RecruitingPhase 3NCT06423911

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

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia


Sponsor

Ascentage Pharma Group Inc.

Enrollment

285 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called olverembatinib (HQP1351) in patients with chronic-phase chronic myeloid leukemia (CML), a blood cancer, who have not responded to or cannot tolerate other targeted treatments. It includes two groups: patients who failed two or more prior treatments, and those with a specific resistant mutation called T315I. **You may be eligible if...** - You are 18 or older - You have been diagnosed with chronic myeloid leukemia in the chronic phase - Part A: You have tried and failed at least two approved targeted treatments (TKIs) - Part B: You have a T315I mutation in your cancer (a specific genetic change that makes many drugs less effective) - Your overall health and organ function are adequate **You may NOT be eligible if...** - Part A only: You have ever had a T315I mutation - You have an active serious infection - You are pregnant or breastfeeding - You have a gut condition that would affect how you absorb the drug - You are allergic to olverembatinib or a related drug (bosutinib) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGolverembatinib

olverembatinib QOD

DRUGBosutinib

Bosutnib QD


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06423911


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