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

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).

Trial Details

NCT ID
NCT06051409
Phase
PHASE3
Sponsor
Ascentage Pharma Group Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Olverembatinib
  • Investigator's choice of TKI
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility Criteria

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
  • Expected survival of at least 3 months
  • Adequate organ function

For full eligibility, visit ClinicalTrials.gov.

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