Clinical Trial

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Recruiting Phase 2
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Summary
This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-04-06; most recent amendment 2025-07-27.
Status change: Not Yet Recruiting → Recruiting 2021-11-10
Trial Details
NCT Number NCT04838041
Lead Sponsor Medical College of Wisconsin
Collaborators: H. Jean Khoury Cure CML Consortium
Conditions Chronic Phase Chronic Myelogenous Leukemia
Enrollment 51 participants
Start Date 2021-11-11
Primary Completion 2028-06 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2025-07-30