Actively Recruiting
A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of menin inhibitor maintenance therapy in patients with acute leukemia who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients with high-risk subtypes, such as those with KMT2A rearrangements, face high relapse rates after transplantation. The study focuses on understanding how menin inhibitors, including drugs like Revumenib, BN104, Ziftomenib, and HMPL-506, may impact relapse-free survival and overall outcomes in a real-world setting. Eligible patients will receive menin inhibitor maintenance therapy as part of their routine clinical care, with the choice of specific drug, timing, dosage, and treatment duration decided by their doctors. The study does not impose extra interventions beyond usual clinical management. After starting maintenance therapy, patients will be monitored during each treatment cycle, and after treatment ends, survival follow-up visits will occur every three cycles to track long-term outcomes. Participants will be regularly assessed for treatment effectiveness and safety throughout the therapy and follow-up periods. Key outcomes include the two-year relapse-free survival rate, overall survival, event-free survival, relapse incidence, and treatment-related safety measures such as graft-versus-host disease. The study will continue until December 2029, providing comprehensive data on menin inhibitor use in post-transplant maintenance therapy for acute leukemia.
CONDITIONS
Brief Title
A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 15 years or older
- Diagnosed with acute leukemia (including AML, ALL, and MPAL) according to WHO 2022 criteria
- Has one of the following: NPM1 gene mutation without FLT3 mutation, KMT2A gene rearrangement or KMT2A-PTD, NUP98 gene rearrangement, or other menin-KMT2A interaction dependent acute leukemia subtype approved by research team
- Underwent allogeneic hematopoietic stem cell transplantation with at least 30 days since graft infusion
- Received menin inhibitor maintenance therapy after transplantation with at least 2 complete cycles or 14 days total medication
- In complete remission (CR/CRh/CRi) at the start of maintenance therapy
- No evidence of leukemia relapse during maintenance therapy (bone marrow blasts less than 5% and no extramedullary leukemia)
- Using menin inhibitors such as Revumenib, BN104, Ziftomenib, HMPL-506, or similar
- Able to understand and voluntarily sign informed consent
- Has complete clinical data
You will not qualify if you...
- Morphologic relapse in bone marrow (blasts 5% or more) or leukemic cells in peripheral blood within 28 days before starting maintenance therapy
- Uncontrolled active infection
- Severe organ dysfunction including liver impairment (ALT or AST 5 times upper limit or more, total bilirubin 3 times upper limit or more), severe kidney impairment (eGFR less than 30 ml/min/1.73 m²), or severe heart failure (NYHA class III-IV)
- Concurrent acute graft-versus-host disease grade 2 or higher, or chronic graft-versus-host disease grade 3 or higher requiring high-dose corticosteroids and multiple immunosuppressive therapies
- History of other cancers needing ongoing treatment except cured or in remission malignancies without maintenance therapy
- Gastrointestinal disorders affecting oral medication absorption (such as dysphagia, gastroparesis, uncontrolled diarrhea, or intestinal GVHD)
- Considered unsuitable for the study by investigator
- Severely missing clinical data preventing assessment
- Receiving other maintenance therapies such as hypomethylating agents, donor lymphocyte infusion, or specific targeted drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on individual treatment duration
Participants who receive menin inhibitor maintenance therapy as part of their routine clinical practice are observed. Efficacy and safety are assessed at every treatment cycle.
Visits at every treatment cycle during maintenance therapy
Duration - Up to 2 years after treatment completion
After completion of menin inhibitor maintenance therapy, participants are followed up to monitor survival and safety every three treatment cycles.
Follow-up visits every three treatment cycles
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Su-ning Chen, M.D.
H
Hai-ping Dai, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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