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

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.

Eligibility

Study design

Outcome measures

1. Primary outcome

   24-Week MMR Rate (Part A)

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

   Time frame 24 weeks

2. Primary outcome

   24-Week MMR Rate (Part B)

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

   Time frame 24 weeks

3. Secondary outcome

   Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)

   According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.

   Time frame 96 weeks after the last patient received the first study dose

4. Secondary outcome

   Characterization of population pharmacokinetics of olverembatinib (Parts A and B)

   Blood samples will be collected to measure the plasma concentration of olverembatinib

   Time frame At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)

5. Secondary outcome

   96-Week MMR Rate (Part A)

   To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib

   Time frame 96 weeks

6. Secondary outcome

   96-Week MMR Rate (Part B)

   To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation

   Time frame 96 weeks

7. Secondary outcome

   Cytogenic Response Rate (Part A)

   To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.

   Time frame Through 96 weeks (i.e., at 24, 48, and 96 weeks)

8. Secondary outcome

   Cytogenic Response Rate (Part B)

   To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation

   Time frame Through 96 weeks (i.e., at 24, 48, and 96 weeks)

9. Secondary outcome

   Progression Free Survival (PFS) (Part A)

   To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib

   Time frame 5 years after the last patient received the first study dose

10. Secondary outcome

    Progression Free Survival (PFS) (Part B)

    To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation

    Time frame 5 years after the last patient received the first study dose

11. Secondary outcome

    Overall Survival (OS) (Part A)

    To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib

    Time frame 5 years after the last patient received the first study dose

12. Secondary outcome

    Overall Survival (OS) (Part B)

    To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation

    Time frame 5 years after the last patient received the first study dose

Dates

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

135 sites are recruiting

113 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

1. September 15, 2026

   Completion date moved later

   Primary completion delayed 576 days

   2025-12-01 → 2027-06-30

2. September 15, 2026

   Enrolment target changed

   Enrollment target revised up from 285 to 333

   285 → 333

3. September 15, 2026

   Site added

   162 sites added (163 total)

   1 → 163