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

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

About this trial

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.

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 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • olverembatinib

    Drug

    olverembatinib QOD

  • Bosutinib

    Drug

    Bosutnib QD

Treatment groups

333 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

24-Week MMR Rate (Part A)

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

Time frame
24 weeks
2

24-Week MMR Rate (Part B)

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

Time frame
24 weeks

Secondary outcomes

1

96-Week MMR Rate (Part A)

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

Time frame
96 weeks
2

96-Week MMR Rate (Part B)

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

Time frame
96 weeks
3

Cytogenic Response Rate (Part A)

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

Time frame
Through 96 weeks (i.e., at 24, 48, and 96 weeks)
4

Cytogenic Response Rate (Part B)

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

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

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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