Actively Recruiting
Global, Open-label, Randomized Phase 3 Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia
Led by Ascentage Pharma Group Inc. · Updated on 2025-06-03
285
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of olverembatinib (HQP1351) in patients with chronic phase chronic myeloid leukemia (CML-CP). The study is a global, multicenter, open-label, randomized Phase 3 trial sponsored by Ascentage Pharma Group Inc. It focuses on patients previously treated with at least two tyrosine kinase inhibitors (TKIs) and includes those with and without the T315I mutation. The goal is to compare olverembatinib with bosutinib in patients without the mutation and assess olverembatinib's benefits in those with the mutation. The study includes two parts: Part A is a randomized controlled trial comparing olverembatinib taken every other day to bosutinib taken daily in CML-CP patients without the T315I mutation. Part B is a single-arm trial evaluating olverembatinib in patients with the T315I mutation. Treatment schedules and doses are based on these regimens, and the study evaluates efficacy and safety over time. Participants will be monitored for molecular response rates at 24 weeks in both parts of the study. Researchers will assess safety, organ function, and performance status. Informed consent and adequate organ function are required, and participants will undergo regular clinical evaluations to measure outcomes and monitor for side effects. The study is expected to continue until February 2026, with ongoing safety and efficacy assessments throughout participation.
CONDITIONS
Brief Title
Study of Olverembatinib (HQP1351) in Patients With CP-CML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with chronic phase chronic myeloid leukemia (CML-CP)
- Part A: Previously treated with at least two approved tyrosine kinase inhibitors (TKIs)
- Part B: Presence of T315I mutation at screening
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Provided written informed consent before any screening
- Adequate organ function
You will not qualify if you...
- For Part A: Presence of T315I mutation before starting study treatment
- Active infection requiring systemic drug therapy
- Gastrointestinal problems that may affect drug absorption
- Previous treatment with or allergy to olverembatinib or its components
- Previous treatment with or allergy to bosutinib or its components
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive olverembatinib or bosutinib to treat chronic phase chronic myeloid leukemia, depending on their study arm assignment.
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kate Shantz
H
Huanshan Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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