[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100583709","a-single-arm-prospective-study-of-tbi--bumel-as-a-conditioning-regimen-for-salvage-hsct-in-patients-with-rr-aml-100583709",false,"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.","ALL","14 Years","70 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Relapsed or Refractory Acute Myeloid Leukemia",[29,27,30,31,32],"Salvage Allogeneic Hematopoietic Stem Cell Transplantation","Conditioning Regimen","Total Body Irradiation","Melphalan","RECRUITING","2025-03-11",{"date":36,"type":37},"2025-03-17","ACTUAL",{"date":39,"type":37},"2024-12-01",{"date":41,"type":21},"2027-11-30",{"name":43,"class":44},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"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.","18 Years","60 Years",{"count":56,"type":21},50,[58],"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",[27],"2024-10-20",{"date":63,"type":37},"2024-10-22",{"date":65,"type":37},"2023-01-29",{"date":67,"type":21},"2024-12-31",{"name":69,"class":44},"Shanxi Bethune Hospital"]