Phase 3 Study Comparing Olverembatinib Plus Chemotherapy to Investigators Choice of Tyrosine Kinase Inhibitor Plus Chemotherapy in Adults With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of olverembatinib combined with chemotherapy compared to an investigators choice of tyrosine kinase inhibitor TKI combined with chemotherapy in adults newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Ph ALL. This global, randomized, open-label Phase 3 study aims to provide important information about treatment options for this specific type of leukemia. Participants will receive either olverembatinib taken orally every other day along with chemotherapy, or a TKI chosen by the investigator taken orally once daily with chemotherapy. The study includes two groups one receiving the experimental olverembatinib combination and the other receiving the control treatment with investigator-selected TKI. Treatment cycles last 28 days, and the study follows participants through multiple cycles. During the study, participants will be monitored for their response to treatment by checking minimal residual disease negative complete remission rates during the first three cycles. Researchers will also assess event-free survival for up to 3 to 6 years, treatment-related side effects, drug levels in the blood, and quality of life related to leukemia. Safety assessments and other evaluations will continue through approximately two years of study participation, allowing for long-term monitoring of treatment effects and participant health.

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)