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

Résumé

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.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   24-Week MMR Rate (Part A)

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

   Délai 24 weeks

2. Critère de jugement principal

   24-Week MMR Rate (Part B)

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

   Délai 24 weeks

3. Critère de jugement secondaire

   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.

   Délai 96 weeks after the last patient received the first study dose

4. Critère de jugement secondaire

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

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

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

5. Critère de jugement secondaire

   96-Week MMR Rate (Part A)

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

   Délai 96 weeks

6. Critère de jugement secondaire

   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

   Délai 96 weeks

7. Critère de jugement secondaire

   Cytogenic Response Rate (Part A)

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

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

8. Critère de jugement secondaire

   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

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

9. Critère de jugement secondaire

   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

   Délai 5 years after the last patient received the first study dose

10. Critère de jugement secondaire

    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

    Délai 5 years after the last patient received the first study dose

11. Critère de jugement secondaire

    Overall Survival (OS) (Part A)

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

    Délai 5 years after the last patient received the first study dose

12. Critère de jugement secondaire

    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

    Délai 5 years after the last patient received the first study dose

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

135 sites sont en recrutement

113 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

1. 15 septembre 2026

   Date d'achèvement reportée

   Primary completion delayed 576 days

   2025-12-01 → 2027-06-30

2. 15 septembre 2026

   Objectif de recrutement modifié

   Enrollment target revised up from 285 to 333

   285 → 333

3. 15 septembre 2026

   Site ajouté

   162 sites added (163 total)

   1 → 163