Clinical Trial

Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia

Recruiting Phase 2
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Summary
This is a phase 2, open label, single arm trial. This study aims to assess the efficacy and safety of menin inhibitor BN104 as maintenance therapy in patients with acute leukemia harboring specific genetic alterations who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible patients will be screened at 30-180 days post allo-HSCT. Participants will take BN104 100-200mg orally, twice a day, 28 days a cycle for 24-36 cycles. The primary endpoint is 2-year relapse-free survival rate since enrollment. The secondary endpoints included overall survival, event-free survival, cumulative incidence of relapse, non relpase related mortality and safety.
Trial Details
NCT Number NCT07101497
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Menin Inhibitors, Post Hematopoietic Stem Cell Transplantation, Maintenance Therapy, Acute Leukemia, KMT2A Rearrangement, NPM1 Mutation, NUP98 Gene Rearrangement
Enrollment 60 participants
Start Date 2025-08-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-03