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NCT Number: NCT06423911

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

Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B).

Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases CML CML, Chronic Phase Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ascentage Investigative Site #2107, Campbelltown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
  • Patient has adequate organ function

Exclusion criteria

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

  • For Part A only: T315I or V299L 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

Treatment and study plan

Olverembatinib

Drug

olverembatinib QOD

Bosutinib

Drug

Bosutnib QD

Primary outcomes

  1. 24-Week MMR Rate (Part A)

    Time frame: 24 weeks

    To compare the major molecular response (MMR) rate at 24 weeks for olverembatinib versus bosutinib

  2. 24-Week MMR Rate (Part B)

    Time frame: 24 weeks

    To evaluate the MMR rate by 24 weeks for olverembatinib in CML-CP patients with T315I mutation

Secondary outcomes

  1. 96-Week MMR Rate (Part A)

    Time frame: 96 weeks

    To compare the major molecular response (MMR) rate at 96 weeks for olverembatinib versus bosutinib

  2. 96-Week MMR Rate (Part B)

    Time frame: 96 weeks

    To evaluate the major molecular response (MMR) rate by 96 weeks for olverembatinib in CML-CP patients with T315I mutation

  3. Cytogenic Response Rate (Part A)

    Time frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)

    To compare the complete cytogenic response rate at all scheduled data collection time points for olverembatinib vs. bosutinib.

  4. Cytogenic Response Rate (Part B)

    Time frame: Through 96 weeks (i.e., at 24, 48, and 96 weeks)

    To evaluate the complete cytogenic response rate at all scheduled data collection time points for olverembatinib in CML-CP patients with T315I mutation

  5. Progression Free Survival (PFS) (Part A)

    Time frame: 5 years after the last patient received the first study dose

    To compare duration of PFS (i.e., from the date of randomization to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib versus bosutinib

  6. Progression Free Survival (PFS) (Part B)

    Time frame: 5 years after the last patient received the first study dose

    To evaluate duration of PFS (i.e., from the date of enrollment to the earliest occurrence of documented disease progression to AP/BP or the date of death from any cause) for olverembatinib in CML-CP patients with T315I mutation

  7. Overall Survival (OS) (Part A)

    Time frame: 5 years after the last patient received the first study dose

    To compare OS (duration from date of randomization to date of death) for olverembatinib versus bosutinib

  8. Overall Survival (OS) (Part B)

    Time frame: 5 years after the last patient received the first study dose

    To evaluate OS (duration from date of randomization to date of death) for olverembatinib in CML-CP patients with T315I mutation

  9. Number of participants with treatment-emergent and treatment-related adverse events as assessed by CTCAE v5.0 (Parts A and B)

    Time frame: 96 weeks after the last patient received the first study dose

    According to CTCAE v5.0, the number and frequency of adverse events for test drug will be assessed.

  10. Characterization of population pharmacokinetics of olverembatinib (Parts A and B)

    Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 28 days)

    Blood samples will be collected to measure the plasma concentration of olverembatinib

Study contacts

Contact information is provided by the study sponsor or research team.

Ascentage Clinical Operations

CONTACT

[email protected]

301-291-5658

Sponsors and collaborators

Lead sponsor

Ascentage Pharma Group Inc.

Industry

Registry information

Official study title

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Acronym: POLARIS-2

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 21, 2024
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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