[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651250":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":20,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":31,"maxAge":32,"enrollmentInfo":33,"targetDuration":20,"studyType":36,"phases":37,"briefSummary":40,"conditions":41,"keywords":20,"overallStatus":44,"whyStopped":20,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":20},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"salvage treatment","EXPERIMENTAL","Salvage chemotherapy with Sonrotoclax, cladribine, and standard-dose cytarabine in patients with relapsed\u002Frefractory acute myeloid leukemia.",[13],"Drug: Sonrotoclax, cladribine, and standard-dose cytarabine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sonrotoclax, cladribine, and standard-dose cytarabine","After enrollment, patients will receive salvage chemotherapy with Sonrotoclax, cladribine, and standard-dose cytarabine, and will be bridged to allogeneic hematopoietic stem cell transplantation within 1 to 4 weeks after completion of chemotherapy. Following hematopoietic reconstitution post-transplantation, Sonrotoclax may be administered as maintenance therapy at the investigator's discretion.",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100651250","phase-1-salvage-chemotherapy-with-sonrotoclax-cladribine-and-standard-dose-cytarabine-sequentially-followed-by-hsct-for-rr-aml-100651250",false,"NCT07757672","Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R\u002FR AML.","A Prospective Phase II Clinical Trial of Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1.Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics.\n* 2\\. Patients who are planned to undergo allogeneic hematopoietic stem cell transplantation, including HLA-matched or HLA-mismatched related allogeneic transplantation, as well as unrelated donor transplantation.\n* 3\\. Age between 18 and 65 years, inclusive, regardless of gender.\n* 4\\. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2.\n* 5\\. Written informed consent must be obtained prior to the initiation of any study-related procedures. For patients aged 18 years or older, the consent form may be signed by the patient or by a direct relative. Should the patient's own signature be judged to be potentially harmful to their clinical care, consent may instead be given by a legal guardian or a direct relative.\n\nExclusion Criteria:\n\n* 1\\. Uncontrolled active infection (bacterial, fungal, or viral).\n* 2\\. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV).\n* 3\\. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements.\n* 4\\. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.\n* 5\\. Prior hematopoietic stem cell transplantation.\n* 6\\. Active cardiac disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to study enrollment; History of arrhythmia requiring medication or clinically significant symptomatic arrhythmia; Uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] class 2); Ejection fraction below the lower limit of normal; Previous coronary angioplasty or stent implantation.\n* 7\\. Severe hepatic impairment, defined as liver function parameters (ALT, TBIL) \\> 3 × upper limit of normal (ULN); or severe renal impairment, defined as serum creatinine (Cr) \\> 2 × ULN, or 24-hour urine creatinine clearance \\\u003C 50 mL\u002Fmin; or any other condition that, in the investigator's opinion, renders the patient unsuitable for treatment with the study drug.\n* 8\\. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.","ALL","18 Years","65 Years",{"count":34,"type":35},50,"ESTIMATED","INTERVENTIONAL",[38,39],"PHASE1","PHASE2","The goal of this clinical trial is to treat adult patients with relapsed\u002Frefractory acute myeloid leukemia (AML) using a salvage chemotherapy regimen consisting of Sonrotoclax, cladribine, and standard-dose cytarabine, sequentially followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:\n\nDoes this treatment regimen improve the 2-year overall survival (OS) rate, relapse-free survival (RFS) rate, and cumulative incidence of relapse (CIR) in this patient population?\n\nWhat is the safety profile of this combination and sequential transplant strategy, particularly regarding treatment-related mortality (TRM) and adverse events?\n\nAs this is a single-arm phase II study, there is no comparator group.\n\nParticipants will:\n\nReceive salvage chemotherapy with cladribine (5 mg\u002Fm² on days 1-5), cytarabine (100 mg\u002Fm² twice daily on days 1-5), and Sonrotoclax (escalating doses from 40 mg to 320 mg on days 1-14).\n\nUndergo allogeneic hematopoietic stem cell transplantation as a bridge therapy within 1 to 4 weeks after completing chemotherapy.\n\nPotentially receive Sonrotoclax as maintenance therapy after hematopoietic reconstitution post-transplant, at the investigator's discretion.\n\nUndergo regular follow-up visits for clinical assessments, disease monitoring, and survival evaluation.",[42,43],"AML (Acute Myelogenous Leukemia","HSCT","NOT_YET_RECRUITING","2026-08-05",{"date":47,"type":48},"2026-08-11","ACTUAL",{"date":50,"type":35},"2026-09-01",{"date":52,"type":35},"2029-04-30",{"name":5,"class":6}]