Study of Olverembatinib for Chronic Phase Chronic Myeloid Leukemia

This study is testing a drug called olverembatinib (HQP1351) for people with chronic phase chronic myeloid leukemia (CP-CML), a type of blood cancer. It compares olverembatinib to another drug, bosutinib, in some patients. You might be able to join if you are 18 or older and have CP-CML. If you're in Part A, you would have already tried at least two other approved treatments. If you're in Part B, you would have a specific genetic change called the T315I mutation. The main goal is to see if olverembatinib leads to a higher major molecular response (MMR) rate, which means a significant reduction in cancer cells, after 24 weeks.

Study design
This is a global, multi-center, open-label (meaning you and your doctor will know which treatment you receive), randomized (meaning you're assigned to a treatment by chance) study. It plans to enroll 285 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 24 weeks, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06423911

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

Recruiting
PHASE3Ages 18–99InterventionalTreatment
Ascentage Pharma Group Inc.
~285 participants
Updated 2025-06-03 on ClinicalTrials.gov
What's tested:olverembatinibBosutinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MMR rate Part A
Measured over 24 weeks
+1 more outcome measured
Chronic Myeloid Leukemia
CML
CML, Chronic Phase
1 sites across 1 states
Texas1

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  • MMR rate Part A24 weeks

    To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib

  • MMR rate Part B24 weeks

    To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation