Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2)

Ascentage Pharma Group

Status and phase: Enrolling; Phase 3

Conditions: CML; Chronic Myeloid Leukemia; CML, Chronic Phase

Treatments: Drug: Bosutinib; Drug: olverembatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06423911

HQP1351CG301

Details and patient eligibility

About

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

Full 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.

Enrollment: 285 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 2 patient groups

Part A, RCT, olverembatinib arm and bosutinib arm

Other group

Description:

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

Treatment:

Drug: olverembatinib

Drug: Bosutinib

Part B, SAT, olverembatinib arm

Other group

Description:

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

Treatment:

Drug: olverembatinib