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AALL2131- An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia

1) 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) hemotherapy backbone that incorporates three cycles of blinatumomab

2) 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 TKI.

Protocol Number: 112510
Phase: Phase II/III
Applicable Disease Sites: Leukemia, other
Drugs Involved: Blinatumomab (AMG103)
Dasatinib (BMS-354825)
IMATINIB MESYLATE
Principal Investigator: Marissa Botwinick
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Newark Beth Israel Medical Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.