[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640823":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":52,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":30,"enrollmentInfo":64,"targetDuration":30,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm: Thiotepa + Busulfan + Fludarabine ± ATG","EXPERIMENTAL","Patients with intermediate-2 or high-risk chronic myelomonocytic leukemia (CMML) per CPSS\u002FCPSS-mol criteria, who are scheduled to receive allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a thiotepa-containing conditioning regimen.",[13],"Drug: TBF regimen",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TBF regimen","Intravenous thiotepa 5 mg\u002Fkg\u002Fd on days -11,-10; busulfan 3.2 mg\u002Fkg\u002Fd on days -8,-7,-6; fludarabine 30 mg\u002Fm²\u002Fd on days -6 to -2; ATG per donor type (haplo\u002Funrelated: 2.5 mg\u002Fkg\u002Fd days -5 to -2; MSD: 1.125 mg\u002Fkg\u002Fd days -5 to -2). Allogeneic stem cells infused on day 0. GVHD prophylaxis: CsA, MMF, MTX per protocol.",[9],[21],"TBF (Thiotepa, Busulfan, Fludarabine) ± ATG",[23],{"name":24,"affiliation":5,"role":25},"Yuqian Sun, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+86 13717833825",null,"sunyuqian83@hotmail.com",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Xueyi Luo, MD","+86 13811936698","lll_xxx_yyy@126.com",[37],{"facility":5,"status":38,"city":39,"state":30,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Beijing","100044","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":24,"role":28,"phone":51,"phoneExt":30,"email":31},"+86 010-88326666",{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Sun Yuqian","Principal Investigator","100640823","thiotepa-containing-conditioning-regimen-for-allogeneic-hsct-in-chronic-myelomonocytic-leukemia-100640823",false,"NCT07588594","Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia","Prospective Single-Arm Clinical Study of Thiotepa-Containing Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years, any sex\u002Fgender.\n* Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to the 2022 WHO classification.\n* Intermediate-2 or high-risk CMML based on CPSS or CPSS-mol score, and planned to receive allo-HSCT.\n* Has a suitable hematopoietic stem cell donor:\n* For haploidentical donor: at least 5\u002F10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB1.\n* For unrelated donor: at least 9\u002F10 HLA match at the same five loci.\n* For matched sibling donor: 10\u002F10 HLA match at the same five loci.\n* Hematopoietic cell transplantation comorbidity index (HCT-CI) ≤ 2, with generally good health and no significant organ abnormalities or major comorbidities.\n* Adequate organ function as defined below:\n* Left ventricular ejection fraction (LVEF) ≥ 50%, and no uncontrolled tachycardia or bradycardia-tachycardia syndrome.\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2 × ULN; AST ≤ 2 × ULN.\n* Serum creatinine ≤ 1.5 × ULN.\n* Baseline oxygen saturation \\> 92%.\n* Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40%, FEV1 ≥ 50%.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Agrees not to participate in any other interventional study during the treatment period.\n* Willing and able to provide written informed consent, understand the nature, purpose, and procedures of the study, and voluntarily comply with study requirements.\n\nExclusion Criteria:\n\n* Previous allogeneic HSCT for CMML that later relapsed.\n* Unwilling or unable to receive the study treatment regimen.\n* Active hepatitis B or C, or chronic active hepatitis; known human immunodeficiency virus (HIV) infection.\n* Active uncontrolled infection, including: hemodynamic instability related to infection, new or worsening signs\u002Fsymptoms of infection, new infection lesions on imaging, or persistent fever without explanation despite no symptoms\u002Fsigns.\n* History of stroke or intracranial hemorrhage within 6 months before enrollment.\n* Known pregnancy (positive urine pregnancy test), or currently breastfeeding.\n* Diagnosis of another malignancy within the past 2 years, except for localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, breast cancer, or localized prostate cancer (Gleason score ≤ 6) that has been treated with curative intent.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.","ALL","18 Years",{"count":65,"type":66},31,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a prospective, single-arm clinical study. It aims to evaluate the effectiveness and safety of a conditioning regimen containing thiotepa (in combination with busulfan and fludarabine, with or without ATG) of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with chronic myelomonocytic leukemia (CMML) who have an intermediate-2 or high-risk prognosis.\n\nThe main goal is to evaluate 1 year RFS and OS. Other goals include assessing engraftment, overall survival, transplant-related complications, and side effects. A total of 31 participants will be enrolled.",[72],"Chronic Myelomonocytic Leukemia (CMML)",[72,74,75],"Hematopoietic Stem Cell Transplantation (HSCT)","Thiotepa","2026-05-21",{"date":78,"type":79},"2026-05-26","ACTUAL",{"date":81,"type":79},"2026-02-13",{"date":83,"type":66},"2028-05",{"name":5,"class":6},1]