[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kmt2a-rearrangement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kmt2a-rearrangement":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"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":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100549905","phase-1-ziftomenib-maintenance-post-allo-hct-100549905","NCT06440135","Ziftomenib Maintenance Post Allo-HCT","An Open Label Phase I Study of Ziftomenib as Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* 18 years or older.\n* Pathologically confirmed diagnosis of acute myeloid leukemia (AML).\n* Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.\n\n  * Complete remission (CR):\n\n    * no circulating blasts in peripheral blood and \\\u003C5% blasts in bone marrow\n    * no extramedullary disease\n    * platelet count ≥100 x 10(9)\u002FL and\u002For absolute neutrophil count ≥1000\u002FµL\n  * Complete remission with incomplete count recovery (CRi):\n\n    * no circulating blasts in peripheral blood and \\\u003C5% blasts in bone marrow\n    * no extramedullary disease\n    * platelet count \\\u003C100 x 10(9)\u002FL and\u002For absolute neutrophil count \\\u003C1000\u002FµL\n* Presence of at least one of the following molecular mutations:\n\n  * KMT2A rearrangement\n\n    * Eligibility and enrollment will be based on local mutational testing.\n    * The presence of a KMT2A rearrangement (excluding partial tandem duplication \\[PTD\\]) at the time of initial diagnosis or any other time thereafter is sufficient.\n    * Participants may receive additional treatment for AML between consent and transplant.\n  * NPM1 mutation\n\n    * Eligibility and enrollment will be based on local mutational testing.\n    * For participants being transplanted in CR1, the presence of a NPM1 mutation at screening is necessary for the purposes of eligibility.\n    * For participants being transplanted in greater than or equal to CR2, the presence of a NPM1 mutation at the time of consent is not necessary for eligibility and its presence at the time of initial diagnosis or any other time thereafter is sufficient.\n    * Participants may receive additional treatment for AML between consent and transplant.\n* Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible.\n* Will undergo first allogeneic HCT for their malignancy.\n* Transplantation will be performed with the use of conventional myeloablative (MAC) or reduced intensity conditioning (RIC).\n* HCT Donor will be one of the following:\n\n  * 5\u002F6 or 6\u002F6 (HLA-A, B, DR) matched related donor\n  * 7\u002F8 or 8\u002F8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level.\n  * Haploidentical related donor, defined as ≥ 3\u002F6 (HLA-A, B, DR) matched\n  * ≥ 4\u002F6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4\u002F6 matched with the recipient.\n* Any non-investigational GVHD prophylaxis regimen is allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Participants must have normal organ and function as defined below:\n\n  * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \\\u003C 3x institutional upper limit of normal (ULN)\n  * Total bilirubin \\\u003C 1.5 x institutional ULN (with the exception of subjects with a history of Gilbert's syndrome, for which the total bilirubin must be \\\u003C 5 x ULN)\n  * Calculated creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n* LVEF must be ≥50%, as measured by MUGA scan or echocardiogram.\n* Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing.\n* The effects of ziftomenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of other malignancy(ies) unless\n\n  * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or\n  * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up\n  * the only prior malignancy was cervical cancer in situ and\u002For basal cell or squamous cell carcinoma of the skin\n* Known diagnosis of active hepatitis B or hepatitis C\n* Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \\\u003C 50%, as measured by multigated acquisition (MUGA) scan or echocardiogram)\n* Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome\n* Systemic uncontrolled infection\n* Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 180 mmHg or diastolic BP \\> 100 mmHg)\n* QTc interval (i.e., Friderica's correction \\[QTcF\\]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.\n* Persons who are pregnant or lactating.","18 Years",{"count":53,"type":20},22,"INTERVENTIONAL",[56],"PHASE1","The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT.\n\nThe name of the study drug involved in this study is:\n\n• Ziftomenib",[59,60,29,28],"Acute Myeloid Leukemia","Acute Myeloid Leukemia in Remission",[59,62,63,29,28],"Allogeneic hematopoietic cell transplantation (HCT)","Allo-HCT","2026-03-17",{"date":66,"type":35},"2026-03-19",{"date":68,"type":35},"2024-06-11",{"date":70,"type":20},"2027-09-01",{"name":72,"class":42},"Massachusetts General Hospital",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":54,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"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":83,"type":20},60,[85],"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":90,"type":35},"2025-08-03",{"date":92,"type":20},"2025-08-01",{"date":94,"type":20},"2029-12-30",{"name":41,"class":42}]