NCT06423911PHASE3Recruiting
Study of Olverembatinib (HQP1351) in Patients With CP-CML
Ascentage Pharma Group Inc.
Start Date
2/5/2024
Completion Date
2/1/2026
Summary
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Detailed Description
The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.
Eligibility Criteria
Age Range: 18 years to 99 years
Inclusion Criteria:
Patients eligible for inclusion in this study must meet all of the following criteria.
1. Age ≥ 18 years old.
2. Diagnosis of CML-CP
3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
5. Written informed consent obtained prior to any screening procedures.
6. Patients with adequate organ functions
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria.
1. For Part A only: T315I mutation at any time prior to starting study treatment.
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
6. Pregnant or nursing (lactating) women.
Interventions
DRUG
olverembatinib
DRUG
Bosutinib
Conditions
Chronic Myeloid LeukemiaCMLCML, Chronic Phase
Locations
MD Anderson Cancer Center
Houston, Texas 77030
United States