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

ConditionsChronic Myeloid LeukemiaCMLCML, Chronic Phase
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAscentage Pharma Group Inc.

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • olverembatinib

    Drug

    olverembatinib QOD

  • Bosutinib

    Drug

    Bosutnib QD

Treatment groups

285 Participants
are divided into 2 treatment groups
Group A: Part A, RCT, olverembatinib arm and bosutinib armOther 2 interventions
Group B: Part B, SAT, olverembatinib armOther 1 intervention

Trial outcomes

Primary outcomes

1

MMR rate Part A

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

Time frame
24 weeks
2

MMR rate Part B

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

Time frame
24 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascentage Pharma Group Inc.

Lead sponsor

Source ClinicalTrials.gov
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