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RECRUITING
NCT07559695

A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

The objective of this observational study is to evaluate the efficacy and safety of menin inhibitor maintenance therapy in patients with acute leukemia who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible patients will receive menin inhibitor maintenance therapy as part of their routine clinical practice. Acceptable agents include, but are not limited to, Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors. This study imposes no additional interventions on clinical management. The specific menin inhibitor, initiation timing, dose adjustments, and treatment duration are determined at the investigator's discretion based on the patient's individual condition and clinical circumstances. Patients will enter the follow-up phase upon initiation of menin inhibitor maintenance therapy. Efficacy and safety will be assessed at every cycle during the treatment period. Following the completion of treatment, survival follow-up visits will be conducted every three 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.

Official title: A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-11-01

Completion Date

2029-12-31

Last Updated

2026-04-30

Healthy Volunteers

No

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China