Phase 1 Study of ABL001 Combined With Dasatinib, Prednisone, and Blinatumomab for Adults With BCR-ABL Positive B-cell Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia in Lymphoid Blast Crisis

What this Trial Is About

Researchers are evaluating a drug called ABL001 combined with dasatinib Sprycel4 and prednisone, along with blinatumomab, as a possible treatment for adults with B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia in lymphoid blast crisis. This is a Phase I clinical trial aimed at testing the safety of ABL001 and determining the appropriate dose when used with these other drugs. Biomarker testing from blood and bone marrow samples will be included to better understand how the drug may work. Participants will receive all three drugs ABL001 taken orally daily, dasatinib taken orally once a day per cycle, and prednisone taken orally once a day with tapering and stopping during the second cycle. Blinatumomab will be given by intravenous continuous infusion starting no earlier than the first day of cycle 2 through cycle 6, each cycle lasting 42 days, totaling five cycles. Dose escalation follows a standard scheme to find the recommended dose for future studies. During the study, participants will have blood and bone marrow samples collected to assess biomarkers and evaluate the cancer. Researchers will monitor safety and measure outcomes such as the maximum tolerated dose of ABL001 within 42 days and various remission and response rates at 28, 56, and 85 days. The study involves close monitoring of organ function and patient health throughout treatment, with the overall participation timeline depending on individual treatment cycles and responses.

ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML