Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Keywords

Chronic Myeloid Leukemia, CML, CML, Chronic Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase, olverembatinib, bosutinib

Eligibility

You can join if…

Open to people ages 18 years and up

Patients eligible for inclusion in this study must meet all of the following criteria:

  1. Age ≥ 18 years old
  2. Diagnosis of CML-CP
  3. Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  5. Patient has adequate organ function

You CAN'T join if...

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

  1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment
  2. Active infection that requires systemic drug therapy
  3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
  4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
  5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
  6. Pregnant or nursing (lactating) women

Locations

  • Ascentage Investigative Site #1059 accepting new patients
    Los Angeles California 90024 United States
  • Ascentage Investigative Site #1100 accepting new patients
    Long Beach California 90813 United States
  • Ascentage Investigative Site #1062 accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ascentage Pharma Group Inc.
Links
Sign up for this study
ID
NCT06423911
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 333 study participants
Last Updated