Open Actively Recruiting

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

About

Brief Summary

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
99 Years

Inclusion 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
  • Written informed consent obtained prior to any screening procedures.
  • Patients with adequate organ functions

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria.

  • For Part A only: T315I mutation at any time prior to starting study treatment.
  • Active infection that requires systemic drug therapy
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
  • Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
  • Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
  • Pregnant or nursing (lactating) women.
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Study Stats
Protocol No.
25-1078
Category
Leukemia
Contact
Vladimir Kustanovich
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06423911
For detailed technical eligibility, visit ClinicalTrials.gov.