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

Part of paid clinical trials in Houston, Texas.

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT06423911
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • olverembatinib — DRUG
    olverembatinib QOD
  • Bosutinib — DRUG
    Bosutnib QD

Study Details

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

Key Dates

Start date
Feb 5, 2024
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
285 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: 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
  • Other: Part B, SAT, olverembatinib arm
    To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

Primary Outcome Measure

MMR rate Part A [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
MD Anderson Cancer Center· Houston, TX

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