drugset / Trial / NCT06051409

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

NCT06051409

RandomizedParallel-groupOpen-labelTreatment

Summary

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).

Timeline

Start
2023-08-31
Primary completion
2027-12-31
Completion
2029-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Olverembatinib Small molecule Oral