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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

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Conditions

Chronic Myeloid LeukemiaCMLCML, Chronic Phase

Locations

MD Anderson Cancer Center

Houston, Texas 77030

United States