[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"menin-inhibitors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:menin-inhibitors":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100635977","a-real-world-study-on-the-efficacy-and-safety-of-menin-inhibitors-as-maintenance-after-allo-hsct-100635977",false,"NCT07559695","A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT","A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Age ≥ 15 years.\n2. Patients diagnosed with acute leukemia (including AML, ALL, and MPAL) according to the World Health Organization (WHO 2022) criteria.\n3. 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.\n4. Has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with ≥ 30 days elapsed since the date of graft infusion.\n5. 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\u002FCRh\u002FCRi at the initiation of maintenance therapy.\n6. No evidence of leukemia relapse during menin inhibitor maintenance therapy, defined as: a. Bone marrow blasts \\\u003C 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).\n7. The menin inhibitors used include but are not limited to: Revumenib, BN104, Ziftomenib, HMPL-506, or other menin-KMT2A interaction inhibitors.\n8. Capable of understanding and voluntarily signing the informed consent form.\n9. Complete clinical data.\n\nExclusion Criteria:\n\n1. 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.\n2. Active infection that is deemed uncontrolled by the investigator.\n3. 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 \\\u003C 30 ml\u002Fmin\u002F1.73 m²; c. Cardiac dysfunction: NYHA (New York Heart Association) Class III-IV.\n4. Concurrent acute graft-versus-host disease (aGVHD) ≥ Grade 2 or chronic graft-versus-host disease (cGVHD) ≥ Grade 3, requiring corticosteroids ≥ 1 mg\u002Fkg and ≥ 3 types of immunosuppressive therapy (including CNI, ruxolitinib, belumosudil, etc.).\n5. 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).\n6. Any gastrointestinal disorder that may affect the intake or absorption of oral medications (e.g.dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal GVHD, etc).\n7. Patients deemed unsuitable for inclusion in this study by the investigator.\n8. Severely missing clinical data, precluding efficacy or safety assessment.\n9. Receipt of other maintenance therapies, including but not limited to hypomethylating agents, donor lymphocyte infusion (DLI), or other specific small-molecule targeted drugs.","ALL","15 Years",{"count":19,"type":20},20,"ESTIMATED","OBSERVATIONAL","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).\n\nEligible 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.\n\nPatients 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.",[24,25,26,27,28,29,30],"Menin Inhibitors","Acute Leukemia","Post Hematopoietic Stem Cell Transplantation","Maintenance Therapy","KMT2A Rearrangement","NPM1 Mutation","NUP98 Gene Rearrangement","RECRUITING","2026-04-24",{"date":34,"type":35},"2026-04-30","ACTUAL",{"date":37,"type":35},"2025-11-01",{"date":39,"type":20},"2029-12-31",{"name":41,"class":42},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100600746","phase-2-phase-2-trial-of-bn104-as-post-hsct-maintenance-in-acute-leukemia-100600746","NCT07101497","Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia","Phase 2 Trial of Menin Inhibitor BN104 as Post Hematopoietic Stem Cell Transplantation Maintenance in Patients With Acute Leukemia","Inclusion Criteria:\n\n* Male or female patients.\n* Adult and adolescent patients aged ≥12 years who must weight ≥35 kg.\n* Diagnosed with acute myeloid leuekmia, acute lymphoblastic leukemia or ambiguous acute leukemia according to the World Health Organization classification of hematologic neoplams (WHO 2022).\n* Intermediate or high risk accroding to the ELN risk stratification.\n* Harboring one of the following genetic aberrations: a. somatic NPM1 mutation (without FLT3-ITD\u002FTKD co-mutations); b. KMT2A rearrangement\u002FKMT2A-PTD; c. NUP98 rearrangement; d. other genetic alterations dependent on menin-KMT2A.\n* Received allogenic hematopoietic stem cell transplantation within 30-180 days at the initiation of BN104 maintenance therapy.\n* Achieved full donor chimerism and hematologic recovery, with acute neuthrophil count (ANC) ≥1.0×10⁹\u002FL, platelets ≥75×10⁹\u002FL (no red blood cells \u002Fplatelets transfusion within 7 days, no G-CSF or GM-CSF within 72 hours).\n* Complete hematological remission (CHR) after first allo-SCT. CHR must be confirmed by bone marrow analysis within 14 days before entering the study (CHR criteria are: \"\\\u003C 5% marrow blasts, no peripheral blasts, blood platelet count \\> 75×10⁹\u002FL, WBC count \\> 3.5 G\u002FL, ANC ≥ 1.0×10⁹\u002FL).\n* No extramedullary leukemia.\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.\n* Adequate organ function\n* Provided informed consent by all patients and the guardians ( aged 12-17 years).\n* Written informed consent.\n* ECOG ≥ 2.\n\nExclusion Criteria:\n\n* Complicated with active and uncontrolled infections.\n* Activation of virus, (e.g., CMV viremia with CMV DNA copies \\> 400 copies\u002Fml, EBV viremia with EBV DNA copies \\> 400 copies\u002Fml, and proof of activation of adenovirus and Human Parvovirus B19 ).\n* Activation of hepatitis B, hepatitis C, or human immunodeficiency virus.\n* Cardiac disease as followings: a. inherited long QT syndrome. b. Congestive heart failure with NYHA ≥ grade 2.\n* ≥ grade 2 acute GVHD or ≥ grade 3 chronic GVHD which requiring systemic therapy.\n* Have received other maintenance therapies (e.g., hypomethylating agents, targetd drugs such as Bcl-2 inhibitors, FLT3 inhibitors, IDH1\u002F2 inhibitors, interferon, interleukin-2, donor lymphocyte infusion and chemotherapy).\n* History of other malignancies which needed systemic treatment (excluding those in stable remission without maintenance therapy).\n* Any gastrointestinal condition that may interfere with oral drug intake or absorption (e.g., dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal graft versus host disease.\n* Pregnancy, breastfeeding\n* Hypersensitivity to BN104.","12 Years",{"count":53,"type":20},60,"INTERVENTIONAL",[56],"PHASE2","This is a phase 2, open label, single arm trial. This study aims to assess the efficacy and safety of menin inhibitor BN104 as maintenance therapy in patients with acute leukemia harboring specific genetic alterations who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nEligible patients will be screened at 30-180 days post allo-HSCT. Participants will take BN104 100-200mg orally, twice a day, 28 days a cycle for 24-36 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.",[24,26,27,25,28,29,30],"2025-07-28",{"date":61,"type":35},"2025-08-03",{"date":63,"type":20},"2025-08-01",{"date":65,"type":20},"2029-12-30",{"name":41,"class":42}]