OncoMatch/Clinical Trials/NCT06423911
Study of Olverembatinib (HQP1351) in Patients With CML-CP
Official title: A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)
Is NCT06423911 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies multiple treatments including olverembatinib and Bosutinib for chronic myeloid leukemia.
Treatment: olverembatinib · Bosutinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: ABL1 bcr-abl1 fusion
Diagnosis of CML-CP
Required: ABL1 t315i
Part B: T315I mutation at screening
Excluded: ABL1 t315i
For Part A only: T315I ... mutation at any time prior to starting study treatment
Excluded: ABL1 v299l
For Part A only: ... V299L mutation at any time prior to starting study treatment
Disease stage
Required: Stage CHRONIC PHASE
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor
Part A: Previously treated with at least two approved TKIs
Must have received: tyrosine kinase inhibitor
Part B: ...previously treated with at least one approved TKI
Cannot have received: olverembatinib (olverembatinib)
Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients
Cannot have received: bosutinib (bosutinib)
Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ascentage Investigative Site #1044 · Birmingham, Alabama
- Ascentage Investigative Site #1112 · Anchorage, Alaska
- Ascentage Investigative Site #1111 · Goodyear, Arizona
- Ascentage Investigative Site #1062 · Duarte, California
- Ascentage Investigative Site #1099 · Irvine, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06423911 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior olverembatinib, bosutinib disqualifies patients from enrollment.
Does this trial require ABL1?
Yes, ABL1 bcr-abl1 fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 t315i is a required biomarker for enrollment.
Are patients with ABL1 alterations eligible?
No. ABL1 t315i is an exclusion criterion.
Are patients with ABL1 alterations eligible?
No. ABL1 v299l is an exclusion criterion.
What disease stage is eligible?
Stage CHRONIC PHASE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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