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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2026-02-28

Brief Summary

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A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

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Detailed Description

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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.

Conditions

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Chronic Myeloid Leukemia CML CML, Chronic Phase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part A 2:1 ratio Part B: control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

olverembatinib

Intervention Type DRUG

olverembatinib QOD

Bosutinib

Intervention Type DRUG

Bosutnib QD

Part B, SAT, olverembatinib arm

To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Group Type OTHER

olverembatinib

Intervention Type DRUG

olverembatinib QOD

Interventions

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olverembatinib

olverembatinib QOD

Intervention Type DRUG

Bosutinib

Bosutnib QD

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No