Study of Olverembatinib (HQP1351) in Patients With CP-CML
Recruiting
Phase 3
Interventional Study
Chronic Myeloid Leukemia
CML
CML, Chronic Phase
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 285 (estimated)
- Sponsor
- Ascentage Pharma Group Inc. · Industry
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About This Trial
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Trial Locations
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Eligibility Criteria
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) p…
Contacts