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

Resumen

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.

Elegibilidad

Diseño del estudio

Variables de resultado

1. Variable de resultado principal

   24-Week MMR Rate (Part A)

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

   Plazo 24 weeks

2. Variable de resultado principal

   24-Week MMR Rate (Part B)

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

   Plazo 24 weeks

3. Variable de resultado secundaria

   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.

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

4. Variable de resultado secundaria

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

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

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

5. Variable de resultado secundaria

   96-Week MMR Rate (Part A)

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

   Plazo 96 weeks

6. Variable de resultado secundaria

   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

   Plazo 96 weeks

7. Variable de resultado secundaria

   Cytogenic Response Rate (Part A)

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

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

8. Variable de resultado secundaria

   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

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

9. Variable de resultado secundaria

   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

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

10. Variable de resultado secundaria

    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

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

11. Variable de resultado secundaria

    Overall Survival (OS) (Part A)

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

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

12. Variable de resultado secundaria

    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

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

Fechas

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

135 centros están en reclutamiento

En el registro figuran 113 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

1. 15 de septiembre de 2026

   Fecha de finalización aplazada

   Primary completion delayed 576 days

   2025-12-01 → 2027-06-30

2. 15 de septiembre de 2026

   Objetivo de inscripción modificado

   Enrollment target revised up from 285 to 333

   285 → 333

3. 15 de septiembre de 2026

   Centro añadido

   162 sites added (163 total)

   1 → 163