Treatment of Chronic Myeloid Leukemia with Olverembatinib

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

This study is testing if a new drug called olverembatinib can help people with chronic myeloid leukemia feel better compared to an existing treatment, and it looks at two groups of patients based on a specific genetic mutation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Drugs / interventions: olverembatinib, bosutinib
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06423911 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of olverembatinib (HQP1351) in patients with chronic phase chronic myeloid leukemia (CP-CML). It is a global, multicenter, open-label, randomized Phase 3 study that compares olverembatinib to bosutinib in two parts: one for patients without the T315I mutation and another for those with the mutation. The study aims to determine if olverembatinib can achieve a higher major molecular response (MMR) rate and provide therapeutic benefits for both patient groups. Participants will be monitored for safety and efficacy throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with chronic phase chronic myeloid leukemia who have previously been treated with at least two approved tyrosine kinase inhibitors.

Not a fit: Patients who have the T315I mutation prior to starting treatment in Part A or those with active infections or gastrointestinal impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with chronic myeloid leukemia, particularly those with the T315I mutation.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific treatment is being evaluated for its unique efficacy in CP-CML patients.

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) performance status (PS) ≤ 2.
5. Written informed consent obtained prior to any screening procedures.
6. Patients with adequate organ functions

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria.

1. For Part A only: T315I mutation at any time prior to starting study treatment.
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
6. Pregnant or nursing (lactating) women.

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Kate Shantz

Conditions Chronic Myeloid Leukemia; CML; CML, Chronic Phase