Actively Recruiting
Study of Olverembatinib (HQP1351) in Patients With CP-CML
Led by Ascentage Pharma Group Inc. · Updated on 2025-06-03
285
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
CONDITIONS
Official Title
Study of Olverembatinib (HQP1351) in Patients With CP-CML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years old
- Diagnosis of 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 2 2
- Written informed consent obtained prior to screening
- Adequate organ functions
You will not qualify if you...
- For Part A only: Presence of T315I mutation prior to starting study treatment
- Active infection requiring systemic drug therapy
- Gastrointestinal (GI) disease or impairment that may affect drug absorption
- Previous treatment with or hypersensitivity to olverembatinib or its excipients
- Previous treatment with or hypersensitivity to bosutinib or its excipients
- Pregnant or nursing (lactating) women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kate Shantz
CONTACT
H
Huanshan Guo
CONTACT
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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