[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-or-refractory-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-or-refractory-acute-myeloid-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,81],{"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":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100648501","phase-1-s243249-monotherapy-in-patients-with-relapsed-or-refractory-acute-leukemia-with-a-kmt2a-or-nup98-translocation-or-relapsed-or-refractory-aml-with-npm1c-mutation-100648501",false,"NCT07722312","S243249 Monotherapy in Patients With Relapsed or Refractory Acute Leukemia With a KMT2A or NUP98 Translocation or Relapsed or Refractory AML With NPM1c Mutation","A Phase 1\u002F2, Dose Optimization and Dose Expansion, Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Menin Inhibitor S243249 Monotherapy in Patients With Relapsed or Refractory Acute Leukemia With a KMT2A or NUP98 Translocation or Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1c Mutation","Inclusion Criteria:\n\n* Aged ≥ 18 years old.\n* Negative serum pregnancy (β-hCG) test in women of childbearing potential at screening\n* Cytomorphology-confirmed diagnosis of R\u002FR acute leukemia (including AML, ALL, and mixed lineage leukemia) according to the WHO criteria in 2022. R\u002FR acute leukemia must meet at least one of the following conditions:\n* Primary refractory disease, defined as non-response to 2 courses of standard induction therapy.\n* R\u002FR disease, defined as \\> 5% blasts on bone marrow aspirate (BMA) \u002F bone marrow biopsy (BMB) after completing prior therapy.\n* Relapse after allogeneic hematopoietic stem cell transplantation (HSCT), autologous HSCT, or immunotherapy such as chimeric antigen receptor T cell therapy (CAR-T) and T cell engager (TCE).\n* Participants with secondary AML or AML transformed from myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), etc., can be included in the study, if they meet the above criteria after the disease has transformed into AML.\n* Confirmation of KMT2At, NUP98t, or NPM1c mutation using next generation sequencing (NGS), fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR) based test in an accredited local or central lab within 28 days before start of treatment.\n* Peripheral blood white blood cell (WBC) count ≤ 25 mm3 (hydroxyurea, steroids, or vincristine to reduce peripheral WBC count is permitted).\n* Participants will be at least 2 weeks from prior therapy (except hydroxyurea, vincristine, or steroids and prespecified prephase therapy) and recovered from nadir to no worse than Grade 1 nonhematological toxicity from the prior treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate electrolytes, liver, kidney, and cardiac function\n* Sexually active male or female participants of childbearing potential must agree to use 2 medically accepted forms of effective contraception, e.g., oral, parenteral, or implanted contraceptives; intrauterine devices; and barrier methods with spermicides, during the study and for 3 or 6 months after the final administration of investigational medicinal product (IMP), in males and females respectively. Egg donation is not allowed during the study or within 6 months of the last dose of S243249.\n* Male participants with women of childbearing potential (WOCBP) partners must use a condom during the study and for at least 3 months after the final administration of IMP.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) leukemia (including imaging abnormalities and cerebrospinal fluid (CSF) smear or flow cytometry indicating leukemia cells)).\n* Active disseminated intravascular coagulation (DIC).\n* Active uncontrolled infection (prophylaxis because of absolute neutrophil count \\[ANC\\] is excepted).\n* Diagnosis of acute promyelocytic leukemia (APL, M3).\n* Corrected QT interval calculated by Fridericia (QTcF) \\> 450 msec on screening ECG.\n* Participants with an increased pro-arrhythmic risk such as those with congenital long QT syndrome.\n* Uncontrolled or severe cardiovascular disease, , within 12 months.\n* Uncontrolled serious arrhythmias.\n* Clinically significant pericardial disease.\n* History of other malignancy within the past 5 years.\n* Participants who receive autologous hematopoietic stem cell transplantation (ASCT) or CAR-T therapy within 60 days of the first dose of S243249 or have not yet recovered from toxicity related to ASCT or CAR-T therapy.\n* Participants who receive allogeneic HSCT within 100 days of the first dose of S243249, still have active acute or chronic graft versus host disease (GVHD), or still require immune-modulating therapy.\n* Have an active infection of hepatitis B or hepatitis C.\n* Have advanced liver disease or cirrhosis.\n* Uncontrolled human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome related illness.\n* Pregnant and\u002For breast-feeding (lactating) women.\n* Participant has received anti-leukemia treatment, including chemotherapy, radiation therapy, targeted small molecule agents, biologic agents, immunotherapy, or any other investigational therapy (excluding hydroxyurea, or vincristine for cytoreduction) within 2 weeks prior to the first dose of S243249.\n* Previous treatment targeting menin, dose optimization phase only.\n* Any concomitant participation in another therapeutic clinical trial is prohibited. Any participation in another nontherapeutic clinical trial could be approved by the medical monitor.\n* Participants taking medications known to prolong the QT\u002FQTc interval (with the exception of necessary azole antifungals).\n* Ongoing toxicity from prior anti-leukemia therapy that has not resolved to Grade 1 7 days prior to the first dose of S243249 has to be approved by the medical monitor.\n* Uncontrolled active infection\n* Known allergy or hypersensitivity to menin inhibitors or any component of S243249.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The objective of this study is to establish the efficacy, safety, and tolerability of S243249 and to establish the recommended phase 2 dose (RP2D) of S243249 monotherapy in participants with relapsed\u002Frefractory (R\u002FR) acute leukemia with select mutations. Phase 1 dose optimization will determine the RP2D to be used in Phase 2 dose expansion. The study will include a screening period, a treatment period consisting of continuous 28-day cycles of treatment, a safety follow-up period and a long-term follow-up period. Participants may undergo blood tests, electrocardiogram (ECG), bone marrow aspirations, vital sign checks, questionnaires, and physical exams.",[27,28],"Relapsed or Refractory Acute Leukemia","Relapsed or Refractory Acute Myeloid Leukemia",[30,31,32,33,16,34,35,36],"NPM1c","KMT2At","NUP98t","AML","Acute Leukemia","Relapsed Refractory","S243249","NOT_YET_RECRUITING","2026-07-22",{"date":40,"type":41},"2026-07-23","ACTUAL",{"date":43,"type":20},"2026-09-20",{"date":45,"type":20},"2030-08-25",{"name":47,"class":48},"Servier","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100583709","a-single-arm-prospective-study-of-tbi--bumel-as-a-conditioning-regimen-for-salvage-hsct-in-patients-with-rr-aml-100583709","NCT06879847","A Single-arm, Prospective Study of TBI + BUMEL As a Conditioning Regimen for Salvage HSCT in Patients with R\u002FR AML","A Single-arm, Prospective Clinical Study on the Efficacy of Total Body Irradiation Combined with Busulfan and Melphalan As Conditioning Regimen for Patients with Relapsed\u002FRefractory Acute Myeloid Leukemia Undergoing Salvage HSCT","Inclusion Criteria:\n\n1. Age between 14 and 70 years (inclusive of the age limits);\n2. Patients diagnosed with relapsed\u002Frefractory (R\u002FR) AML, meeting the World Health Organization (WHO) 2016 AML diagnostic criteria, must meet one of the following definitions:\n\n   Relapsed AML: Leukemic cells reappear in peripheral blood or bone marrow blasts \\>5% after achieving complete remission (CR, CRi) (excluding other causes such as bone marrow regeneration following consolidation chemotherapy), or extramedullary leukemic infiltration occurs.\n\n   Refractory AML:Initial cases that do not respond to two courses of standard treatment. Relapse within 12 months after consolidation therapy. Relapse after 12 months with no response to conventional chemotherapy. Two or more relapses. Persistent extramedullary leukemia.\n3. Heart, liver, and kidney function must meet the following criteria:\n\n   Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3× the upper limit of normal (ULN); Total bilirubin ≤ 3× ULN; Serum creatinine ≤ 2× ULN or creatinine clearance ≥ 40 mL\u002Fmin; Left ventricular ejection fraction (LVEF), as measured by echocardiography or multi-gated acquisition (MUGA) scan, must be within the normal range (\\>50%).\n4. Availability of a suitable allogeneic donor;\n5. Life expectancy of ≥3 months;\n6. Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n7. The patient understands the study protocol and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n1. Patients had serious adverse reactions to investigational drugs such as allergies;\n2. Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation;\n3. Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;\n4. Patients received Class II or higher surgery within 4 weeks prior to enrollment;\n5. Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C;\n6. Patient has active central nervous system leukemia infiltration;\n7. Pregnant or lactating patients;\n8. Patient is currently participating in another clinical studies;\n9. Other conditions where the investigator deems the patient unsuitable for inclusion.","14 Years","70 Years",{"count":59,"type":20},40,[61],"NA","Acute myeloid leukemia (AML) is one of the hematologic malignancies, for which patients typically undergo chemotherapy to achieve complete remission. However, approximately 30% of patients fail to respond to initial treatment, and many experience relapse after achieving remission. For patients with relapsed or refractory AML, allogeneic hematopoietic stem cell transplantation (HSCT) offers a potentially curative option. Sibling-matched HSCT has demonstrated a disease-free survival rate of 20-30%, while unrelated donor transplants yield an overall survival rate of approximately 22%. Haploidentical transplantation is a viable alternative for patients lacking a sibling donor. A 2019 study involving 1,693 patients with relapsed\u002Frefractory (R\u002FR) AML revealed that haploidentical transplants yielded outcomes comparable to other transplant modalities, including HLA-matched and 9\u002F10 matched unrelated donor transplants, thus supporting haploidentical transplantation as a viable therapeutic option.\n\nThe conditioning regimen is a critical component of the transplantation. In China, the modified BU\u002FCY conditioning regimen, which combines busulfan (BU) and cyclophosphamide (CTX), is widely utilized for tumor cytoreduction and immunosuppression. Some centers also employ post-transplant cyclophosphamide (PTCy) to mitigate the risk of graft-versus-host disease (GVHD). Despite advances, relapse remains a significant challenge. Optimizing conditioning regimens to enhance tumor cell targeting and achieve deeper remission is crucial. Additionally, many patients are unfit due to prior chemotherapy, infections, and organ dysfunction, which may make them unable to tolerate high-intensity conditioning.\n\nRecent studies suggest that melphalan (MEL)-based conditioning regimens may offer advantages over CTX-based protocols. While total body irradiation (TBI) has been traditionally used in conditioning for HSCT, it is associated with considerable organ toxicity.\n\nA low-dose TBI regimen combined with BU+MEL represents a promising conditioning regimen for R\u002FR AML. In preliminary studies, 7 patients treated with this regimen successfully achieved hematopoietic stem cell engraftment. Building on these results, a clinical study is planned to evaluate further the safety and efficacy of the TBI+BUMEL (IBM) conditioning regimen in relapsed\u002Frefractory AML, with a focus on improving engraftment rates, reducing relapse rates, minimizing GVHD incidence, and enhancing overall survival outcomes.",[28],[65,28,66,67,68],"Salvage Allogeneic Hematopoietic Stem Cell Transplantation","Conditioning Regimen","Total Body Irradiation","Melphalan","RECRUITING","2025-03-11",{"date":72,"type":41},"2025-03-17",{"date":74,"type":41},"2024-12-01",{"date":76,"type":20},"2027-11-30",{"name":78,"class":79},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":80},"100495048","phase-3-selinexor-in-combination-with-had-or-cag-rregimens-in-relapsed-or-refractory-acute-myeloid-leukemia-100495048","NCT05726110","Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia","A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age:18-60 years old;\n2. Except for patients with AML-M3 with acute myeloid leukemia；\n3. Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or refractory)):(1) The standard regimen did not achieve complete remission after 2 courses of induction chemotherapy;(2) Relapse within 6 months after the first complete remission; (3) Patients who relapse after 6 months after the first complete remission, and those who fail to induce chemotherapy after the original program; (4) 2 or more recurrences; (5) Extramedullary leukemia persists；\n4. Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral blood; (2) \\>5% of bone marrow naive cells; (3) Extramedullary recurrence；\n5. The bone marrow image indicates active hyperplasia or hypoproliferation；\n6. Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) with a score of 0-2.\n\nExclusion Criteria:\n\n1. Accompanied by cerebral hemorrhage；\n2. Pregnancy；\n3. Have a mental illness or other condition that cannot proceed as planned；\n4. Severe arrhythmia, abnormal ECG (QT\\>500ms).\n\nEarly withdrawal from test criteria：\n\nParticipants have the right to withdraw from the study at any time from the trial. Exit Criteria:\n\n1. The subject or the subject's legally authorized representative requests to withdraw from the study;\n2. Participant loss to follow-up.\n\nDoctor\u002FInvestigator required subjects to terminate the trial early:\n\n1. Subjects who are unable to carry out follow-up treatment due to adverse events (serious irreversible organ function damage during treatment) who are judged by the investigator to be unsuitable for continuing the research;\n2. The subject does not adhere to the protocol, such as the use of chemotherapy drugs, etc., which affects the effectiveness and safety judgment.\n\nFor participants who withdrew early from the study (except subjects who were lost to follow-up), the reason for their early withdrawal should be recorded, and the time of the last study's medication\u002Ftreatment should be recorded, and the examination items at the time of early withdrawal from the study should be completed at the last visit, if possible.","60 Years",{"count":90,"type":20},50,[92],"PHASE3","This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia",[28],"2024-10-20",{"date":97,"type":41},"2024-10-22",{"date":99,"type":41},"2023-01-29",{"date":101,"type":20},"2024-12-31",{"name":103,"class":79},"Shanxi Bethune Hospital"]