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

Conditions

• CML
• CML, Chronic Phase
• Chronic Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• olverembatinib — DRUG
  olverembatinib QOD
• Bosutinib — DRUG
  Bosutnib QD

Study Details

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.

Key Dates

First listed

May 21, 2024

Start date

Feb 5, 2024

Status verified

Sep 2026

Primary completion

Jun 30, 2027

Completion

Jul 10, 2028

Study Design

Enrollment

333 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Part A, RCT, olverembatinib arm and bosutinib arm
  Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs
• Other: Part B, SAT, olverembatinib arm
  To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Primary Outcome Measure

24-Week MMR Rate (Part A) [ Time Frame: 24 weeks ]

Central Contacts

• Ascentage Clinical Operations
  301-291-5658
  [email protected]

Locations (50)

Find similar trials in Birmingham, AL

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