Study of Olverembatinib (HQP1351) in Patients With CML-CP

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B). Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

Trial Details

NCT ID
NCT06423911
Phase
PHASE3
Sponsor
Ascentage Pharma Group Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • olverembatinib
  • Bosutinib
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • Patients eligible for inclusion in this study must meet all of the following criteria:
  • Age ≥ 18 years old
  • Diagnosis of CML-CP
  • Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved T…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →