15 minutes on days 15 and 22, prednisolone or prednisone PO twice daily (BID) on days 15-28, vincristine IV on days 15 and 22, methotrexate intrathecally (IT) on days 15, 22, and 29, and cytarabine IT on days 18 and 25 if central nervous system (CNS)-3 at study entry.

BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or intravenously (IV) on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study. Patients may undergo radiation therapy in 12 QD fractions.

BLINATUMOMAB BLOCK II: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study.

INTERIM MAINTENANCE I: Patients receive dasatinib PO QD until the end of interim maintenance I, mercaptopurine PO QD on days 1-56, vincristine IV on days 8, 22, 36, and 50, methotrexate IT on days 8 and 36, high-dose methotrexate IV over 24 hours on days 8, 22, 36 and 50, and leucovorin PO or IV on days 10, 11, 24, 25, 38, 39, 52 and 53 over 9 weeks on study.

BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, dasatinib PO QD on days 1-35, and methotrexate IT on day 1 over 5 weeks on study.

DELAYED INTENSIFICATION PART I: Patients receive dasatinib PO QD on days 1-28, methotrexate IT on day 1, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin IV over 15 minutes on days 1, 8, and 15, vincristine IV on days 1, 8, and 15, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on day 4 over 4 weeks on study.

DELAYED INTENSIFICATION PART II: Patients receive dasatinib PO QD on day 29 until the end of delayed intensification part II, cyclophosphamide IV over 60 minutes on day 29, cytarabine IV over 30 minutes on days 29-32 and 36-39, methotrexate IT on days 29 and 36, thioguanine PO on days 29-42, pegaspargase IV or calaspargase pegol on day 43 and vincristine IV on days 43 and 50 over 5 weeks on study.

INTERIM MAINTENANCE PART II: Patients receive dasatinib PO QD on day 1 until the end of interim maintenance part II, methotrexate IV on days 1, 11, 21, 31, and 41, vincristine IV on 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on days 2, 22 or 23 over 8 weeks on study.

MAINTENANCE CYCLES I-II: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on days 1 and 29, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study.

MAINTENANCE CYCLES III AND SUBSEQUENT CYCLES: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study. Cycles repeat every 12 weeks for 2 years from the start of Induction therapy in the absence of disease progression or unacceptable toxicity.

STRATUM II (PDGFRB ABL-CLASS FUSIONS):

BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, imatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study. Patients may undergo radiation therapy in 12 QD fractions.

BLINATUMOMAB BLOCK II: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, imatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study.

INTERIM MAINTENANCE I: Patients receive imatinib PO QD until the end of interim maintenance I, mercaptopurine PO QD on days 1-56, vincristine IV on days 8, 22, 36, and 50, methotrexate IT on days 8 and 36, high-dose methotrexate IV over 24 hours on days 8, 22, 36 and 50, and leucovorin PO or IV on days 10, 11, 24, 25, 38, 39, 52 and 53 over 9 weeks on study.

BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, imatinib PO QD on days 1-35, and methotrexate IT on day 1 over 5 weeks on study.

DELAYED INTENSIFICATION PART I: Patients receive imatinib PO QD on days 1-28, methotrexate IT on day 1, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin IV over 15 minutes on days 1, 8, and 15, vincristine IV on days 1, 8, and 15, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on day 4 over 9 weeks on study.

DELAYED INTENSIFICATION PART II: Patients receive imatinib PO QD on day 29 until the end of Delayed Intensification part II, cyclophosphamide IV over 30-60 minutes on day 29, cytarabine IV over 30 minutes on days 29-32 and 36-39, methotrexate IT on days 29 and 36, thioguanine PO on days 29-42, and pegaspargase IV or calaspargase pegol IV on day 43, and vincristine IV on days 43 and 50 over 5 weeks on study.

INTERIM MAINTENANCE II: Patients receive imatinib PO QD until the end of interim maintenance II, methotrexate IV and vincristine IV on days 1, 11, 21, 31 and 41, methotrexate IT on days 1 and 31, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on days 2, 22 or 23 over 8 weeks on study.

MAINTENANCE CYCLES I-II: Patients receive imatinib PO QD on days 1-84, methotrexate IT on days 1 and 29, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study.

MAINTENANCE CYCLES III AND SUBSEQUENT CYCLES: Patients receive imatinib PO QD on days 1-84, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study. Cycles repeat every 12 weeks for 2 years from the start of Induction therapy in the absence of disease progression or unacceptable toxicity.

STRATUM III (NON-PDGFRB ABL-CLASS FUSIONS):

BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study. Patients may undergo radiation therapy in 12 QD fractions.

BLINATUMOMAB BLOCK II: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on days 1 and 15 over 5 weeks on study.

INTERIM MAINTENANCE I: Patients receive dasatinib PO QD until the end of interim maintenance I, mercaptopurine PO QD on days 1-56, vincristine IV on days 8, 22, 36, and 50, methotrexate IT on days 8 and 36, high-dose methotrexate IV over 24 hours on days 8, 22, 36 and 50, and leucovorin PO or IV on days 10, 11, 24, 25, 38, 39, 52 and 53 over 9 weeks on study.

BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, dasatinib PO on days 1-35, and methotrexate IT on day 1 over 5 weeks on study.

DELAYED INTENSIFICATION PART I: Patients receive dasatinib PO QD on days 1-28, methotrexate IT on day 1, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin IV over 15 minutes on days 1, 8, and 15, vincristine IV on days 1, 8, and 15, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on day 4 over 4 weeks on study.

DELAYED INTENSIFICATION PART II: Patients receive dasatinib PO QD and methotrexate IT on day 29 until the end of Delayed Intensification part II, cyclophosphamide IV over 30-60 minutes on day 29, cytarabine IV over 30 minutes on days 29-32 and 36-39, methotrexate IT on days 29 and 36, thioguanine PO on days 29-42, pegaspargase IV or calaspargase pegol on day 43 and vincristine IV on days 43 and 50 over 5 weeks on study.

INTERIM MAINTENANCE II: Patients receive dasatinib PO QD until the end of interim maintenance II, methotrexate IV and vincristine IV on days 1, 11, 21, 31 and 41, methotrexate IT on days 1 and 31, and pegaspargase IV or calaspargase pegol IV over 1-2 hours on days 2, 22 or 23 over 8 weeks on study.

MAINTENANCE CYCLES I-II: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on days 1 and 29, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study.

MAINTENANCE CYCLES III AND SUBSEQUENT CYCLES: Patients receive dasatinib PO QD on days 1-84, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, vincristine IV on days 1, 29 and 57, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 on study. Cycles repeat every 12 weeks for 2 years from the start of Induction therapy in the absence of disease progression or unacceptable toxicity.

All patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo blood and cerebrospinal fluid (CSF) sample collection and bone marrow biopsy throughout the study and as clinically indicated on study.

Type d'étude

Interventionnel

Inscription (Estimé)

222

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Australie
    • New South Wales
      • Hunter Regional Mail Centre, New South Wales, Australie, 2310
        • Recrutement
        • John Hunter Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: (02) 4985 5180
        • Chercheur principal:
          • Kristy McCarthy
    • Queensland
      • South Brisbane, Queensland, Australie, 4101
        • Recrutement
        • Queensland Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 61 7 3068 1111
        • Chercheur principal:
          • Christopher J. Fraser
    • Victoria
      • Parkville, Victoria, Australie, 3052
        • Recrutement
        • Royal Children's Hospital
        • Contact:
        • Chercheur principal:
          • Stacie S. Wang
    • Western Australia
      • Perth, Western Australia, Australie, 6009
  • Canada
      • Québec, Canada, G1V 4G2
        • Recrutement
        • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
        • Chercheur principal:
          • Bruno Michon
        • Contact:
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Suspendu
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recrutement
        • University of Alberta Hospital
        • Contact:
        • Chercheur principal:
          • Sarah J. McKillop
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Suspendu
        • British Columbia Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recrutement
        • CancerCare Manitoba
        • Contact:
        • Chercheur principal:
          • Stephanie M. Villeneuve
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recrutement
        • IWK Health Centre
        • Contact:
        • Chercheur principal:
          • Chelsea Ash
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recrutement
        • McMaster Children's Hospital at Hamilton Health Sciences
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 905-521-2100
        • Chercheur principal:
          • Uma H. Athale
      • Toronto, Ontario, Canada, M5G 1X8
        • Recrutement
        • Hospital for Sick Children
        • Chercheur principal:
          • Sumit Gupta
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Recrutement
        • The Montreal Children's Hospital of the MUHC
        • Contact:
        • Chercheur principal:
          • Stephanie Mourad
      • Montreal, Quebec, Canada, H3T 1C5
        • Recrutement
        • Centre Hospitalier Universitaire Sainte-Justine
        • Chercheur principal:
          • Monia Marzouki
        • Contact:
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recrutement
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
        • Contact:
        • Chercheur principal:
          • Stephanie Vairy
  • Porto Rico
      • San Juan, Porto Rico, 00926
        • Recrutement
        • University Pediatric Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 787-474-0333
        • Chercheur principal:
          • Maria E. Echevarria
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35233
        • Recrutement
        • Children's Hospital of Alabama
        • Contact:
        • Chercheur principal:
          • Matthew A. Kutny
    • Arizona
      • Phoenix, Arizona, États-Unis, 85016
        • Recrutement
        • Phoenix Childrens Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 602-546-0920
        • Chercheur principal:
          • Dana B. Salzberg
      • Tucson, Arizona, États-Unis, 85719
        • Recrutement
        • Banner University Medical Center - Tucson
        • Contact:
        • Chercheur principal:
          • Monica M. Davini
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72202-3591
        • Recrutement
        • Arkansas Children's Hospital
        • Chercheur principal:
          • Michael W. Bishop
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 501-364-7373
    • California
      • Downey, California, États-Unis, 90242
        • Recrutement
        • Kaiser Permanente Downey Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 626-564-3455
        • Chercheur principal:
          • Robert M. Cooper
      • Loma Linda, California, États-Unis, 92354
        • Recrutement
        • Loma Linda University Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 909-558-4050
        • Chercheur principal:
          • Albert Kheradpour
      • Long Beach, California, États-Unis, 90806
        • Recrutement
        • Miller Children's and Women's Hospital Long Beach
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 562-933-5600
        • Chercheur principal:
          • Jacqueline N. Casillas
      • Los Angeles, California, États-Unis, 90027
        • Recrutement
        • Children's Hospital Los Angeles
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 323-361-4110
        • Chercheur principal:
          • Andrew Doan
      • Madera, California, États-Unis, 93636
        • Recrutement
        • Valley Children's Hospital
        • Contact:
        • Chercheur principal:
          • Ruetima Titapiwatanakun
      • Oakland, California, États-Unis, 94611
        • Recrutement
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Chercheur principal:
          • Aarati V. Rao
      • Oakland, California, États-Unis, 94609
        • Recrutement
        • UCSF Benioff Children's Hospital Oakland
        • Chercheur principal:
          • Karen R. Rabin
        • Contact:
      • Orange, California, États-Unis, 92868
        • Recrutement
        • Children's Hospital of Orange County
        • Contact:
        • Chercheur principal:
          • Elyssa M. Rubin
      • Palo Alto, California, États-Unis, 94304
        • Recrutement
        • Lucile Packard Children's Hospital Stanford University
        • Contact:
        • Chercheur principal:
          • Jay Michael S. Balagtas
      • Sacramento, California, États-Unis, 95817
        • Recrutement
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 916-734-3089
        • Chercheur principal:
          • Marcio H. Malogolowkin
      • San Diego, California, États-Unis, 92123
        • Recrutement
        • Rady Children's Hospital - San Diego
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 858-966-5934
        • Chercheur principal:
          • William D. Roberts
      • San Francisco, California, États-Unis, 94158
        • Recrutement
        • UCSF Medical Center-Mission Bay
        • Contact:
        • Chercheur principal:
          • Karen R. Rabin
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Recrutement
        • Children's Hospital Colorado
        • Contact:
        • Chercheur principal:
          • Kelly W. Maloney
    • Connecticut
      • Hartford, Connecticut, États-Unis, 06106
        • Recrutement
        • Connecticut Children's Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 860-545-9981
        • Chercheur principal:
          • Michael S. Isakoff
      • New Haven, Connecticut, États-Unis, 06520
        • Recrutement
        • Yale University
        • Contact:
        • Chercheur principal:
          • Farzana Pashankar
    • Delaware
      • Wilmington, Delaware, États-Unis, 19803
        • Recrutement
        • Alfred I duPont Hospital for Children
        • Contact:
        • Chercheur principal:
          • Emi H. Caywood
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20010
        • Recrutement
        • Children's National Medical Center
        • Chercheur principal:
          • Jeffrey S. Dome
        • Contact:
      • Washington D.C., District of Columbia, États-Unis, 20007
        • Recrutement
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 202-444-2223
        • Chercheur principal:
          • Caileigh Pudela
    • Florida
      • Fort Myers, Florida, États-Unis, 33908
        • Recrutement
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
        • Chercheur principal:
          • Emad K. Salman
      • Gainesville, Florida, États-Unis, 32610
        • Recrutement
        • UF Health Cancer Institute - Gainesville
        • Chercheur principal:
          • Brian Stover
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 352-273-8010
      • Hollywood, Florida, États-Unis, 33021
        • Recrutement
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 954-265-1847
          • E-mail: OHR@mhs.net
        • Chercheur principal:
          • Iftikhar Hanif
      • Jacksonville, Florida, États-Unis, 32207
        • Recrutement
        • Nemours Children's Clinic-Jacksonville
        • Contact:
        • Chercheur principal:
          • Emi H. Caywood
      • Miami, Florida, États-Unis, 33136
        • Recrutement
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 305-243-2647
        • Chercheur principal:
          • Julio C. Barredo
      • Orlando, Florida, États-Unis, 32806
        • Recrutement
        • Arnold Palmer Hospital for Children
        • Contact:
        • Chercheur principal:
          • Zhongbo Hu
      • Orlando, Florida, États-Unis, 32827
        • Recrutement
        • Nemours Children's Hospital
        • Contact:
        • Chercheur principal:
          • Emi H. Caywood
      • Orlando, Florida, États-Unis, 32803
        • Recrutement
        • AdventHealth Orlando
        • Contact:
        • Chercheur principal:
          • Fouad M. Hajjar
      • Pensacola, Florida, États-Unis, 32504
      • St. Petersburg, Florida, États-Unis, 33701
        • Recrutement
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Chercheur principal:
          • Jennifer B. Dean
      • Tampa, Florida, États-Unis, 33607
        • Recrutement
        • Saint Joseph's Hospital/Children's Hospital-Tampa
        • Contact:
        • Chercheur principal:
          • Don E. Eslin
      • West Palm Beach, Florida, États-Unis, 33407
        • Recrutement
        • Saint Mary's Medical Center
        • Chercheur principal:
          • Matthew D. Ramirez
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 561-822-4745
    • Georgia
      • Atlanta, Georgia, États-Unis, 30329
        • Recrutement
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Contact:
        • Chercheur principal:
          • Lauren Raney
      • Augusta, Georgia, États-Unis, 30912
        • Recrutement
        • Augusta University Medical Center
        • Contact:
        • Chercheur principal:
          • Colleen H. McDonough
      • Macon, Georgia, États-Unis, 31201
        • Recrutement
        • Atrium Health Navicent
        • Chercheur principal:
          • Sushmita Nair
        • Contact:
      • Savannah, Georgia, États-Unis, 31404
        • Recrutement
        • Memorial Health University Medical Center
        • Contact:
        • Chercheur principal:
          • James N. Yarnall
    • Hawaii
      • Honolulu, Hawaii, États-Unis, 96826
        • Recrutement
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 808-983-6090
        • Chercheur principal:
          • Wade T. Kyono
    • Idaho
      • Boise, Idaho, États-Unis, 83712
        • Recrutement
        • Saint Luke's Cancer Institute - Boise
        • Chercheur principal:
          • Martha M. Pacheco
        • Contact:
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Lurie Children's Hospital-Chicago
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 773-880-4562
        • Chercheur principal:
          • Loretta S. Li
      • Chicago, Illinois, États-Unis, 60637
        • Recrutement
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Gabrielle Lapping-Carr
      • Chicago, Illinois, États-Unis, 60612
        • Recrutement
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 312-355-3046
        • Chercheur principal:
          • Dipti S. Dighe
      • Oak Lawn, Illinois, États-Unis, 60453
        • Recrutement
        • Advocate Children's Hospital-Oak Lawn
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 847-723-7570
        • Chercheur principal:
          • Rebecca E. McFall
      • Park Ridge, Illinois, États-Unis, 60068
      • Peoria, Illinois, États-Unis, 61637
      • Springfield, Illinois, États-Unis, 62702
        • Recrutement
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 217-545-7929
        • Chercheur principal:
          • Gregory P. Brandt
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Recrutement
        • Riley Hospital for Children
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-248-1199
        • Chercheur principal:
          • Sandeep Batra
      • Indianapolis, Indiana, États-Unis, 46260
        • Recrutement
        • Ascension Saint Vincent Indianapolis Hospital
        • Contact:
        • Chercheur principal:
          • Bassem I. Razzouk
    • Iowa
      • Des Moines, Iowa, États-Unis, 50309
        • Recrutement
        • Blank Children's Hospital
        • Contact:
        • Chercheur principal:
          • Samantha L. Mallory
      • Iowa City, Iowa, États-Unis, 52242
        • Recrutement
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-237-1225
        • Chercheur principal:
          • Andrew P. Groves
    • Kentucky
      • Lexington, Kentucky, États-Unis, 40536
        • Recrutement
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 859-257-3379
        • Chercheur principal:
          • James T. Badgett
      • Louisville, Kentucky, États-Unis, 40202
        • Recrutement
        • Norton Children's Hospital
        • Contact:
        • Chercheur principal:
          • Michael J. Ferguson
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70118
        • Recrutement
        • Children's Hospital New Orleans
        • Chercheur principal:
          • Maria C. Velez-Yanguas
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 504-894-5377
      • New Orleans, Louisiana, États-Unis, 70121
        • Recrutement
        • Ochsner Medical Center Jefferson
        • Contact:
        • Chercheur principal:
          • Craig Lotterman
    • Maine
      • Scarborough, Maine, États-Unis, 04074
        • Recrutement
        • Maine Children's Cancer Program
        • Chercheur principal:
          • Eric C. Larsen
        • Contact:
    • Maryland
      • Baltimore, Maryland, États-Unis, 21287
        • Recrutement
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Chercheur principal:
          • Stacy L. Cooper
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 410-955-8804
          • E-mail: jhcccro@jhmi.edu
      • Baltimore, Maryland, États-Unis, 21215
        • Recrutement
        • Sinai Hospital of Baltimore
        • Chercheur principal:
          • Jason M. Fixler
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 410-601-9083
      • Bethesda, Maryland, États-Unis, 20889-5600
        • Recrutement
        • Walter Reed National Military Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 301-319-2100
        • Chercheur principal:
          • Kip R. Hartman
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Dana-Farber Cancer Institute
        • Chercheur principal:
          • Melissa A. Burns
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 877-442-3324
      • Worcester, Massachusetts, États-Unis, 01655
        • Recrutement
        • UMass Memorial Medical Center - University Campus
        • Contact:
        • Chercheur principal:
          • Stefanie R. Lowas
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • Recrutement
        • C S Mott Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-865-1125
        • Chercheur principal:
          • Joshua W. Goldman
      • Detroit, Michigan, États-Unis, 48201
      • Grand Rapids, Michigan, États-Unis, 49503
        • Recrutement
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, États-Unis, 49007
        • Recrutement
        • Bronson Methodist Hospital
        • Contact:
        • Chercheur principal:
          • Kathleen Y. Butler
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55404
        • Recrutement
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
        • Chercheur principal:
          • Michael K. Richards
        • Contact:
      • Minneapolis, Minnesota, États-Unis, 55455
        • Recrutement
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 612-624-2620
        • Chercheur principal:
          • Peter M. Gordon
      • Rochester, Minnesota, États-Unis, 55905
        • Recrutement
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 855-776-0015
        • Chercheur principal:
          • Madeleine O'Keefe
    • Mississippi
      • Jackson, Mississippi, États-Unis, 39216
        • Recrutement
        • University of Mississippi Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 601-815-6700
        • Chercheur principal:
          • Amanda Strobel
    • Missouri
      • Kansas City, Missouri, États-Unis, 64108
        • Recrutement
        • Children's Mercy Hospitals and Clinics
        • Chercheur principal:
          • Keith J. August
        • Contact:
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University School of Medicine
        • Contact:
        • Chercheur principal:
          • Laura G. Schuettpelz
      • St Louis, Missouri, États-Unis, 63141
        • Recrutement
        • Mercy Hospital Saint Louis
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 314-251-7066
        • Chercheur principal:
          • Robin D. Hanson
    • Nebraska
      • Omaha, Nebraska, États-Unis, 68114
        • Recrutement
        • Children's Hospital and Medical Center of Omaha
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 402-955-3949
        • Chercheur principal:
          • Jill C. Beck
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89135
        • Recrutement
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Chercheur principal:
          • Joseph L. Lasky
    • New Hampshire
      • Lebanon, New Hampshire, États-Unis, 03756
        • Recrutement
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Chercheur principal:
          • Angela Ricci
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, États-Unis, 07601
        • Recrutement
        • Hackensack University Medical Center
        • Chercheur principal:
          • Jing Chen
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 551-996-2897
      • Morristown, New Jersey, États-Unis, 07960
        • Recrutement
        • Morristown Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 973-971-5900
        • Chercheur principal:
          • Kathryn L. Laurie
      • Neptune City, New Jersey, États-Unis, 07753
        • Recrutement
        • Jersey Shore Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 732-776-4240
        • Chercheur principal:
          • Jing Chen
      • New Brunswick, New Jersey, États-Unis, 08903
        • Recrutement
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
        • Chercheur principal:
          • Marissa Botwinick
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 732-235-8675
      • Paterson, New Jersey, États-Unis, 07503
        • Recrutement
        • Saint Joseph's Regional Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 973-754-2207
          • E-mail: HallL@sjhmc.org
        • Chercheur principal:
          • Alissa Kahn
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87106
        • Recrutement
        • University of New Mexico Cancer Center
        • Contact:
        • Chercheur principal:
          • Jessica M. Valdez
      • Albuquerque, New Mexico, États-Unis, 87106
        • Recrutement
        • Presbyterian Hospital
        • Chercheur principal:
          • Beeling Armijo
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 505-559-6113
          • E-mail: wburman@phs.org
    • New York
      • Albany, New York, États-Unis, 12208
        • Recrutement
        • Albany Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 518-262-5513
        • Chercheur principal:
          • Lauren R. Weintraub
      • Buffalo, New York, États-Unis, 14263
        • Recrutement
        • Roswell Park Cancer Institute
        • Contact:
        • Chercheur principal:
          • Lisa Niswander
      • Mineola, New York, États-Unis, 11501
        • Recrutement
        • NYU Langone Hospital - Long Island
        • Contact:
        • Chercheur principal:
          • Chana L. Glasser
      • New Hyde Park, New York, États-Unis, 11040
        • Recrutement
        • The Steven and Alexandra Cohen Children's Medical Center of New York
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 718-470-3460
        • Chercheur principal:
          • Hiren Patel
      • New York, New York, États-Unis, 10032
        • Recrutement
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Chercheur principal:
          • Lewis B. Silverman
        • Contact:
      • New York, New York, États-Unis, 10065
        • Recrutement
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 212-639-7592
        • Chercheur principal:
          • Kavitha Ramaswamy
      • New York, New York, États-Unis, 10016
        • Recrutement
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Chercheur principal:
          • Elizabeth A. Raetz
        • Contact:
      • New York, New York, États-Unis, 10065
        • Recrutement
        • NYP/Weill Cornell Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 212-746-1848
        • Chercheur principal:
          • Jaclyn Rosenzweig
      • Stony Brook, New York, États-Unis, 11794
        • Recrutement
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-862-2215
        • Chercheur principal:
          • Laura E. Hogan
      • Syracuse, New York, États-Unis, 13210
        • Recrutement
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 315-464-5476
        • Chercheur principal:
          • Melanie A. Comito
      • The Bronx, New York, États-Unis, 10467
        • Recrutement
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Chercheur principal:
          • Alice Lee
      • Valhalla, New York, États-Unis, 10595
        • Recrutement
        • New York Medical College
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 914-594-3794
        • Chercheur principal:
          • Andrew J. Bellantoni
    • North Carolina
      • Asheville, North Carolina, États-Unis, 28801
      • Chapel Hill, North Carolina, États-Unis, 27599
        • Recrutement
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Thomas B. Alexander
      • Charlotte, North Carolina, États-Unis, 28203
        • Recrutement
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-804-9376
        • Chercheur principal:
          • Joel A. Kaplan
      • Durham, North Carolina, États-Unis, 27710
        • Recrutement
        • Duke University Medical Center
        • Chercheur principal:
          • Jessica M. Sun
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 888-275-3853
      • Winston-Salem, North Carolina, États-Unis, 27157
        • Recrutement
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 336-713-6771
        • Chercheur principal:
          • Sarah Supples
    • North Dakota
      • Fargo, North Dakota, États-Unis, 58122
    • Ohio
      • Akron, Ohio, États-Unis, 44308
        • Recrutement
        • Children's Hospital Medical Center of Akron
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 330-543-3193
        • Chercheur principal:
          • Lauren R. Draper
      • Cincinnati, Ohio, États-Unis, 45229
        • Recrutement
        • Cincinnati Children's Hospital Medical Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 513-636-2799
          • E-mail: cancer@cchmc.org
        • Chercheur principal:
          • Erin H. Breese
      • Cleveland, Ohio, États-Unis, 44106
        • Recrutement
        • Rainbow Babies and Childrens Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 216-844-5437
        • Chercheur principal:
          • Duncan S. Stearns
      • Columbus, Ohio, États-Unis, 43205
        • Recrutement
        • Nationwide Children's Hospital
        • Contact:
        • Chercheur principal:
          • Mark A. Ranalli
      • Dayton, Ohio, États-Unis, 45404
        • Recrutement
        • Dayton Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-228-4055
        • Chercheur principal:
          • Jordan M. Wright
      • Toledo, Ohio, États-Unis, 43606
        • Recrutement
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
        • Contact:
        • Chercheur principal:
          • Jamie L. Dargart
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • Recrutement
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Chercheur principal:
          • Rene Y. McNall-Knapp
    • Pennsylvania
      • Allentown, Pennsylvania, États-Unis, 18103
        • Recrutement
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Chercheur principal:
          • Jacob A. Troutman
      • Hershey, Pennsylvania, États-Unis, 17033
        • Recrutement
        • Penn State Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 717-531-6012
        • Chercheur principal:
          • Lisa M. McGregor
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Recrutement
        • Children's Hospital of Philadelphia
        • Chercheur principal:
          • Sarah K. Tasian
        • Contact:
      • Philadelphia, Pennsylvania, États-Unis, 19134
        • Recrutement
        • Saint Christopher's Hospital for Children
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 215-427-8991
        • Chercheur principal:
          • Gregory E. Halligan
      • Pittsburgh, Pennsylvania, États-Unis, 15224
        • Recrutement
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Chercheur principal:
          • Colleen Mathews
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • Recrutement
        • Rhode Island Hospital
        • Chercheur principal:
          • Bradley DeNardo
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 401-444-1488
    • South Carolina
      • Columbia, South Carolina, États-Unis, 29203
        • Recrutement
        • Prisma Health Richland Hospital
        • Chercheur principal:
          • Stuart L. Cramer
        • Contact:
      • Greenville, South Carolina, États-Unis, 29605
        • Recrutement
        • BI-LO Charities Children's Cancer Center
        • Chercheur principal:
          • Aniket Saha
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, États-Unis, 57117-5134
        • Recrutement
        • Sanford USD Medical Center - Sioux Falls
        • Contact:
        • Chercheur principal:
          • Jordan Fritch-Hanson
    • Tennessee
      • Knoxville, Tennessee, États-Unis, 37916
        • Recrutement
        • East Tennessee Childrens Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 865-541-8266
        • Chercheur principal:
          • Susan E. Spiller
      • Nashville, Tennessee, États-Unis, 37232
        • Recrutement
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 800-811-8480
        • Chercheur principal:
          • Brianna N. Smith
      • Nashville, Tennessee, États-Unis, 37203
        • Recrutement
        • The Children's Hospital at TriStar Centennial
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 615-342-1919
        • Chercheur principal:
          • Clinton M. Carroll
    • Texas
      • Austin, Texas, États-Unis, 78723
        • Recrutement
        • Dell Children's Medical Center of Central Texas
        • Contact:
        • Chercheur principal:
          • Shannon M. Cohn
      • Corpus Christi, Texas, États-Unis, 78411
        • Recrutement
        • Driscoll Children's Hospital
        • Contact:
        • Chercheur principal:
          • Nkechi I. Mba
      • Dallas, Texas, États-Unis, 75390
        • Recrutement
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Chercheur principal:
          • Tamra L. Slone
      • Dallas, Texas, États-Unis, 75230
        • Recrutement
        • Medical City Dallas Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 972-566-5588
        • Chercheur principal:
          • Maurizio L. Ghisoli
      • El Paso, Texas, États-Unis, 79905
        • Recrutement
        • El Paso Children's Hospital
        • Contact:
        • Chercheur principal:
          • Benjamin Carcamo
      • Fort Worth, Texas, États-Unis, 76104
        • Recrutement
        • Cook Children's Medical Center
        • Contact:
        • Chercheur principal:
          • Kenneth M. Heym
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 713-798-1354
          • E-mail: burton@bcm.edu
        • Chercheur principal:
          • Chelsea Vrana
      • Lubbock, Texas, États-Unis, 79410
        • Recrutement
        • Covenant Children's Hospital
        • Chercheur principal:
          • Kishor M. Bhende
        • Contact:
      • Lubbock, Texas, États-Unis, 79415
        • Recrutement
        • UMC Cancer Center / UMC Health System
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 806-775-8590
        • Chercheur principal:
          • Erin K. Barr
      • San Antonio, Texas, États-Unis, 78207
        • Recrutement
        • Children's Hospital of San Antonio
        • Contact:
        • Chercheur principal:
          • Julie Voeller
      • San Antonio, Texas, États-Unis, 78229
        • Recrutement
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Chercheur principal:
          • Anne-Marie R. Langevin
      • San Antonio, Texas, États-Unis, 78229
        • Recrutement
        • Methodist Children's Hospital of South Texas
        • Contact:
        • Chercheur principal:
          • Jose M. Esquilin
      • Temple, Texas, États-Unis, 76508
        • Recrutement
        • Scott and White Memorial Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 254-724-5407
        • Chercheur principal:
          • Nicholas W. McGregor
    • Utah
      • Salt Lake City, Utah, États-Unis, 84113
        • Recrutement
        • Primary Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 801-585-5270
        • Chercheur principal:
          • David S. Mangum
    • Vermont
      • Burlington, Vermont, États-Unis, 05405
        • Recrutement
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 802-656-8990
          • E-mail: rpo@uvm.edu
        • Chercheur principal:
          • Jessica L. Heath
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22908
        • Recrutement
        • University of Virginia Cancer Center
        • Contact:
        • Chercheur principal:
          • Brian C. Belyea
      • Falls Church, Virginia, États-Unis, 22042
        • Recrutement
        • Inova Fairfax Hospital
        • Contact:
        • Chercheur principal:
          • Robin Y. Dulman
      • Norfolk, Virginia, États-Unis, 23507
        • Recrutement
        • Children's Hospital of The King's Daughters
        • Contact:
        • Chercheur principal:
          • Melissa S. Mark
      • Richmond, Virginia, États-Unis, 23298
        • Recrutement
        • VCU Massey Comprehensive Cancer Center
        • Chercheur principal:
          • Jordyn R. Griffin
        • Contact:
      • Roanoke, Virginia, États-Unis, 24014
        • Recrutement
        • Carilion Children's
        • Contact:
        • Chercheur principal:
          • Erwood G. Edwards
    • Washington
      • Seattle, Washington, États-Unis, 98105
        • Recrutement
        • Seattle Children's Hospital
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 866-987-2000
        • Chercheur principal:
          • Sarah E. Leary
      • Spokane, Washington, États-Unis, 99204
        • Recrutement
        • Providence Sacred Heart Medical Center and Children's Hospital
        • Contact:
        • Chercheur principal:
          • Judy L. Felgenhauer
      • Tacoma, Washington, États-Unis, 98405
        • Recrutement
        • Mary Bridge Children's Hospital and Health Center
        • Contact:
        • Chercheur principal:
          • Robert G. Irwin
    • Wisconsin
      • Green Bay, Wisconsin, États-Unis, 54301
        • Recrutement
        • Saint Vincent Hospital Cancer Center Green Bay
        • Chercheur principal:
          • Catherine A. Long
        • Contact:
      • Madison, Wisconsin, États-Unis, 53792
        • Recrutement
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Contact:
        • Chercheur principal:
          • Cathy A. Lee-Miller
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Recrutement
        • Children's Hospital of Wisconsin
        • Contact:
          • Site Public Contact
          • Numéro de téléphone: 414-955-4727
          • E-mail: MACCCTO@mcw.edu
        • Chercheur principal:
          • Paul D. Harker-Murray

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an à 46 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients must be > 365 days and < 18 years (for AIEOP-BFM), > 365 days and < 22 years (for Children's Oncology Group [COG]) and > 365 days and < 46 years (for ALLTogether sites) at the time of enrollment

  • Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB

  • Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment

  • Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy

  • Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine

  • Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)

  • Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL

  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age

  • For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):

    • Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
    • Measured GFR ≥ 50 mL/min/1.73 m^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard

  • For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight

  • Direct bilirubin < 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)

  • * Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) OR

    • Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary]) AND

    • Corrected QT Interval, QTc < 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy [repeat if necessary])

      • Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment

Exclusion Criteria:

  • Known history of chronic myeloid leukemia (CML)

  • ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase

  • ALL developing after a previous cancer treated with cytotoxic chemotherapy

  • Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation

  • Down syndrome (trisomy 21)

  • Pregnancy and breast feeding

    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment

    • Lactating females who plan to breastfeed their infants

    • Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol

      • NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer

  • Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib

  • Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block

  • Patients with known Charcot-Marie-Tooth disease

  • Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement

    • Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved

  • HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Stratum I (Ph+ ALL)

See detailed description
Procédure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Autres noms:
  • Biopsie de la moelle osseuse
  • Biopsie, Moelle Osseuse
Procédure: Echocardiography Test

Undergo ECHO

Autres noms:
  • Échocardiographie
  • CE
Procédure: Multigated Acquisition Scan

Undergo MUGA

Autres noms:
  • Balayage du bassin sanguin
  • Angiographie à l'équilibre des radionucléides
  • Imagerie du pool sanguin contrôlé
  • MUGA
  • Ventriculographie des radionucléides
  • RNVG
  • Numérisation SYMA
  • Numérisation d'acquisition synchronisée à plusieurs portes
  • Numérisation MUGA
  • Balayage d'acquisition multi-portes
  • Balayage du ventriculogramme radionucléide
  • Balayage du pool cardiaque contrôlé
  • Analyse RNV
Procédure: Biospecimen Collection

Undergo blood and CSF sample collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Biologique: Blinatumomab

Receive IV

Autres noms:
  • Blincyto
  • Anticorps Monoclonal Bispécifique Anti-CD19 x Anti-CD3
  • Anticorps Monoclonal Bispécifique Recombinant Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MÉDI538
  • AMG-103
  • MÉDI 538
Médicament: Calaspargase Pegol

Receive IV

Autres noms:
  • Asparaginase (Isoenzyme II d'Escherichia coli), Conjugué avec alpha-(((2,5-dioxo-1-pyrrolidinyl)oxy)carbonyl)-oméga-méthoxypoly(oxy-1,2-éthanediyle)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-Asparaginase
  • Succinimidyl Carbonate Monométhoxypolyéthylène Glycol E. coli L-Asparaginase
  • Calaspargase Pegol-mknl
Médicament: Cyclophosphamide

Receive IV

Autres noms:
  • Cytoxane
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroéthyl)amino]tétrahydro-, 2-oxyde, monohydraté
  • Carloxane
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafène
  • Clapène
  • CP monohydraté
  • CYCLO-cellule
  • Cycloblastine
  • Cyclophosphame
  • Cyclophosphamide monohydraté
  • Monohydrate de cyclophosphamide
  • Cyclophosphamide
  • Cyclophosphane
  • Cyclostine
  • Cytophosphane
  • Fosfaséron
  • Genoxal
  • Genuxal
  • Lédoxine
  • Mitoxane
  • Néosar
  • Revimmuniser
  • Syklofosfamide
  • WR-138719
  • Asta B 518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Médicament: Cytarabine

Receive IV or subcutaneously

Autres noms:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Bêta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Bêta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-pyrimidinone, 4-amino-1-bêta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexandre
  • Ara-C
  • Cellule ARA
  • Arabe
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytine
  • Bêta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-bêta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PSF
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Médicament: Dasatinib

Receive PO

Autres noms:
  • BMS-354825
  • Hydrate de dasatinib
  • Monohydrate de dasatinib
  • Sprycel®
  • BMS 354825
  • BMS354825
Médicament: Daunorubicin

Receive IV

Autres noms:
  • DNR
  • Rubidomycine
  • Daunomycine
  • Daunorrubicina
  • Leucémomycine C
  • Rubomycine C
Médicament: Doxorubicin

Receive IV

Autres noms:
  • Adriablastine
  • Hydroxydaunomycine
  • Hydroxyl Daunorubicine
  • Hydroxyldaunorubicine
Médicament: Leucovorin

Receive PO or IV

Autres noms:
  • Acide folinique
Médicament: Mercaptopurine

Receive PO

Autres noms:
  • 6 MP
  • Purinethol
  • 3H-Purine-6-thiol
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-mercaptopurine monohydratée
  • 6-Purinethiol
  • 6-thiopurine
  • 6-thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-mercapto-1,3,4,6-tétrazaïndène
  • Alti-Mercaptopurine
  • Azathiopurine
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leucérine
  • Leupurine
  • Mercaleukim
  • Mercaleukin
  • Mercaptine
  • Mercaptopurine
  • Mercapurine
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Puriméthol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydraté
  • Purinethiol
  • U-4748
  • WR-2785
Médicament: Methotrexate

Receive IT or IV or PO

Autres noms:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-méthoptérine
  • Améthoptérine
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emméthate
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Lédertrexate
  • Lumexon
  • Maxtrex
  • Mésatrexate
  • Métex
  • Méthoblastine
  • Méthotrexate LPF
  • Méthotrexate Méthylaminoptérine
  • Méthotrexatum
  • Métotrexato
  • Métrotex
  • Mexate-AQ
  • Novatrex
  • Rhumatrex
  • Textate
  • Tremetex
  • Trexéron
  • Trixilem
  • WR-19039
  • Jylamvo
Médicament: Pegaspargase

Receive IV or intramuscularly

Autres noms:
  • L-Asparaginase avec Polyéthylène Glycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyéthylène Glycol L-Asparaginase
  • Polyéthylène Glycol-L-Asparaginase
Médicament: Prednisolone

Receive PO

Autres noms:
  • (11beta)-11,17,21-Trihydroxyprégna-1,4-diène-3,20-dione
  • .delta.1-hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoïde
  • Cortalone
  • Cortisone
  • Dacortine H
  • Décaprednil
  • Décortine H
  • Delta(1)Hydrocortisone
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-phoricol
  • Delta1-déhydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortine H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lénisolone
  • Lépi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprédnil
  • Métacortandralone
  • Meti Derm
  • Méticortelone
  • Opredsone
  • Panafcortelone
  • Précortisyl
  • Préd-Clysma
  • Prédeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prélone
  • Prénilone
  • Stérane
Médicament: Prednisone

Receive PO

Autres noms:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Déhydrocortisone
  • Adasone
  • Cortancyl
  • Dacortine
  • DeCortin
  • Décortisyl
  • Décorton
  • Delta 1-Cortisone
  • Delta-Dôme
  • Deltacortène
  • Deltacortisone
  • Deltadéhydrocortisone
  • Deltison
  • Delta
  • Éconosone
  • Lisacort
  • Méprosona-F
  • Métacortandracine
  • Méticorten
  • Ofisolone
  • Panafort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Prédicteur
  • Prédiction
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Prédilection
  • Intensol de prednisone
  • Prednison
  • Prednitone
  • Promifène
  • Rayos
  • Servison
  • SK-Prednisone
Médicament: Vincristine

Receive IV

Autres noms:
  • Magnétoscope
  • Leurocristine
  • Vincristine
  • LCR
Expérimental: Stratum II (PDGFRB ABL-Class fusions)

See detailed description.
Procédure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Autres noms:
  • Biopsie de la moelle osseuse
  • Biopsie, Moelle Osseuse
Procédure: Echocardiography Test

Undergo ECHO

Autres noms:
  • Échocardiographie
  • CE
Procédure: Multigated Acquisition Scan

Undergo MUGA

Autres noms:
  • Balayage du bassin sanguin
  • Angiographie à l'équilibre des radionucléides
  • Imagerie du pool sanguin contrôlé
  • MUGA
  • Ventriculographie des radionucléides
  • RNVG
  • Numérisation SYMA
  • Numérisation d'acquisition synchronisée à plusieurs portes
  • Numérisation MUGA
  • Balayage d'acquisition multi-portes
  • Balayage du ventriculogramme radionucléide
  • Balayage du pool cardiaque contrôlé
  • Analyse RNV
Radiation: Radiation Therapy

Undergo radiation therapy

Autres noms:
  • Radiothérapie du cancer
  • ENERGY_TYPE
  • Irradier
  • Irradié
  • Irradiation
  • Radiation
  • Radiothérapie, SAI
  • Radiothérapie
  • RT
  • Thérapie, Radiation
  • Type d'énergie
Procédure: Biospecimen Collection

Undergo blood and CSF sample collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Biologique: Blinatumomab

Receive IV

Autres noms:
  • Blincyto
  • Anticorps Monoclonal Bispécifique Anti-CD19 x Anti-CD3
  • Anticorps Monoclonal Bispécifique Recombinant Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MÉDI538
  • AMG-103
  • MÉDI 538
Médicament: Calaspargase Pegol

Receive IV

Autres noms:
  • Asparaginase (Isoenzyme II d'Escherichia coli), Conjugué avec alpha-(((2,5-dioxo-1-pyrrolidinyl)oxy)carbonyl)-oméga-méthoxypoly(oxy-1,2-éthanediyle)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-Asparaginase
  • Succinimidyl Carbonate Monométhoxypolyéthylène Glycol E. coli L-Asparaginase
  • Calaspargase Pegol-mknl
Médicament: Cyclophosphamide

Receive IV

Autres noms:
  • Cytoxane
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroéthyl)amino]tétrahydro-, 2-oxyde, monohydraté
  • Carloxane
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafène
  • Clapène
  • CP monohydraté
  • CYCLO-cellule
  • Cycloblastine
  • Cyclophosphame
  • Cyclophosphamide monohydraté
  • Monohydrate de cyclophosphamide
  • Cyclophosphamide
  • Cyclophosphane
  • Cyclostine
  • Cytophosphane
  • Fosfaséron
  • Genoxal
  • Genuxal
  • Lédoxine
  • Mitoxane
  • Néosar
  • Revimmuniser
  • Syklofosfamide
  • WR-138719
  • Asta B 518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Médicament: Cytarabine

Receive IV or subcutaneously

Autres noms:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Bêta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Bêta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-pyrimidinone, 4-amino-1-bêta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexandre
  • Ara-C
  • Cellule ARA
  • Arabe
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytine
  • Bêta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-bêta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PSF
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Médicament: Daunorubicin

Receive IV

Autres noms:
  • DNR
  • Rubidomycine
  • Daunomycine
  • Daunorrubicina
  • Leucémomycine C
  • Rubomycine C
Médicament: Doxorubicin

Receive IV

Autres noms:
  • Adriablastine
  • Hydroxydaunomycine
  • Hydroxyl Daunorubicine
  • Hydroxyldaunorubicine
Médicament: Leucovorin

Receive PO or IV

Autres noms:
  • Acide folinique
Médicament: Mercaptopurine

Receive PO

Autres noms:
  • 6 MP
  • Purinethol
  • 3H-Purine-6-thiol
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-mercaptopurine monohydratée
  • 6-Purinethiol
  • 6-thiopurine
  • 6-thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-mercapto-1,3,4,6-tétrazaïndène
  • Alti-Mercaptopurine
  • Azathiopurine
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leucérine
  • Leupurine
  • Mercaleukim
  • Mercaleukin
  • Mercaptine
  • Mercaptopurine
  • Mercapurine
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Puriméthol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydraté
  • Purinethiol
  • U-4748
  • WR-2785
Médicament: Methotrexate

Receive IT or IV or PO

Autres noms:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-méthoptérine
  • Améthoptérine
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emméthate
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Lédertrexate
  • Lumexon
  • Maxtrex
  • Mésatrexate
  • Métex
  • Méthoblastine
  • Méthotrexate LPF
  • Méthotrexate Méthylaminoptérine
  • Méthotrexatum
  • Métotrexato
  • Métrotex
  • Mexate-AQ
  • Novatrex
  • Rhumatrex
  • Textate
  • Tremetex
  • Trexéron
  • Trixilem
  • WR-19039
  • Jylamvo
Médicament: Pegaspargase

Receive IV or intramuscularly

Autres noms:
  • L-Asparaginase avec Polyéthylène Glycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyéthylène Glycol L-Asparaginase
  • Polyéthylène Glycol-L-Asparaginase
Médicament: Prednisolone

Receive PO

Autres noms:
  • (11beta)-11,17,21-Trihydroxyprégna-1,4-diène-3,20-dione
  • .delta.1-hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoïde
  • Cortalone
  • Cortisone
  • Dacortine H
  • Décaprednil
  • Décortine H
  • Delta(1)Hydrocortisone
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-phoricol
  • Delta1-déhydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortine H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lénisolone
  • Lépi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprédnil
  • Métacortandralone
  • Meti Derm
  • Méticortelone
  • Opredsone
  • Panafcortelone
  • Précortisyl
  • Préd-Clysma
  • Prédeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prélone
  • Prénilone
  • Stérane
Médicament: Prednisone

Receive PO

Autres noms:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Déhydrocortisone
  • Adasone
  • Cortancyl
  • Dacortine
  • DeCortin
  • Décortisyl
  • Décorton
  • Delta 1-Cortisone
  • Delta-Dôme
  • Deltacortène
  • Deltacortisone
  • Deltadéhydrocortisone
  • Deltison
  • Delta
  • Éconosone
  • Lisacort
  • Méprosona-F
  • Métacortandracine
  • Méticorten
  • Ofisolone
  • Panafort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Prédicteur
  • Prédiction
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Prédilection
  • Intensol de prednisone
  • Prednison
  • Prednitone
  • Promifène
  • Rayos
  • Servison
  • SK-Prednisone
Médicament: Vincristine

Receive IV

Autres noms:
  • Magnétoscope
  • Leurocristine
  • Vincristine
  • LCR
Médicament: Imatinib

Given PO

Médicament: Thioguanine

Receive PO

Autres noms:
  • 6-TG
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purine-6-thione
  • 2-Amino-6-mercaptopurine
  • 2-Amino-6-purinethiol
  • 2-aminopurine-6-thiol
  • 2-aminopurine-6(1H)-thione
  • Hémihydrate de 2-aminopurine-6-thiol
  • 2-mercapto-6-aminopurine
  • 6-Amino-2-mercaptopurine
  • 6-mercapto-2-aminopurine
  • 6-Mercaptoguanine
  • 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
  • BW 5071
  • Lanvis
  • Tabloïde
  • Hémihydrate de thioguanine
  • Hydrate de thioguanine
  • Tioguanine
  • Bienvenue U3B
  • WR-1141
  • X 27
Expérimental: Stratum III (non-PDGFRB ABL-Class fusions)

See detailed description.
Procédure: Bone Marrow Biopsy

Undergo bone marrow biopsy

Autres noms:
  • Biopsie de la moelle osseuse
  • Biopsie, Moelle Osseuse
Procédure: Echocardiography Test

Undergo ECHO

Autres noms:
  • Échocardiographie
  • CE
Procédure: Multigated Acquisition Scan

Undergo MUGA

Autres noms:
  • Balayage du bassin sanguin
  • Angiographie à l'équilibre des radionucléides
  • Imagerie du pool sanguin contrôlé
  • MUGA
  • Ventriculographie des radionucléides
  • RNVG
  • Numérisation SYMA
  • Numérisation d'acquisition synchronisée à plusieurs portes
  • Numérisation MUGA
  • Balayage d'acquisition multi-portes
  • Balayage du ventriculogramme radionucléide
  • Balayage du pool cardiaque contrôlé
  • Analyse RNV
Radiation: Radiation Therapy

Undergo radiation therapy

Autres noms:
  • Radiothérapie du cancer
  • ENERGY_TYPE
  • Irradier
  • Irradié
  • Irradiation
  • Radiation
  • Radiothérapie, SAI
  • Radiothérapie
  • RT
  • Thérapie, Radiation
  • Type d'énergie
Procédure: Biospecimen Collection

Undergo blood and CSF sample collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Biologique: Blinatumomab

Receive IV

Autres noms:
  • Blincyto
  • Anticorps Monoclonal Bispécifique Anti-CD19 x Anti-CD3
  • Anticorps Monoclonal Bispécifique Recombinant Anti-CD19/Anti-CD3 MT103
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MÉDI538
  • AMG-103
  • MÉDI 538
Médicament: Calaspargase Pegol

Receive IV

Autres noms:
  • Asparaginase (Isoenzyme II d'Escherichia coli), Conjugué avec alpha-(((2,5-dioxo-1-pyrrolidinyl)oxy)carbonyl)-oméga-méthoxypoly(oxy-1,2-éthanediyle)
  • Asparlas
  • EZN-2285
  • SC-PEG E. Coli L-Asparaginase
  • Succinimidyl Carbonate Monométhoxypolyéthylène Glycol E. coli L-Asparaginase
  • Calaspargase Pegol-mknl
Médicament: Cyclophosphamide

Receive IV

Autres noms:
  • Cytoxane
  • CTX
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroéthyl)amino]tétrahydro-, 2-oxyde, monohydraté
  • Carloxane
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafène
  • Clapène
  • CP monohydraté
  • CYCLO-cellule
  • Cycloblastine
  • Cyclophosphame
  • Cyclophosphamide monohydraté
  • Monohydrate de cyclophosphamide
  • Cyclophosphamide
  • Cyclophosphane
  • Cyclostine
  • Cytophosphane
  • Fosfaséron
  • Genoxal
  • Genuxal
  • Lédoxine
  • Mitoxane
  • Néosar
  • Revimmuniser
  • Syklofosfamide
  • WR-138719
  • Asta B 518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Médicament: Cytarabine

Receive IV or subcutaneously

Autres noms:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Bêta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Bêta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-pyrimidinone, 4-amino-1-bêta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexandre
  • Ara-C
  • Cellule ARA
  • Arabe
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytine
  • Bêta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-bêta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PSF
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Médicament: Dasatinib

Receive PO

Autres noms:
  • BMS-354825
  • Hydrate de dasatinib
  • Monohydrate de dasatinib
  • Sprycel®
  • BMS 354825
  • BMS354825
Médicament: Daunorubicin

Receive IV

Autres noms:
  • DNR
  • Rubidomycine
  • Daunomycine
  • Daunorrubicina
  • Leucémomycine C
  • Rubomycine C
Médicament: Doxorubicin

Receive IV

Autres noms:
  • Adriablastine
  • Hydroxydaunomycine
  • Hydroxyl Daunorubicine
  • Hydroxyldaunorubicine
Médicament: Leucovorin

Receive PO or IV

Autres noms:
  • Acide folinique
Médicament: Mercaptopurine

Receive PO

Autres noms:
  • 6 MP
  • Purinethol
  • 3H-Purine-6-thiol
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-mercaptopurine monohydratée
  • 6-Purinethiol
  • 6-thiopurine
  • 6-thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-mercapto-1,3,4,6-tétrazaïndène
  • Alti-Mercaptopurine
  • Azathiopurine
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leucérine
  • Leupurine
  • Mercaleukim
  • Mercaleukin
  • Mercaptine
  • Mercaptopurine
  • Mercapurine
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Puriméthol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydraté
  • Purinethiol
  • U-4748
  • WR-2785
Médicament: Methotrexate

Receive IT or IV or PO

Autres noms:
  • Abitrexate
  • Folex
  • Mexate
  • MTX
  • Alpha-méthoptérine
  • Améthoptérine
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emméthate
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Lédertrexate
  • Lumexon
  • Maxtrex
  • Mésatrexate
  • Métex
  • Méthoblastine
  • Méthotrexate LPF
  • Méthotrexate Méthylaminoptérine
  • Méthotrexatum
  • Métotrexato
  • Métrotex
  • Mexate-AQ
  • Novatrex
  • Rhumatrex
  • Textate
  • Tremetex
  • Trexéron
  • Trixilem
  • WR-19039
  • Jylamvo
Médicament: Pegaspargase

Receive IV or intramuscularly

Autres noms:
  • L-Asparaginase avec Polyéthylène Glycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyéthylène Glycol L-Asparaginase
  • Polyéthylène Glycol-L-Asparaginase
Médicament: Prednisolone

Receive PO

Autres noms:
  • (11beta)-11,17,21-Trihydroxyprégna-1,4-diène-3,20-dione
  • .delta.1-hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoïde
  • Cortalone
  • Cortisone
  • Dacortine H
  • Décaprednil
  • Décortine H
  • Delta(1)Hydrocortisone
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-phoricol
  • Delta1-déhydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortine H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lénisolone
  • Lépi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprédnil
  • Métacortandralone
  • Meti Derm
  • Méticortelone
  • Opredsone
  • Panafcortelone
  • Précortisyl
  • Préd-Clysma
  • Prédeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prélone
  • Prénilone
  • Stérane
Médicament: Prednisone

Receive PO

Autres noms:
  • Deltasone
  • Orasone
  • .delta.1-Cortisone
  • 1, 2-Déhydrocortisone
  • Adasone
  • Cortancyl
  • Dacortine
  • DeCortin
  • Décortisyl
  • Décorton
  • Delta 1-Cortisone
  • Delta-Dôme
  • Deltacortène
  • Deltacortisone
  • Deltadéhydrocortisone
  • Deltison
  • Delta
  • Éconosone
  • Lisacort
  • Méprosona-F
  • Métacortandracine
  • Méticorten
  • Ofisolone
  • Panafort
  • Panasol-S
  • Paracort
  • Perrigo Prednisone
  • PRED
  • Prédicteur
  • Prédiction
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Prédilection
  • Intensol de prednisone
  • Prednison
  • Prednitone
  • Promifène
  • Rayos
  • Servison
  • SK-Prednisone
Médicament: Vincristine

Receive IV

Autres noms:
  • Magnétoscope
  • Leurocristine
  • Vincristine
  • LCR
Médicament: Thioguanine

Receive PO

Autres noms:
  • 6-TG
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purine-6-thione
  • 2-Amino-6-mercaptopurine
  • 2-Amino-6-purinethiol
  • 2-aminopurine-6-thiol
  • 2-aminopurine-6(1H)-thione
  • Hémihydrate de 2-aminopurine-6-thiol
  • 2-mercapto-6-aminopurine
  • 6-Amino-2-mercaptopurine
  • 6-mercapto-2-aminopurine
  • 6-Mercaptoguanine
  • 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
  • BW 5071
  • Lanvis
  • Tabloïde
  • Hémihydrate de thioguanine
  • Hydrate de thioguanine
  • Tioguanine
  • Bienvenue U3B
  • WR-1141
  • X 27

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)
Délai: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years

Will be assessed in children, adolescents, and young adults <25 years old with newly-diagnosed Ph+ (BCR::ABL1-rearranged) B acute lymphoblastic leukemia (B-ALL) who are treated with a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous dasatinib. Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years
ABL-class Ph-like B-ALL 3-year event free survival (EFS)
Délai: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years

Will be assessed in children, adolescents, and young adults <25 years old with newly-diagnosed ABL-class Ph-like B-ALL who are treated with a modified BFM chemotherapy backbone that incorporates three cycles of blinatumomab without traditional consolidation chemotherapy in combination with continuous imatinib for those with PDGFRB gene fusions or dasatinib for those without PDGFRB gene fusions. Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years
Incidence of adverse events
Délai: Up to 3 years

Will assess the safety and toxicity profile (infections, mucositis, neurotoxicity, cytokine release syndrome, hypogammaglobulinemia, therapy delays > 14 days, and treatment-related mortality) for patients with Ph+ or ABL-class Ph-like B-ALL treated on this novel chemo-immunotherapy backbone with continuous tyrosine kinase inhibitor (TKI). Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
Up to 3 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
3-year overall survival (OS)
Délai: Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years

Will be assessed in patients with Ph+ and ABL-class Ph-like B-ALL, respectively. Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years
3-year EFS
Délai: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years

Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years
3-year disease free survival
Délai: Time from end of consolidation/blinatumomab block 2 (TP2) for early responders to first event (relapse, second malignancy, or death in complete remission) or last contact for those who are event-free, assessed up to 3 years

Will be estimated using the Kaplan-Meier method with standard errors of Peto.
Time from end of consolidation/blinatumomab block 2 (TP2) for early responders to first event (relapse, second malignancy, or death in complete remission) or last contact for those who are event-free, assessed up to 3 years
Cumulative incidence rates of relapse
Délai: Up to 3 years

Will be estimated using Gray's method.
Up to 3 years
Treatment related mortality
Délai: Up to 3 years

Will be estimated at the end of therapy.
Up to 3 years
OS of patients with ABL-class Ph-like B-ALL
Délai: Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years

Will be stratified by their underlying ABL-class fusion subtypes.
Time from enrollment to death from any cause or date of last contact for those who are alive, assessed up to 3 years
Rates of end of Consolidation (EOC)/timepoint 2 (TP2) minimal residual disease (MRD) negativity for patients with Ph+ B-ALL
Délai: From EOC to TP2

Defined as <1x10^-4 or <0.01% for patients with Ph+ B-ALL.
From EOC to TP2
Rates of EOC/TP2 MRD negativity for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes
Délai: From EOC to TP2

Defined as <1x10^-4 or <0.01% for patients with ABL-class Ph-like B-ALL collectively and based on their ABL-class fusion subtypes.
From EOC to TP2

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Rates of end of induction (EOI)/timepoint 1 (TP1) bone marrow MRD negativity with the introduction of dasatinib
Délai: From EOI to TP1

Defined as <1x10-4 or <0.01% with the introduction of the relevant TKI during Induction for patients with Ph+ B-ALL.
From EOI to TP1
Outcomes of patients with Ph+ and Ph-like ABL-class B-ALL who are removed from protocol therapy due to consolidation failure
Délai: Up to 3 years

Will be collected and described. A secondary analysis will also be conducted, examining the EFS of patients in both arms of the randomization using conventional definition of consolidation failure (EOC/TP2 MRD ≥ 1%).
Up to 3 years
Percentage of patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy and their outcomes
Délai: Up to 3 years

Will be collected and described.
Up to 3 years
Outcomes for patients with Ph+ and ABL-class Ph-like B-ALL who continue TKI beyond protocol-prescribed therapy
Délai: Up to 3 years

EFS will be estimated at 3 years.
Up to 3 years
Prognostic significance of MRD by next-generation sequencing (NGS) at end of induction and end of consolidation
Délai: Up to 3 years

Its association with outcomes will be explored.
Up to 3 years
Clinical characteristics and outcomes of patients with chronic myeloid leukemia-like biology
Délai: Up to 3 years

Will be summarized using descriptive statistics.
Up to 3 years
Immune function of Ph+ and ABL-class Ph-like B-ALL patients
Délai: Up to 3 years

Will be summarized using descriptive statistics.
Up to 3 years
TKI levels in the plasma and cerebrospinal fluid of children with Ph+ and ABL-class Ph-like B-ALL
Délai: Up to 3 years

Will be summarized using descriptive statistics.
Up to 3 years
Impact of TKIs and high-dose methotrexate interaction and identify clinical and biologic factors influencing methotrexate clearance
Délai: Up to 3 years

Will be assessed by summarizing frequencies observed of the same.
Up to 3 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Thai Hoa Tran, Children's Oncology Group

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 mai 2025

Achèvement primaire (Estimé)

1 décembre 2030

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

8 novembre 2023

Première soumission répondant aux critères de contrôle qualité

8 novembre 2023

Première publication (Réel)

9 novembre 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 octobre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2023-09214
  • U10CA180886 (Subvention/contrat des NIH des États-Unis)
  • NCI-2023-09214 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • AALL2131 (Autre identifiant: CTEP)
  • AALL2131 (Autre identifiant: Children's Oncology Group)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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