Phase 2 Study of Chemotherapy with Dasatinib or Imatinib and Blinatumomab for Children, Adolescents, and Young Adults with Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

What this Trial Is About

This trial studies children, adolescents, and young adults with Philadelphia chromosome positive Ph or ABL-class Philadelphia chromosome-like Ph-like B-cell acute lymphoblastic leukemia B-ALL. It evaluates the combination of blinatumomab with dasatinib or imatinib alongside standard chemotherapy. The study aims to estimate 3-year event-free survival and overall survival, describe safety and toxicity, and explore treatment responses and immune function in these patients. Participants receive a modified chemotherapy regimen including multiple cycles of blinatumomab without traditional consolidation chemotherapy combined with continuous tyrosine kinase inhibitors dasatinib or imatinib depending on fusion subtype. Treatment includes induction phases, blinatumomab blocks, interim maintenance, delayed intensification, and maintenance cycles over two years, with various drugs administered orally, intravenously, or intrathecally. Radiation therapy may be given in some cases. Throughout the study, participants undergo blood and cerebrospinal fluid sample collection, bone marrow biopsies, and heart function tests such as echocardiography or multigated acquisition scans. Researchers monitor minimal residual disease, treatment-related side effects, and long-term outcomes up to three years. The study involves regular assessments to evaluate treatment effectiveness and safety over the full duration of therapy.

A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)