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
Study ID
NCT07559695
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 30, 2026
Start date
Nov 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Post-alloHSCT menin maintenance
    Patients with acute leukemia who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) and received menin inhibitor maintenance therapy after transplantation. Menin inhibitors include but are not limited to Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors.

Primary Outcome Measure

2-year rate of RFS [ Time Frame: 2 years ]

Central Contacts

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