Actively Recruiting
A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 (AML, ALL, or MPAL) based on WHO 2022 criteria
- Have one of the following: NPM1 mutation without FLT3 mutation, KMT2A rearrangement or KMT2A-PTD, NUP98 rearrangement, or other menin-KMT2A dependent acute leukemia subtype approved by the research team
- Underwent allogeneic hematopoietic stem cell transplantation with at least 30 days since graft infusion
- Received menin inhibitor maintenance therapy after allo-HSCT with at least 2 complete 7-day cycles or 14 days total treatment
- In complete remission (CR, CRh, or CRi) when starting maintenance therapy
- No evidence of leukemia relapse during maintenance (bone marrow blasts under 5% without leukemia features and no extramedullary leukemia)
- Menin inhibitors used include Revumenib, BN104, Ziftomenib, HMPL-506, or others targeting menin-KMT2A interaction
- Able to understand and sign informed consent
- Have complete clinical data
You will not qualify if you...
- Morphologic relapse at start of maintenance therapy or within 28 days before (bone marrow blasts 5% or more)
- Leukemic cells present in peripheral blood at treatment start
- Uncontrolled active infection
- Severe organ dysfunction: liver enzymes ALT or AST 5 times above normal, total bilirubin 3 times above normal, severe kidney impairment (eGFR below 30 ml/min/1.73 m2), or cardiac dysfunction NYHA Class III-IV
- Acute graft-versus-host disease grade 2 or higher or chronic GVHD grade 3 or higher requiring high-dose steroids and multiple immunosuppressive drugs
- History of other cancers needing ongoing treatment (except cured or in full remission without systemic therapy)
- Gastrointestinal disorders affecting oral medication intake or absorption
- Deemed unsuitable for study by investigator
- Severely missing clinical data preventing evaluation
- Receiving other maintenance therapies like hypomethylating agents, donor lymphocyte infusion, or other targeted drugs
AI-Screening
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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.
CONTACT
H
Hai-ping Dai, M.D.
CONTACT
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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