[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615789":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":69,"collaborators":22,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":22,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":22,"enrollmentInfo":80,"targetDuration":22,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":48,"whyStopped":22,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","This cohort includes patients with relapsed and refractory leukemia. Patients firstly receive chemotherapy per center standard, followed by HLA-mismatched GPBMC infusion. Secondly, patients receive HLA-matched sibling\u002Fhaploidentical\u002Funrelated HSCT.",[13,14,15],"Procedure: Chemotherapy","Biological: HLA-mismatched GPBMC infusion","Procedure: Allogeneic Stem Cell Transplantation",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Chemotherapy","Available chemotherapy regimens include but not limited to FLAG (fludarabine, cytarabine, G-CSF), DAV (daunorubicin, cytarabine, venetoclax), IAV (idarubicin, cytarabine, venetoclax), VDCP (vincristine, daunorubicin, cyclophosphamide, prednisone), hyper-CVAD A (cyclophosphamide, vincristine, doxorubicin, dexamethasone), FC (fludarabine and cyclophosphamide), et al.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"BIOLOGICAL","HLA-mismatched GPBMC infusion","HLA-mismatched GPBMCs are infused following chemotherapy.",[9],{"type":18,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Allogeneic Stem Cell Transplantation","Patients receive conditioning including but not limited to fludarabine, cyclophosphamide, antithymocyte globulin (ATG), and total body irradiation (TBI). HLA-matched sibling\u002Fhaploidentical\u002Funrelated GPBMCs are infused at day 0. Post-transplant cyclophosphamide, tacrolimus\u002Fcyclosporin, and mycophenolate mofetil are administered as graft-versus-host disease prophylaxis.",[9],[33],{"name":34,"affiliation":35,"role":36},"Bo Cai, MD","Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":22,"email":41},"CONTACT","+861066947168","caibo2008@163.com",{"name":43,"role":39,"phone":44,"phoneExt":22,"email":45},"Yangyang Lei, MD","+861066947180","942056176@qq.com",[47],{"facility":35,"status":48,"city":49,"state":22,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Beijing","100071","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60,61,62,63,65,67],{"name":34,"role":39,"phone":40,"phoneExt":22,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":22,"email":45},{"name":34,"role":36,"phone":22,"phoneExt":22,"email":22},{"name":43,"role":64,"phone":22,"phoneExt":22,"email":22},"SUB_INVESTIGATOR",{"name":66,"role":64,"phone":22,"phoneExt":22,"email":22},"Changlin Yu, MD",{"name":68,"role":64,"phone":22,"phoneExt":22,"email":22},"Xiao Lou, MD",{"type":70,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100615789","phase-1-phase-1-study-of-chemotherapy-plus-hla-mismatched-gpbmc-infusion-bridging-to-allo-hsct-for-rr-leukemia-100615789",false,"NCT07297173","Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R\u002FR Leukemia","Phase 1 Study of Chemotherapy Combining With HLA-mismatched G-CSF Mobilized Peripheral Blood Mononuclear Cell Infusion as a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed and Refractory Leukemia","Inclusion Criteria:\n\n* Age \\>=15 years, male or female, non-limited by race or ethnicity.\n* Confirmed diagnosis of R\u002FR leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics.\n* Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\\\u003C= 3 × upper limit of normal(ULN), and total bilirubin \\\u003C= 1.5 × ULN.\n* Adequate renal function including serum creatinine \\\u003C= 2 × ULN or CrCl\\>= 40mL\u002Fmin.\n* LVEF measured by echocardiogram is within the normal range (LVEF \\> 50%).\n* The subject must have one HLA mismatched donor who is \\>= 18 years old to provide GPBMCs for the first-step infusion. If this donor is not qualified as an allo-HSCT donor, the subject must also have another donor who is \\>= 18 years old and qualified as allo-HSCT donor (i.e., matched sibling, 9-10\u002F10 loci matched unrelated, or haploidentical). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. Each subject (or his\u002Fher legal representatives) must sign the Informed Consent Form (ICF), indicating that he\u002Fshe understands the purpose and procedures of research, and is willing to participate in research.\n* Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Uncontrolled infection or hemorrhage.\n* Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.\n* Uncontrolled autoimmune disease or requiring immunosuppression treatment.\n* History of severe blood infusion reaction.\n* Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.\n* Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.\n* Major surgery within 4 weeks prior to enrollment.\n* Life-threatening illness other than leukemia or uncontrolled intercurrent illness.","ALL","15 Years",{"count":81,"type":82},5,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R\u002FR) leukemia.",[88,89],"Relapsed Leukemia","Refractory Leukemia",[91,92,93,94],"HLA-mismatched GPBMC","allo-HSCT","relapsed leukemia","refractory leukemia","2025-12-09",{"date":97,"type":98},"2025-12-22","ACTUAL",{"date":100,"type":98},"2025-12-01",{"date":102,"type":82},"2030-12-01",{"name":5,"class":6},1]