Menin inhibitor maintenance after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, real-world study of menin inhibitor maintenance given as part of routine care after allo-HSCT. Eligible patients receive a menin inhibitor chosen by their treating physician (examples include revumenib, ziftomenib, BN104, HMPL-506, or similar agents), with dosing, start time, and duration determined clinically. The study imposes no extra interventions and collects efficacy and safety data at each treatment cycle and during post-treatment survival follow-up. The protocol is conducted at The First Affiliated Hospital of Soochow University and follows patients from initiation of maintenance through survival follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 15 years.
2. Patients diagnosed with acute leukemia (including AML, ALL, and MPAL) according to the World Health Organization (WHO 2022) criteria.
3. Must meet one of the following characteristics: a. Harboring an NPM1 gene mutation (without concurrent FLT3-ITD or FLT3-TKD mutation); b. Harboring a KMT2A gene rearrangement or KMT2A-PTD; c. Harboring a NUP98 gene rearrangement; d. Other acute leukemia subtypes dependent on the menin-KMT2A interaction, if evidenced, may be enrolled upon discussion with and approval from the principal research team.
4. Has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with ≥ 30 days elapsed since the date of graft infusion.
5. Received menin inhibitor maintenance therapy after allo-HSCT and meets the following conditions: a. Received at least ≥ 2 complete cycles (7 days per cycle) of menin inhibitor therapy, or cumulative medication duration ≥ 14 days; b. Patient was in a state of CR/CRh/CRi at the initiation of maintenance therapy.
6. No evidence of leukemia relapse during menin inhibitor maintenance therapy, defined as: a. Bone marrow blasts \< 5%, and blasts do not exhibit morphological features of acute leukemia (e.g.Auer rods); b. No evidence of extramedullary leukemia (e.g. CNS leukemia or myeloid sarcoma).
7. The menin inhibitors used include but are not limited to: Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors.
8. Capable of understanding and voluntarily signing the informed consent form.
9. Complete clinical data.

Exclusion Criteria:

1. Presence of any of the following at the initiation of menin inhibitor maintenance therapy (including within 28 days prior to starting treatment): a. Morphologic relapse in bone marrow (bone marrow blasts ≥ 5%); b. Presence of leukemic cells in peripheral blood.
2. Active infection that is deemed uncontrolled by the investigator.
3. Severe organ dysfunction, including: a. Hepatic impairment: ALT or AST ≥ 5 × ULN (Upper Limit of Normal), or total bilirubin ≥ 3 × ULN; b. Severe renal impairment: eGFR \< 30 ml/min/1.73 m²; c. Cardiac dysfunction: NYHA (New York Heart Association) Class III-IV.
4. Concurrent acute graft-versus-host disease (aGVHD) ≥ Grade 2 or chronic graft-versus-host disease (cGVHD) ≥ Grade 3, requiring corticosteroids ≥ 1 mg/kg and ≥ 3 types of immunosuppressive therapy (including CNI, ruxolitinib, belumosudil, etc.).
5. History of other malignancies requiring ongoing treatment (except for malignancies that have undergone curative treatment or are assessed to be in complete remission and require no systemic maintenance therapy or radiotherapy).
6. Any gastrointestinal disorder that may affect the intake or absorption of oral medications (e.g.dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal GVHD, etc).
7. Patients deemed unsuitable for inclusion in this study by the investigator.
8. Severely missing clinical data, precluding efficacy or safety assessment.
9. Receipt of other maintenance therapies, including but not limited to hypomethylating agents, donor lymphocyte infusion (DLI), or other specific small-molecule targeted drugs.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Su-ning Chen, M.D. — The First Affiliated Hospital of Soochow University
• Study coordinator: Su-ning Chen, M.D.
• Email: chensuning@sina.com
• Phone: (0086)13814881746

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BN104 maintenance after allogeneic stem cell transplant for acute leukemia

  This trial tests whether taking the oral menin inhibitor BN104 can reduce relapse in people with acute leukemia who have specific genetic changes and are 1–6 months after an allogeneic stem cell transplant.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07101497

• Ziftomenib treatment after blood cancer transplant

  This study is testing if ziftomenib can help people with acute myeloid leukemia feel better and stay healthy after a blood cancer transplant.

  Recruiting at 2 sites Phase 1 Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT06440135

• Examining the safety of ziftomenib combinations for patients with relapsed acute myeloid leukemia

  This study is testing if combining ziftomenib with standard treatments can safely help people with relapsed acute myeloid leukemia feel better and improve their chances of recovery.

  Recruiting at 43 sites Phase 1 Kura Oncology, Inc. · Gilbert, Arizona and 44 other locations · NCT06001788

• Menin inhibitors in pediatric relapsed or refractory acute leukemia

  This study looks at kids with relapsed or treatment-resistant acute leukemia who have specific genetic changes and are treated with menin inhibitors to see how they fare.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07898436

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• Strength Training for Kids with Acute Lymphoblastic Leukemia and Lymphoblastic L lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.