NCT06423911 Study of Olverembatinib (HQP1351) in Patients With CML-CP
| NCT ID | NCT06423911 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ascentage Pharma Group Inc. |
| Condition | Chronic Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 333 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 333 participants in total. It began in 2024-02-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 5. Patient has adequate organ function Exclusion Criteria Patients eligible for this study must not meet any of the following criteria: 1. For Part A only: T315I or V299L 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
Contact & Investigator
Elias Jabbour, M.D.
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06423911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06423911 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 333 participants.
Is NCT06423911 currently recruiting?
Yes, NCT06423911 is actively recruiting participants. Contact the research team at clinical-trials@ascentage.com for enrollment information.
Where is the NCT06423911 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Goodyear, United States, Duarte, United States and 11 additional locations.
Who is sponsoring the NCT06423911 clinical trial?
NCT06423911 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Elias Jabbour, M.D. at M.D. Anderson Cancer Center. The trial plans to enroll 333 participants.
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