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

NCT07559695 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Menin Inhibitors
  • Acute Leukemia
  • Post Hematopoietic Stem Cell Transplantation
  • Maintenance Therapy
  • KMT2A Rearrangement
  • NPM1 Mutation
  • NUP98 Gene Rearrangement

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Su-ning Chen, M.D. · The First Affiliated Hospital of Soochow University

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07559695 on ClinicalTrials.gov