Phase II Study of Blinatumomab, Methotrexate, Cytarabine, and Ponatinib to Treat Adults with Philadelphia Chromosome-Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating how well a combination of blinatumomab, methotrexate, cytarabine, and ponatinib works in treating patients with Philadelphia chromosome Ph-positive, BCR-ABL positive, or relapsedrefractory acute lymphoblastic leukemia ALL. This phase II study aims to measure complete molecular response rates, overall response rates, relapse-free survival, event-free survival, and overall survival in these patients. The study also explores genetic factors and immune cell changes related to treatment outcomes. Participants receive blinatumomab intravenously nonstop on days 1-28 of cycles 1 through 5. Methotrexate and cytarabine are given intrathecally by spinal tap on days 1, 15, and 29 of cycles 1 through 4. Ponatinib is taken orally every day. Each treatment cycle lasts 6 weeks, and treatment continues unless the disease worsens or side effects become unacceptable. During the study, patients will have regular assessments including blood tests and molecular evaluations to track leukemia response and detect minimal residual disease. Follow-up visits occur 30 days after treatment ends and then every 6 months to monitor long-term outcomes and safety. The study monitors event-free survival and overall survival for up to 6 years after treatment begins, ensuring thorough evaluation of the treatment effects over time.

Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia