Clinical Trial

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

Recruiting Phase 3
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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).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-09-17; most recent amendment 2026-04-24.
Status change: Not Yet Recruiting → Recruiting 2023-09-22
Trial Details
NCT Number NCT06051409
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Guangzhou Healthquest Pharma Co., Ltd
Conditions Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Enrollment 350 participants
Start Date 2023-08-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-30