Myeloproliferative Neoplasms Clinical Trial

A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML

Summary

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

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Full Description

This is a global, multi-center, open-label randomized and registrational phase 3 study of olverembatinib: Part A is a 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 tyrosine kinase inhibitors (TKIs). Part B is to evaluate the efficacy and safety of olverembatinib in the CML- CP patients with T315I mutation.

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Eligibility Criteria

Inclusion Criteria:

Patients eligible for inclusion in this study must meet all of the following criteria.

Age ≥ 18 years old.
Diagnosis of CML-CP
Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Written informed consent obtained prior to any screening procedures.
Patients with adequate organ functions

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria.

For Part A only: T315I mutation at any time prior to starting study treatment.
Active infection that requires systemic drug therapy
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
Pregnant or nursing (lactating) women.

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

285

Study ID:

NCT06423911

Recruitment Status:

Not yet recruiting

Sponsor:

Ascentage Pharma Group Inc.

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There is 1 Location for this study

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MD Anderson Cancer Center
Houston Texas, 77030, United States

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Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

285

Study ID:

NCT06423911

Recruitment Status:

Not yet recruiting

Sponsor:


Ascentage Pharma Group Inc.

How clear is this clinincal trial information?

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