drugset / Trial / NCT06051409
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Phase 3
Recruiting
350 enrolled
Ascentage Pharma Group Inc.
Guangzhou Healthquest Pharma Co., Ltd · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olverembatinib | Small molecule | — | Oral |