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
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
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.
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.