[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534393":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":44,"studyPopulation":37,"armGroups":45,"interventions":52,"overallOfficials":60,"centralContacts":65,"locations":37,"responsibleParty":74,"collaborators":37,"id":76,"slug":37,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":37,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":37,"enrollmentInfo":84,"targetDuration":37,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":37,"overallStatus":94,"whyStopped":37,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":37},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"acute graft-versus-host disease","Acute graft-versus-host disease severity is usually graded (grades 0-IV) by the pattern of organ involvement using the classic Glucksberg-Seattle criteria (GSC). Higher grades mean a worse outcome.","100 days",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"chronic graft-versus-host disease","The National Institutes of Health scoring system (National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report) was used to define chronic GVHD. The standardization provided by the National Institutes of Health (NIH) 2005 and 2014 consensus projects has helped improve diagnostic accuracy and severity scoring (including grades mild, moderate, and severe) for clinical trials. Higher scores mean a worse outcome.","1-year",{"measure":19,"description":20,"timeFrame":17},"recurrence free survival","Recurrence Free Survival is defined as the time interval between the day of reference in the study (date of randomization, date of diagnosis, etc.) and the date of local relapse\u002Frecurrence or regional relapse\u002Frecurrence or death (all causes) whichever occurs first.",{"measure":22,"description":23,"timeFrame":17},"non-relapse mortality","Non-relapse mortality was defined as death from any cause other than malignancy relapse.",{"measure":25,"description":26,"timeFrame":17},"cumulative incidence of relapse","cumulative incidence of relapse was measured from the date of transplantation until the date of hematologic relapse.",{"measure":28,"description":29,"timeFrame":17},"overall survival","The time from transplantation to any cause death or the last follow-up was defined as overall survival.",{"measure":31,"description":32,"timeFrame":17},"GVHD-free\u002F relapse-free survival","GVHD-free\u002F relapse-free survival events were defined as grade 3-4 aGVHD or cGVHD requiring systemic immunosuppressive treatment, disease relapse, or any-cause death during the first 12 months after allogeneic HCT.",{"measure":34,"description":35,"timeFrame":36},"PD-L1 expression in acute myeloid leukemia bone marrow cells","The expression levels of PD-L1 in acute myeloid leukemia bone marrow cells will be assessed at the 28th day after each medication cycle.","Up to 1 year post-treatment",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"NA","SINGLE_GROUP","PREVENTION",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE","ATG (anti-thymocyte globulin, rabbit; 5 mg\u002Fkg, day -5 to -2) was used in matched sibling donor-HSCT. ATG (1.5 mg\u002Fkg, day -5; 2.5 mg\u002Fkg, day -4; mathematical function was then exploited to determine the total targeted ATG dose on day -3 to -2 based on concentrations of active ATG on day -5 to -4) was used in both haploidentical donor-HSCT and unrelated donor-HSCT. Reduced-dose PTCy regimen: two doses of 14.5 mg\u002Fkg Cy were given on days +3 and +4 post-HSCT.",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Combination of PTCy and ATG for GVHD prophylaxis","EXPERIMENTAL","ATG (anti-thymocyte globulin, rabbit; 5 mg\u002Fkg, day -5 to -2) was used in matched sibling donor-HSCT. ATG (1.5 mg\u002Fkg, day -5; 2.5 mg\u002Fkg, day -4; mathematical function was then exploited to determine the total targeted ATG dose on day -3 to -2 based on concentrations of active ATG on day -5 to -4) was used in both haploidentical donor-HSCT and unrelated donor-HSCT. Reduced-dose PTCy (two doses of 14.5 mg\u002Fkg Cy was given on days +3 and +4 post-HSCT) was used of GVHD prophylaxis.",[51],"Drug: Cyclophosphamid",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Cyclophosphamid","ATG (anti-thymocyte globulin, rabbit; 5 mg\u002Fkg, day -5 to -2) was used in matched sibling donor-HSCT. ATG (1.5 mg\u002Fkg, day -5; 2.5 mg\u002Fkg, day -4; mathematical function was then exploited to determine the total targeted ATG dose on day -3 to -2 based on concentrations of active ATG on day -5 to -4) was used in both haploidentical donor-HSCT and mismatched unrelated donor-HSCT. Reduced-dose PTCy (two doses of 14.5 mg\u002Fkg Cy was given on days +3 and +4 post-HSCT) was used of GVHD prophylaxis.",[47],[59],"Anti-thymocyte globulin",[61],{"name":62,"affiliation":63,"role":64},"Xiaoning Gao, Doctor","Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[66,70],{"name":62,"role":67,"phone":68,"phoneExt":37,"email":69},"CONTACT","+86-010-66947169","gaoxn@263.net",{"name":71,"role":67,"phone":72,"phoneExt":37,"email":73},"Yuxin Wang, Doctor","15147159987","wyx15147159987@163.com",{"type":75,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100534393",false,"NCT06238245","Combination of ATG-based Conditioning Regimen and PTCy for GVHD Prevention in Allo-HSCT After PD-1 Blockade","A Prospective, Single-Arm Clinical Study of Anti-thymocyte Globulin-based Conditioning Regimen Combined With Post-Transplantation Cyclophosphamide for GVHD Prevention in Allogeneic HSCT After PD-1 Blockade","Inclusion Criteria:\n\n* (1) age ≥ 18 years old, regardless of gender;\n* (2) patients with hematological malignancies (including lymphoma, leukemia, myelodysplastic syndrome, etc.) who had received at least one course of PD-1 antibody treatment;\n* (3) patients with indications for allo-HSCT, available donors (including matched sibling donors, haploidentical donors and unrelated donors), and no contraindications for transplantation;\n* (4) patients suitable for conventional Bu\u002FFlu conditioning regimen;\n* (5) no serious heart, liver, kidney, lung and other important organ diseases;\n* (6) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;\n* (7) Hematopoietic stem cell transplantation comorbidity index (HCT-CI) score was 0-3;\n* (8) expected survival time of at least 12 weeks;\n* (9) women who are not pregnant or breastfeeding;\n* (10) voluntary participation in clinical research; They or their legal guardians were fully aware of the study and signed informed consent. Willing to follow and complete all trial procedures;\n\nExclusion Criteria:\n\n* (1) pregnant or lactating women;\n* (2) other serious conditions that may limit enrollment (e.g., advanced infection, etc.);\n* (3) unable to understand and follow the study protocol or sign the informed consent form.","ALL","18 Years",{"count":85,"type":86},22,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The aim of this study is to evaluate the efficacy and safety of anti-thymocyte globulin combined with PTCy (post-HSCT cyclophosphamide, PTCy) in preventing graft-versus-host disease (GVHD) in allo-HSCT patients after anti-PD-1(anti-programmed cell death protein 1) antibody treatment. In this study, patients with hematological malignancies who needed to receive allo-HSCT after PD-1 antibody treatment were selected as the research subjects. Fludarabine and Busulfan was used as the conditioning regimen, and the dose of ATG (anti-thymocyte globulin, ATG) combined with PTCy was used as the GVHD prevention regimen. The aim of this study is to reduce the incidence of Regimen-Related Toxicity and GVHD without affecting engraftment and relapse, thereby reducing non-relapse mortality and further improving the survival of patients.",[92,93],"Graft-versus-host Disease","Hematological Malignancies","NOT_YET_RECRUITING","2024-02-19",{"date":97,"type":98},"2024-02-20","ACTUAL",{"date":100,"type":86},"2024-02-28",{"date":102,"type":86},"2026-06-30",{"name":5,"class":6}]