Clinical Trial

Lisaftoclax Plus Azacitidine Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse

Not Yet Recruiting Phase 3
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Summary
This study evaluates the efficacy and safety of maintenance therapy with lisaftoclax plus azacitidine after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with acute myeloid leukemia (AML) at high risk of relapse. The main questions this study aims to answer are: * Does maintenance therapy with lisaftoclax plus azacitidine improve disease-free survival compared with observation alone after allo-HSCT? * Does maintenance therapy reduce relapse and improve overall survival? * What adverse events and safety outcomes are associated with this treatment strategy? Researchers will compare maintenance therapy with lisaftoclax plus azacitidine with observation or best supportive care in patients with AML at high risk of relapse following allo-HSCT. Participants will: * Be randomly assigned in a 2:1 ratio to receive either maintenance therapy with lisaftoclax plus azacitidine or observation. * Receive study treatment for up to 12 cycles or undergo observation according to the study assignment. * Undergo regular follow-up assessments, disease monitoring, and safety evaluations after transplantation.
Trial Details
NCT Number NCT07686965
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Acute Myeloid Leukemia (AML), Maintenance Treatment, Hematopoetic Stem Cell Transplantation
Enrollment 191 participants
Start Date 2026-08-10
Primary Completion 2030-08-10 (estimated)
Study Completion 2030-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-07