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Recruiting NCT06423911

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

Phase III Interventional Chronic Myeloid Leukemia CML CML, Chronic Phase

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: olverembatinib, Bosutinib.
Who it may be relevant to
Registry conditions: Chronic Myeloid Leukemia, CML, CML, Chronic Phase. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

Overview

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.

Interventions

  • Drug olverembatinib
    olverembatinib QOD
  • Drug Bosutinib
    Bosutnib QD

Primary outcome measures

  • MMR rate Part A [Time frame: 24 weeks]
  • MMR rate Part B [Time frame: 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06423911 · HQP1351CG301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗