[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-graft-versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-graft-versus-host-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,41,66,94,120,144,172,197,221,243,264,286,310,331,359,383,407,433,455,478,498,517,537],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634078","dental-cleaning-to-prevent-chronic-graft-versus-host-disease-100634078",false,"NCT07535008","Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed. Any conditioning regimen is allowed\n* One of the following HCT donor types:\n\n  * 9\u002F10 or 10\u002F10 human leukocyte antigen (HLA)-matched unrelated donor\n  * Cord blood\n* Willing to have an in-person 1-year long-term follow-up (LTFU) visit including an oral medicine at Fred Hutch (FH)\n* Ability to understand and sign a written informed consent document (or legal representative)\n\nExclusion Criteria:\n\n* Edentulous state\n* Bone marrow as graft source\n* Use of post-transplantation cyclophosphamide (PTCy) or ruxolitinib as GVHD prophylaxis\n* Use of anti-thymocyte globulin (ATG) in conditioning","ALL","18 Years",{"count":18,"type":19},45,"ESTIMATED","INTERVENTIONAL",[22],"NA","This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.",[25,26,27],"Chronic Graft Versus Host Disease","Acute Graft Versus Host Disease","Hematopoietic and Lymphatic System Neoplasm","RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":19},"2026-07-15",{"date":36,"type":19},"2029-04-30",{"name":38,"class":39},"Fred Hutchinson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":15,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100297187","fmt-in-gut-agvhd-treated-100297187","NCT03148743","FMT in Gut aGVHD Treated","Department of Hematology of First Affiliated Hospital of Soochow University","Inclusion Criteria:\n\n* gut GVHD\n\nExclusion Criteria:\n\n* Age\\>60; or Age\\\u003C10",true,"10 Years","60 Years",{"count":52,"type":19},50,"OBSERVATIONAL","With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.",[56],"Acute-graft-versus-host Disease","2026-05-28",{"date":59,"type":32},"2026-06-01",{"date":61,"type":32},"2017-05-16",{"date":63,"type":19},"2029-12-01",{"name":65,"class":39},"The First Affiliated Hospital of Soochow University",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":40},"100636975","phase-2-moxibustion-for-steroid-refractory-acute-graft-versus-host-disease-after-allogeneic-hematopoietic-stem-cell-transplantation-100636975","NCT07572669","Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","A Prospective, Multicenter, Open-Label, Phase II Study to Evaluate the Safety and Efficacy of Moxibustion in Patients With Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\nAge 14 to 65 years, male or female. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). Diagnosis of acute graft-versus-host disease (aGVHD) according to standard criteria, with gastrointestinal involvement (e.g., abdominal pain and diarrhea), and classified as grade II-IV.\n\nSteroid-refractory or steroid-dependent aGVHD, defined as:\n\nDisease progression within 3 days of systemic corticosteroid treatment, or No response within 7 days, or Failure to achieve complete response after 28 days of immunosuppressive therapy, or Recurrence or worsening during steroid tapering. Absolute neutrophil count ≥ 0.5 × 10⁹\u002FL for at least 3 consecutive days. Traditional Chinese medicine (TCM) syndrome differentiation consistent with spleen-kidney yang deficiency.\n\nFemale participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study.\n\nMale participants must agree to use effective contraception during the study. Ability to understand and willingness to sign a written informed consent form. Willingness and ability to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\nPrior treatment with ≥1 systemic therapy for aGVHD other than corticosteroids. Diagnosis of GVHD overlap syndrome according to NIH criteria. History of splenectomy after transplantation. Evidence of relapse of the underlying disease or receipt of anti-relapse therapy after transplantation.\n\nUnresolved toxicities or complications from prior transplantation (excluding GVHD).\n\nPrior moxibustion therapy after transplantation. Uncontrolled active infection. Known human immunodeficiency virus (HIV) infection. Active hepatitis B or C infection requiring treatment, or risk of HBV reactivation.\n\nReceipt of other investigational therapy within 21 days prior to enrollment (or within 5 half-lives, whichever is longer).\n\nRenal dysfunction: serum creatinine ≥ 2.0 mg\u002FdL or creatinine clearance \\\u003C 40 mL\u002Fmin.\n\nHepatic dysfunction unrelated to GVHD, including cholestatic disease or unresolved hepatic veno-occlusive disease.\n\nSevere cardiovascular disease, including unstable angina, myocardial infarction within 6 months, NYHA class III-IV heart failure, or circulatory failure requiring vasoactive support.\n\nSevere respiratory disease requiring mechanical ventilation or ≥50% oxygen support.\n\nUse of high-dose corticosteroids (≥1 mg\u002Fkg\u002Fday methylprednisolone or equivalent) for non-GVHD indications within 7 days prior to enrollment.\n\nPregnant or breastfeeding women. Severe skin damage or known allergy\u002Fintolerance to study-related procedures. Any other condition that, in the investigator's judgment, would interfere with study participation.","14 Years","65 Years",{"count":76,"type":19},42,[78],"PHASE2","This study is a prospective, multicenter, open-label, phase II clinical trial designed to evaluate the safety and efficacy of moxibustion in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nA total of 42 patients with SR-aGVHD, primarily involving the gastrointestinal tract and presenting with abdominal pain and diarrhea, will be enrolled. All participants will receive standard second-line therapy based on best available treatment (BAT), including ruxolitinib, basiliximab, or methotrexate, according to clinical judgment. In addition, patients will receive moxibustion at specific acupoints (Tianshu \\[ST25\\], Shenque \\[CV8\\], and Qihai \\[CV6\\]) for 30 minutes once or twice daily for 28 days.\n\nThe primary endpoint is the overall response rate (ORR) at Day 28. Secondary endpoints include durable ORR at Day 56, incidence and severity of chronic GVHD (cGVHD), non-relapse mortality (NRM), overall survival (OS), and changes in traditional Chinese medicine (TCM) syndrome scores. Safety will be assessed by monitoring adverse events throughout the study period.\n\nThis study aims to explore whether moxibustion, as an adjunctive therapy, can improve clinical outcomes and provide a safe and effective treatment strategy for patients with SR-aGVHD after allo-HSCT.",[81,82,83,84],"Steroid-Refractory Acute Graft-Versus-Host Disease","Acute Graft-Versus-Host Disease","Graft-Versus-Host Disease","Allogeneic Hematopoietic Stem Cell Transplantation","2026-05-03",{"date":87,"type":32},"2026-05-07",{"date":89,"type":32},"2025-09-01",{"date":91,"type":19},"2027-09",{"name":93,"class":39},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":20,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100588067","phase-2-magic-ruxolitinib-for-agvhd-100588067","NCT06936566","MAGIC Ruxolitinib for aGVHD","Phase 2 Study of Ruxolitinib-Based Primary Treatment for Acute GVHD","MAGIC V","Inclusion Criteria:\n\n* Standard risk cohort: Minnesota standard risk GVHD (except patients with grade I \\[\\\u003C50% BSA rash\\])\n* High risk cohort: Minnesota high risk GVHD 3 GVHD that developed after DLI for mixed chimerism or poor graft function is allowed\n* No prior systemic acute GVHD treatment. Topical or non-absorbed steroids are permitted.\n* All donor types, HLA-matches, conditioning regimens, or GVHD prophylaxis strategies are acceptable\n* ≥18 years of age\n* Standard risk cohort: Hematopoietic engraftment with absolute neutrophil count (ANC) ≥ 1000\u002FμL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.\n* High risk cohort: Hematopoietic engraftment with ANC ≥ 500\u002FuL and platelet count ≥20,000. Use of growth factor supplementation and transfusions to maintain adequate hematologic parameters are allowed.\n\nExclusion Criteria:\n\n* Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry\n* Prior use of ruxolitinib to treat GVHD at any time\n* Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression\n* Relapse prior to development of GVHD unless subsequently in remission for at least 3 months\n* GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval\n* Uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)\n* Severe organ dysfunction within 3 days of enrollment including requirement for dialysis, mechanical ventilation, continuous BiPAP, or continuous high flow oxygen by nasal cannula, or total bilirubin ≥ 3x upper limit of normal not due to GVHD.\n* A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment (except for mild oral or ocular GVHD)\n* Corticosteroids \\>10 mg\u002Fday methylprednisolone (or other methylprednisolone equivalent, MPE) for any indication within 5 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions\u002FIV meds\n* Participation in clinical trials using experimental agents not approved by the FDA for any indication within 14 days of enrollment or five half-lives, whichever is longer provided any prior adverse events have improved to ≤grade 1\n* Patients who are pregnant or nursing\n* History of allergic reaction to ruxolitinib or any JAK inhibitor",{"count":103,"type":19},98,[78],"This clinical trial will study ruxolitinib-based treatment of acute graft-versus-host-disease (GVHD) that developed following allogeneic hematopoietic cell transplant. Acute GVHD occurs when donor cells attack the healthy tissue of the body. The most common symptoms are skin rash, jaundice, nausea, vomiting, and\u002For diarrhea. The standard treatment for GVHD is high dose steroids such as prednisone or methylprednisolone, which suppresses the donor cells, but sometimes there can be either no response or the response does not last. In these cases, the GVHD can become dangerous or even life threatening. High dose steroid treatment can also cause serious complications. Researchers have developed a system, called the Minnesota risk system, to help predict how well the GVHD will respond to steroids based on the symptoms present at the time of diagnosis. The Minnesota risk system classifies patients with newly diagnosed acute GVHD into two groups with highly different responses to standard steroid treatment and long-term outcomes. This protocol maximizes efficiency because all patients with grade II-IV GVHD are eligible for screening and treatment is assigned according to patient risk. Patients with lower risk GVHD, Minnesota standard risk, have high response rates to steroid treatment. In this trial the researchers will test whether ruxolitinib alone is as effective (non-inferior) as steroid-free therapy and safe. Patients will be randomized to two different doses of ruxolitinib to identify the dose which maximizes efficacy while minimizing toxicities such as hematologic and infectious toxicities. Patients with higher risk GVHD, Minnesota high risk, have unacceptable outcomes with systemic corticosteroid treatment alone and the researchers will test whether adding ruxolitinib, a proven effective second line GVHD treatment, can improve outcomes when added to systemic corticosteroids as first line treatment.",[107,108,109],"Acute Graft-versus-host Disease","Allogeneic Bone Marrow Transplantation","Adverse Effects","2026-03-18",{"date":112,"type":32},"2026-03-23",{"date":114,"type":32},"2025-05-14",{"date":116,"type":19},"2028-04-14",{"name":118,"class":39},"John Levine",14,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":20,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":40},"100598375","phase-1-a-phase-ib-clinical-study-of-ac-003-capsules-in-subjects-with-agvhd-100598375","NCT07070674","A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.","A Phase Ib Clinical Trial to Investigate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetic Profile of AC-003 Capsules in Patients With Acute GraftVersus-Host Disease (aGVHD)","Inclusion Criteria:\n\n1. Male or female patients age ≥ 18 years.\n2. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) from any donor source (including matched unrelated donor, haplo-identical).\n3. Diagnosis of grade II-IV aGVHD as per MAGIC criteria within 100 days after HSCT.\n4. Diagnosis of steroid-refractory or steroid-dependent aGVHD in at least one of the following criteria:\n\n   1. Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   2. Not partial response after 7 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   3. Not complete response after 14 days of initial treatment with methylprednisolone 1\\~2 mg\u002Fkg\u002Fday (or equivalent corticosteroid)\n   4. Relapse of aGVHD when corticosteroid tapering.\n\nExclusion Criteria:\n\n1. Evidence of aGVHD relapsed.\n2. Evidence of chronic GVHD or overlap syndrome\n3. Receipt of more than one allogeneic HSCT\n4. Receipt of more than one systemic treatment for aGVHD in addition to corticosteroid\n5. Any corticosteroid therapy for indications other than aGvHD at doses \\>= 1 mg\u002Fkg\u002Fday methylprednisolone (or equivalent corticosteroid) within 7 days prior to enrolment\n6. Severe organ dysfunction unrelated to aGVHD\n7. Uncontrolled active infection (i.e., bacterial, fungal, or viral)",{"count":128,"type":19},24,[130],"PHASE1","The study was an open-label, single-arm, dose-escalation, Phase Ib, multi-center study to investigate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of AC-003 in patients with grade II-IV SR-aGVHD.",[133],"Acute Graft-versus-Host Disease","2026-03-13",{"date":136,"type":32},"2026-03-16",{"date":138,"type":32},"2024-07-25",{"date":140,"type":19},"2026-09-30",{"name":142,"class":143},"Accro Bioscience (Suzhou) Limited","INDUSTRY",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":20,"phases":154,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100457397","impact-of-exercise-on-the-complications-of-corticosteroids-in-patients-with-gvhd-the-restart-trial-100457397","NCT05236062","Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial","Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial","RESTART","Inclusion Criteria:\n\n* Over 18 years old; children under the age of 18 will be excluded due to rarity of disease\n* Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of .20 mg\u002Fkg or greater for the first time since transplant\n* Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute\n* Physician's clearance to participate in moderate-vigorous intensity exercise\n* Speak English\n* Currently participate in less than 60 minutes of structured exercise\u002Fweek\n* Willing to travel to Dana-Farber Cancer Institute for necessary data collection\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Have a plan for hospital admission within the next 13 weeks at the time of recruitment\n* If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible\n* Pre-existing musculoskeletal or cardiorespiratory conditions\n* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease\n* Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy\n* Patients with other active malignancies\n* Participate in more than 60 minutes of structured exercise\u002Fweek\n* Unable to travel to Dana-Farber Cancer Institute for necessary data collection\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.",{"count":153,"type":19},36,[22],"This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant.\n\nThe names of the study interventions involved in this study are:\n\n* Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program\n* Attention control (AC) - Home-based stretching program",[157,56,158],"Graft Vs Host Disease","Chronic Graft-versus-host-disease",[157,56,158,160,161],"Corticosteroids","Allogeneic stem cell transplant","2026-03-09",{"date":164,"type":32},"2026-03-11",{"date":166,"type":32},"2022-04-14",{"date":168,"type":19},"2027-09-09",{"name":170,"class":39},"Dana-Farber Cancer Institute",2,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":20,"phases":181,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":40},"100596591","phase-3-effect-of-stem-cell-infusion-time-on-agvhd-in-patients-with-hematological-malignancies-post-ucbt-100596591","NCT07047456","Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT","Prospective Randomized Controlled Phase III Clinical Study on the Impact of Stem Cell Infusion Timing on the Incidence of Acute Graft-versus-host Disease in Patients With Hematologic Malignancies Following Single-unit Umbilical Cord Blood Transplantation","Inclusion Criteria:\n\n* Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited;\n* Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation;\n* Participants who are proposed to receive sUCBT for the first time;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* No serious organ failure and active infection;\n* Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;\n* Each subject must sign an informed consent form (ICF) indicating that he\u002F she understands the purpose and procedures of the study and is willing to participate in the study; in view of the subject's condition, if the participant's own signature is not conducive to the treatment of his\u002Fher condition, the ICF will be signed by the legal representative.\n\nExclusion Criteria:\n\n* Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;\n* Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;\n* Participants in other clinical studies that may affect aGVHD within 3 months;\n* Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).",{"count":180,"type":19},134,[182],"PHASE3","To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).",[26],[186],"Time of umbilical cord blood infusion","2025-12-17",{"date":189,"type":32},"2025-12-23",{"date":191,"type":32},"2025-07-11",{"date":193,"type":19},"2027-12-31",{"name":195,"class":196},"Anhui Provincial Hospital","OTHER_GOV",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":20,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":218,"leadSponsor":219,"locationsCount":40},"100614922","phase-1-first-line-jaktinib-for-acute-graft-versus-host-disease-agvhd-100614922","NCT07285889","First-Line Jaktinib for Acute Graft-Versus-Host Disease (aGVHD)","The Safety and Efficacy of Gecacitinib (Also Known as Jaktinib) Combined Glucocorticoids as First-line Treatment for Grade II-IV Acute Graft-versus-host Disease.","Inclusion Criteria:\n\n1. Voluntarily provide signed informed consent and be ≥18 years of age at the time of consent.\n2. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) using bone marrow, peripheral blood stem cells, or umbilical cord blood.\n3. Have received systemic glucocorticoid therapy for no more than 2 days prior to enrollment.\n4. Demonstrate clear myeloid and platelet engraftment: absolute neutrophil count (ANC) \\> 1.0 × 10⁹\u002FL and platelet count \\> 50 × 10⁹\u002FL (permitted use of growth factors or transfusion support).\n5. Clinical diagnosis of grade II-IV acute GVHD (aGVHD) per the MAGIC (Mount Sinai Acute GVHD International Consortium) criteria (Appendix 1).\n6. ECOG performance status of 0-2.\n7. Life expectancy \\> 4 weeks.\n8. Able to swallow tablets.\n9. Willing and able to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n1. History of ≥2 allo-HSCT procedures.\n2. Development of aGVHD following unplanned donor lymphocyte infusion (DLI) for relapse of underlying malignancy. Note: Planned DLI as part of the transplant protocol is permitted.\n3. Concurrent treatment with another JAK inhibitor. Note: Patients who previously discontinued JAK inhibitors due to toxicity (not refractory aGVHD) are eligible.\n4. Active bleeding.\n5. Diagnosed or suspected chronic GVHD.\n6. Uncontrolled active infection, defined as sepsis-induced hemodynamic instability or progressive symptoms\u002Fsigns\u002Fimaging findings attributable to infection. Asymptomatic or persistent fever alone is not exclusionary.\n7. unresolved toxicity or complications from allo-HSCT (excluding aGVHD).\n8. Clinically significant abnormalities that may compromise safety, including: a) Uncontrolled diabetes (fasting glucose \\>13.9 mmol\u002FL); b) Hypertension unresponsive to ≥2 agents (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg); c) Peripheral neuropathy ≥Grade 2 (per NCI CTCAE v5.0).\n9. Within 6 months prior to screening: NYHA Class III\u002FIV heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism.\n10. Arrhythmia requiring treatment or QTcB interval \\>480 ms at screening.\n11. Severe renal impairment (serum creatinine \\>1.5 × ULN) at screening.\n12. Pre-transplant history of gastrointestinal ulcers, gastrectomy, or intestinal resection that may impair drug absorption.\n13. Major surgery within 4 weeks prior to screening without full recovery.\n14. Cholestatic disorders or hepatic sinusoidal obstruction syndrome (SOS\u002FVOD) at screening (defined as persistent hyperbilirubinemia and organ dysfunction unrelated to GVHD).\n15. Active uncontrolled viral infections at screening: HBV: HBsAg⁺ with detectable HBV-DNA, or detectable HBV-DNA regardless of HBsAg status; HCV: Anti-HCV antibody⁺ with detectable HCV-RNA.\n16. History of active tuberculosis within 6 months prior to screening.\n17. Epilepsy or current use of psychotropic\u002Fsedative medications.\n18. Pregnancy, lactation, or intention to conceive; male patients unwilling to use condoms during treatment and for 2 days after the last dose.\n19. Other active malignancies (excluding the transplanted hematologic malignancy) within 5 years.\n20. Current use of anticoagulants or antiplatelet agents (except low molecular weight heparin).\n21. Any condition that, in the investigator's judgment, may compromise patient safety or protocol compliance.\n22. Known hypersensitivity to jaktinib, its analogs, or excipients.\n23. Participation in another interventional clinical trial within 4 weeks prior to screening.\n24. Investigator determination of unsuitability for the study.",{"count":205,"type":19},35,[130,78],"This study aims to evaluate the optimal dose (Recommended Phase 2 Dose, RP2D), preliminary safety, and efficacy of gecacitinib (also known as jaktinib) in combination with glucocorticoids as first-line therapy for patients with grade II-IV acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[26],[210,211,212,213],"acute graft-versus-host disease","Jaktinib","hematopoietic stem cell transplantation","gecacitinib","2025-12-03",{"date":216,"type":32},"2025-12-16",{"date":214,"type":32},{"date":193,"type":19},{"name":220,"class":39},"First Affiliated Hospital of Zhejiang University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":15,"minAge":227,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":20,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":40},"100607465","clinical-observation-on-the-efficacy-of-patient-donor-derived-probiotics-in-improving-intestinal-flora-disorder-in-patients-with-intestinal-acute-graft-versus-host-disease-agvhd-100607465","NCT07188909","Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)","Inclusion Criteria:\n\nSubjects eligible for this study must satisfy all of the following criteria:\n\n1. Age \\>50 years, regardless of gender;\n2. Scheduled for haploidentical hematopoietic stem cell transplantation;\n3. ECOG performance status score ≤2;\n4. Voluntarily participate and provide written informed consent.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following conditions will be excluded from this study:\n\n1. Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);\n2. Gastrointestinal disorders:\n\n   * Clostridioides difficile infection (CDI): Recurrent or refractory CDI;\n   * Other conditions: Ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS), diarrhea associated with dysbiosis, liver cirrhosis;\n3. Allergic or immune-mediated diseases:\n\n   Autoimmune hepatitis, systemic lupus erythematosus (SLE), ankylosing spondylitis, immune-mediated osteoarthritis, allergic dermatitis, immune thrombocytopenic purpura (ITP);\n4. Antibiotic usage within 7 days prior to enrollment.","50 Years",{"count":229,"type":19},10,[22],"To clinically evaluate the efficacy of patient- and\u002For donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.",[82],"NOT_YET_RECRUITING","2025-09-16",{"date":236,"type":32},"2025-09-23",{"date":238,"type":19},"2025-09-15",{"date":240,"type":19},"2026-03-04",{"name":242,"class":39},"Institute of Hematology & Blood Diseases Hospital, China",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":15,"minAge":250,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":20,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":40},"100583753","phase-2-anti-cd25-rhmab-for-agvhd-prevention-in-high-risk-adults-using-the-dagoat-model-100583753","NCT06880419","Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model","A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model","Inclusion Criteria:\n\n1. Age ≥ 16 years, regardless of gender.\n2. Patients with hematologic disorders who are scheduled to receive allo-HSCT.\n3. Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who have received a second or multiple transplants.\n2. Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.\n3. Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.","16 Years",{"count":252,"type":19},174,[78],"To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[133],"2025-08-04",{"date":258,"type":32},"2025-08-08",{"date":260,"type":32},"2025-03-03",{"date":262,"type":19},"2026-12-31",{"name":242,"class":39},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":20,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":40},"100473325","phase-1-leflunomide-in-combination-with-steroids-for-the-treatment-of-acute-graft-versus-host-disease-after-donor-stem-cell-transplant-for-hematologic-malignancies-100473325","NCT05443425","Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies","Pilot Trial of Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age \\>= 18 years old\n* Karnofsky performance status \\>= 70\n* Clinically suspected grade II-IV aGvHD based on Mount Sinai Acute GVHD International Consortium (MAGIC) Consensus criteria occurring after allogeneic hematopoietic cell transplantation (HCT) and GvHD prophylaxis regimen. Grade I acute (a)GvHD requiring systemic steroids is allowed. Clinical suspicion of aGvHD by the treating physician is sufficient, provided that alternative diagnosis of drug effects or infection are adequately ruled out\n\n  * Note: HCT from any donor (related or unrelated with any degree of human leukocyte antigen \\[HLA\\] matching) and any graft source (bone marrow, peripheral blood stem cells, or cord blood) for hematologic malignancy or disorder. Recipient of myeloablative and reduced-intensity conditioning regimens are eligible\n* Biopsy of acute GvHD target organ is recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 72 hours from start of steroids are not permitted to participate\n* Evidence of myeloid engraftment (e.g., absolute neutrophil count \\[ANC\\] \\>= 0.5 x 10\\^9\u002FL for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed\n* No prior systemic treatment for treatment of acute GvHD except for a maximum of 72 hours of prednisone =\\\u003C 2 mg\u002Fkg\u002Fday (or intravenous \\[IV\\] methylprednisone equivalent). Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible\n* Patients should be able to swallow and retain oral medication\n* Total bilirubin =\\\u003C 2 X ULN (unless has Gilbert's disease or aGvHD within 3 days of enrollment) (performed within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (performed within 14 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN (performed within 14 days prior to day 1 of protocol therapy)\n* Creatinine clearance of \\>= 50 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Recipient of more than one allogeneic HCT\n* Received more than 3 days of systemic corticosteroid for treatment of aGvHD\n* Presence of GVHD overlap syndrome\n* Prior treatment with leflunomide\n* Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period\n* Use of other drugs for treatment of acute GvHD\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (leflunomide or cholestyramine)\n* Clinically significant uncontrolled illness\n* Patients on dialysis\n* Patient requiring ventilator support\n* Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributed to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection\n* Known history of immunodeficiency virus (HIV) infection\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment, HBV deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) must be undetectable upon testing. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (i.e., hepatitis B surface antigen negative, surface antibody positive) may be used for purpose of eligibility and test do not need to be repeated. Subjects within prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown must have results confirming immune status before enrolment\n* Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allogeneic (allo)-HCT was performed\n* Severe organ dysfunction unrelated to underlying GvHD, including:\n\n  * Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction)\n  * Clinically significant uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy\n  * Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen\n* Non-hematologic malignancy within the past 3 years aside from the following exceptions:\n\n  * Adequately treated basal cell or squamous cell skin cancer\n  * Carcinoma in situ of the cervix\n  * Prostate cancer \\\u003C Gleason Grade 6 with a stable prostate specific antigen (PSA)\n  * Successfully treated in situ carcinoma of the breast\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, social\u002F psychological issues, etc.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":272,"type":19},18,[130],"This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.",[26,276],"Hematopoietic and Lymphoid System Neoplasm","2025-07-02",{"date":279,"type":32},"2025-07-04",{"date":281,"type":32},"2023-06-16",{"date":283,"type":19},"2027-01-05",{"name":285,"class":39},"City of Hope Medical Center",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":15,"minAge":293,"maxAge":50,"enrollmentInfo":294,"targetDuration":4,"studyType":20,"phases":296,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100538734","phase-3-effect-of-stem-cell-infusion-time-on-agvhd-in-patients-with-nonmalignant-hematologic-diseases-100538734","NCT06294691","Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases","A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;\n* Patients who are proposed to receive allo-PBSCT for the first time;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* No serious organ failure and active infection;\n* Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;\n* Each subject must sign an informed consent form (ICF) indicating that he\u002F she understands the purpose and procedures of the study and is willing to participate in the study; in view of the patient's condition, if the patient's own signature is not conducive to the treatment of his\u002Fher condition, the ICF will be signed by the legal representative.\n\nExclusion Criteria:\n\n* Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;\n* Pregnant patients;\n* Patients and\u002For authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;\n* Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;\n* Participants in other clinical studies that may affect aGVHD within 3 months;\n* Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).","12 Years",{"count":295,"type":19},198,[182],"To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)",[107],[300],"Time of stem cell infusion","2025-06-23",{"date":303,"type":32},"2025-06-26",{"date":305,"type":32},"2024-03-15",{"date":307,"type":19},"2026-08-31",{"name":195,"class":196},6,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":15,"minAge":317,"maxAge":74,"enrollmentInfo":318,"targetDuration":4,"studyType":20,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":171},"100510043","phase-3-mini-dose-mtx-plus-standard-dose-steroid-for-the-initial-treatment-of-acute-gvhd-100510043","NCT05921305","Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD","Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease","Inclusion Criteria:\n\n1. Patients who are fully informed and sign informed consent by themselves or their guardians;\n2. Patients receiving first allogeneic hematopoietic stem cell transplantation;\n3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;\n4. KPS\\>60, Estimated survival \\>3 months;\n5. No serious organ damage:\n\n   1. ANC in peripheral blood is greater than 0.5×109\u002Fl\n   2. Creatinine \\\u003C 1.5mg\u002Fdl\n   3. Cardiac ejection index \\> 55%\n\nExclusion Criteria:\n\n1. Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease;\n2. Patients with uncontrollable active infection;\n3. Patients with recurrence of primary malignant hematopathy;\n4. Expected survival is less than 3 months\n5. Patients who have histories of severe allergic reactions\n6. Pregnant or lactating women\n7. The researcher judges that there are other factors that are not suitable for participating\n8. Patients who received donor lymphocyte infusion","15 Years",{"count":319,"type":19},218,[182],"This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg\u002Fkg\u002Fday compared to methylprednisolone 2mg\u002Fkg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.",[26],"2025-05-28",{"date":325,"type":32},"2025-06-03",{"date":327,"type":32},"2023-08-03",{"date":140,"type":19},{"name":330,"class":39},"Peking University People's Hospital",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":20,"phases":341,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100589042","early-phase-1-a-study-of-imsc-for-the-prevention-of-acute-graft-versus-host-disease-after-allogeneic-hematopoietic-stem-cell-transplantation-100589042","NCT06949267","A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","A Prospective, Randomized Controlled Study of Human Induced Pluripotent Stem Cell-derived Mesenchymal Stromal Cells (iMSC) for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;\n* No gender restrictions and age between 14-70 years old；\n* Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；\n* Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP\\\u003C 0.14 at +7d, another test was performed at +14d)；\n* Estimated survival≥ 24 weeks；\n* Eastern Cooperative Oncology Group（ECOG）≤ 2 points and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)≤ 3 points；\n* Subjects were be treated within 5 days after enrollment；\n* Informed consent and willingness to participate in the study.\n\nExclusion Criteria:\n\n* Serious organ dysfunction such as organ failure after allogeneic HSCT;\n* Received more than once HSCT (including autologous transplants);\n* Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;\n* Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;\n* Primary malignant hematologic disease was not remission;\n* Within 6 months prior to enrollment, subjects had other diseases or their physiological conditions may interfere the study results, or had life-threatening complications;\n* Those who are suffering mental or neurological illnesses, unable to express will correctly;\n* Those with active malignant solid tumors within 5 years prior to participation in this study, with the exception of radically treated cervical cancer, in situ limited prostate cancer, and nonmelanoma skin cancer;\n* Subjects known to be potentially allergic or highly sensitized to the cell therapy in the study protocol;\n* Have participated or are participating in another clinical trial within one month prior to enrollment;\n* Those who are judged by the investigator to be unsuitable for participation in this clinical trial.","70 Years",{"count":340,"type":19},56,[342],"EARLY_PHASE1","An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.",[133],[346,347,348,349],"iMSC","III-IV aGVHD","allogeneic hematopoietic stem cell transplantation","prophylaxis","2025-04-21",{"date":352,"type":32},"2025-04-29",{"date":354,"type":19},"2025-06-01",{"date":356,"type":19},"2028-03-31",{"name":358,"class":39},"Ruijin Hospital",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":338,"enrollmentInfo":366,"targetDuration":4,"studyType":20,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100588434","phase-1-a-trial-to-evaluate-the-safety-and-efficacy-of-ncr102-in-subjects-with-agvhd-100588434","NCT06941350","A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD","A Phase I\u002FII Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)","Inclusion Criteria:\n\n* Age\\>18 years and \\\u003C70 years old (including threshold), gender not limited；\n* Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD)；\n* Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)；\n* Failed to second-line aGVHD treatment;\n* Subjects will receive NCR102 injection treatment within 3 days after enrollment;\n* Voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n* Subjects have lung disease, and investigators have determined that they are not suitable for the study;\n* Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;\n* Subjects with signs\u002Fsymptoms of chronic GVHD;\n* Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;\n* Eastern Cooperative Oncology Group(ECOG)\\>3；\n* Subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications；\n* Subjects had active malignant solid tumors within the past 5 years；\n* Subjects had a known history of severe allergies to blood products, or heterologous proteins.",{"count":128,"type":19},[130,78],"Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.",[133],[371,372,373],"SR-aGVHD","NCR102","second-line treatment failure","2025-04-16",{"date":376,"type":32},"2025-04-23",{"date":378,"type":19},"2025-04-28",{"date":380,"type":19},"2027-05-30",{"name":382,"class":143},"Nuwacell Biotechnologies Co., Ltd.",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":20,"phases":392,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":40},"100585610","phase-2-efficacy-of-human-chorionic-gonadotropin-in-acute-gvhd-treatment-100585610","NCT06904599","Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment","Evaluation of Human Chorionic Gonadotropin for the Treatment of Acute Graft-versus-host Disease in Patients With Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Any gender.\n* Post-allogeneic transplantation status (haploidentical or identical) of hematopoietic cells.\n* Presenting recently onset aGVHD, grades 2 to 4, and requiring systemic steroid use as determined by the treating physician.\n* Have not received steroids (Prednisone ≥1 mg\u002Fkg\u002Fday or equivalent dose of another steroid) for more than 3 days in the last week.\n* Willing to participate in the study by signing informed consent.\n* If the subject is female and has the potential to procreate (a woman is considered fertile from menarche to postmenopausal stage or after undergoing a permanent contraceptive method), she agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: oral hormonal contraception, intrauterine device, barrier methods (diaphragm, male or female condom, and foam, sponge, or spermicide film), or agrees to remain abstinent. Women who have been postmenopausal for more than a year, undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are not considered to have reproductive potential.\n* If the subject is male, he agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: male condom, or remain abstinent.\n\nExclusion Criteria:\n\n* Arterial or venous thrombosis in the past 3 months.\n* History of thromboembolic disease requiring full-dose anticoagulation.\n* Diagnosis of active malignant disease.\n* Uncontrolled infection.\n* Chronic use of supplemental therapy with sex hormones (estrogen, progesterone, and\u002For testosterone).\n* Women with a positive pregnancy test at the time of the initial evaluation.\n* Women or men of reproductive age who are unwilling to take appropriate precautions to avoid an unwanted pregnancy from the start of the protocol until 30 days after the protocol.",{"count":391,"type":19},20,[78],"Graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. The standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. The administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.",[26],[396,397],"Acute GVHD","human chorionic gonadotropin","2025-03-31",{"date":400,"type":32},"2025-04-03",{"date":402,"type":32},"2025-02-01",{"date":404,"type":19},"2026-01-31",{"name":406,"class":39},"Hospital Universitario Dr. Jose E. Gonzalez",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":338,"enrollmentInfo":415,"targetDuration":4,"studyType":20,"phases":416,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":171},"100573734","phase-1-universal-cnk-ut-therapy-for-refractory-agvhd-100573734","NCT06750133","Universal CNK-UT Therapy for Refractory aGVHD","A Study of Universal CNK-UT Cell Injection in Patients With Refractory Acute Graft-versus-host Disease","CNK-UT","Inclusion Criteria:\n\n1. Aged 14-70 years, male or female;\n2. Participants diagnosed with grade II\\~IV steroid-refractory\u002Fresistant or steroid-dependent aGVHD after allogeneic hematopoietic stem cell transplantation.\n3. ECOG physical status score 0\\~3;\n4. Estimated life expectancy \\> 12 weeks;\n5. Female participants of childbearing age must undergo a serum or urine pregnancy test before enrollment, and the results must be negative, and agree to take acceptable measures to minimize the possibility of pregnancy during the trial; For female participants of childbearing age or male participants whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the study and for at least 6 months following the last dose of the study cells infusion.\n6. Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.\n\nExclusion Criteria:\n\n1. Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and \u002F or radical resection of carcinoma in situ.\n2. Participants with a history of organ transplantation;\n3. Participants who have previously undergone more than one allogeneic hematopoietic stem cell transplantation.\n4. Uncontrolled hypertension as determined by principal investigator, a history of hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart failure (New York Heart Association classification III-IV); symptomatic or poorly controlled arrhythmias; a history of congenital long QT syndrome or a corrected QT interval (QTc) \\> 500 ms at screening (calculated using the Fridericia method)..\n5. Systemic diseases deemed unstable by principal investigator include, but are not limited to, severe pulmonary, hepatic, renal, or metabolic disorders that require pharmacological intervention (excluding complications related to allogeneic hematopoietic stem cell transplantation).\n6. Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis infection.\n7. Severe infections that are active or poorly controlled clinically.\n8. Participants who have received treatment from other clinical trials within 12 weeks prior to the initiation of the study.\n9. Participants who have previously used any gene therapy products prior to the initiation of the study.\n10. Allergic to components of CNK-UT injection.\n11. Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.\n12. Women who are pregnant or breastfeeding, as well as male or female participants who have planned for birth within 1 year after receiving medication.\n13. Uncontrolled\u002Funcorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and\u002For uncertainty in survival assessments.\n14. Other situations that the participant is identified by the investigator as unsuitable to participate in the study.",{"count":5,"type":19},[130],"This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory\u002Fresistant or steroid-dependent aGVHD.",[133],[420,421,422,423,424],"CNK-UT cell","aGVHD","allo-HSCT","steroids refractory","cellular therapy","2024-12-25",{"date":427,"type":32},"2024-12-27",{"date":429,"type":32},"2024-12-14",{"date":431,"type":19},"2026-06-30",{"name":220,"class":39},{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":48,"sex":15,"minAge":16,"maxAge":74,"enrollmentInfo":440,"targetDuration":442,"studyType":53,"phases":4,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":40},"100570535","tissue-resident-immune-cell-subsets-in-agvhd-100570535","NCT06708507","Tissue-resident Immune Cell Subsets in aGVHD","A Prospective Study on the Correlation Between Tissue-resident Immune Cell Subsets and Graft-versus-host Disease Following Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Age 16-65 years old\n3. Clinically diagnosed with GVHD for the first time\u002Freceiving GVHD treatment.\n\nExclusion Criteria:\n\n1. Have a history of other tumors\n2. With poor compliance or mental disorders\n3. Infected with HIV and HCV\n4. With uncontrolled HBV infection\n5. With other autoimmune diseases\n6. Those who are judged by the researcher to be unsuitable to participate in this study",{"count":441,"type":19},40,"100 Days","This is a prospective study investigating the role of tissue-resident immune cell subsets in the occurrence and progression of graft-versus-host disease following hematopoietic stem cell transplantation. Approximately 40 subjects(including 20 grade 3-4 aGVHD patients and 20 grade 1-2 aGVHD patients ).",[133,445],"Hematopoietic Stem Cell Transplantation","2024-11-25",{"date":448,"type":32},"2024-11-27",{"date":450,"type":32},"2024-11-16",{"date":452,"type":19},"2025-05-31",{"name":454,"class":39},"Nanfang Hospital, Southern Medical University",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":463,"enrollmentInfo":464,"targetDuration":4,"studyType":20,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":4},"100561720","a-clinical-study-of-bacillus-coagulans-in-acute-graft-versus-host-disease-after-hematopoietic-stem-cell-transplantation-100561720","NCT06593834","A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease After Hematopoietic Stem Cell Transplantation","A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease (aGVHD) After Hematopoietic Stem Cell Transplantation","aGVHD；BAT","Inclusion Criteria:\n\n1. Patients are fully aware of the study, voluntarily participate and sign informed consent;\n2. Age: ≥18 years old;\n3. Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC).\n\nExclusion Criteria:\n\n1. Refused to participate in this clinical study;\n2. Unable to take the drug orally;\n3. Allergic to Bacillus coagulans;\n4. People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients.","80 Years",{"count":465,"type":19},286,[22],"To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation",[107],"2024-09-22",{"date":471,"type":32},"2024-09-25",{"date":473,"type":19},"2024-09-27",{"date":475,"type":19},"2026-04-30",{"name":477,"class":39},"Yamin Fan",{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":20,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100553782","low-dose-cyclophosphamide-or-cni-in-the-prevention-of-acute-graft-versus-host-disease-after-gdli-100553782","NCT06490562","Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI","A Prospective Multicenter Randomized Controlled Clinical Trial Protocol for the Efficacy and Safety of Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI","Inclusion Criteria:\n\n* Subjects eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Patients with malignant hematological diseases undergo haploid\u002Fsibling incomplete matching\u002Funrelated donor transplantation;\n  2. Recurrence after transplantation (morphological, extramedullary, or molecular recurrence);\n  3. Plan to administer granulocyte colony-stimulating factor mobilization donor lymphocyte infusion (gDLI) for treatment;\n  4. No age, gender, or race restrictions;\n  5. The physical condition assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points;\n  6. The patient or their authorized representative agrees to participate in the clinical trial and signs an informed consent form.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria are not eligible for inclusion in this study:\n\n  1. Siblings of matched donor transplant;\n  2. Patients with other malignant tumors that require treatment;\n  3. There are active infections, such as hepatitis B, hepatitis C, tuberculosis, etc;\n  4. HIV serological reaction was positive;\n  5. Suffering from mental illness or other conditions that cannot comply with research, treatment, and monitoring requirements;\n  6. Pregnant patients or patients who are unable to take appropriate contraceptive measures during treatment;\n  7. Active heart disease is defined as one or more of the following:\n\n     1. Have a history of uncontrolled or symptomatic angina pectoris;\n     2. Myocardial infarction less than 6 months prior to enrollment in the study;\n     3. A history of arrhythmia requiring medication treatment or severe clinical symptoms;\n     4. Uncontrolled or symptomatic congestive heart failure (\\>NYHA level 2);\n     5. The ejection fraction is below the lower limit of the normal range.\n  8. Individuals who are allergic to any medication or component such as Cy, CNI, etc;\n  9. The researchers believe that it is not suitable for participants.",{"count":486,"type":19},66,[22],"Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological\u002Fextramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.",[107],"2024-06-28",{"date":492,"type":32},"2024-07-08",{"date":494,"type":19},"2024-07",{"date":496,"type":19},"2028-12",{"name":242,"class":39},{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":20,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":40},"100553018","phase-2-effectiveness-and-safety-of-a-single-center-clinical-study-on-a-cd25-monoclonal-antibody-containing-gvhd-prophylaxis-scheme-to-reduce-the-incidence-of-severe-acute-gvhd-after-umbilical-cord-blood-transplantation-for-malignant-hematologic-diseases-100553018","NCT06480630","Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases","Inclusion Criteria:\n\n* Malignant hematologic disorders;\n* Patients undergoing UCBT;\n* Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.\n\nExclusion Criteria:\n\n* Non-malignant hematologic disorders;\n* History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* Uncontrolled bacterial, viral, or fungal infections. \"Uncontrolled\" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;\n* HIV infection or active hepatitis B or C virus infection;\n* Pregnant or lactating women;\n* Substance abusers; subjects with uncontrolled psychiatric disorders; individuals with cognitive dysfunction;\n* Participation in similar clinical studies within the past 3 months;\n* Subjects deemed unsuitable by the investigator (e.g., those expected to be unable to adhere to treatment due to financial constraints).",{"count":505,"type":19},39,[78],"Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.",[26,509],"Malignant Hematologic Neoplasm","2024-06-25",{"date":490,"type":32},{"date":513,"type":19},"2024-07-01",{"date":515,"type":19},"2027-06-30",{"name":195,"class":196},{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":20,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":534,"leadSponsor":536,"locationsCount":4},"100552501","phase-2-combination-of-steroid-and-humanized-cd25-monoclonal-antibody-as-first-line-therapy-for-agvhd-100552501","NCT06473909","Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD","An Exploratory Clinical Study on the Efficacy and Safety of Humanized CD25 Monoclonal Antibody Combined With Glucocorticoid in the First-line Treatment of Acute Graft-versus-host Disease (aGVHD) After Allo-HSCT","Inclusion Criteria:\n\n* ( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation.\n\n( 2 ) older than or equal to 18 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. The informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent will be signed by the legal guardian or the patient 's immediate family.\n\nExclusion Criteria:\n\n* • (1) diagnosed as VOD\u002FSOS.\n\n  * (2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment;\n  * (3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 5 xthe upper limit of normal (ULN) or serum total bilirubin \\> 2.5 x ULN.\n  * (4) has end-stage renal impairment with a creatinine clearance less than 10 mL\u002Fmin.\n  * (5) has both moderate hepatic insufficiency AND moderate renal insufficiency;\n  * (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments;\n  * (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).\n  * (8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring;\n  * (9) unable or unwilling to sign the consent form;\n  * (10) patients with other special conditions assessed as unqualified by the investigator",{"count":391,"type":19},[78],"The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.",[26],[421,529,530],"humanized CD25 monoclonal antibody","glucocorticoid","2024-06-24",{"date":510,"type":32},{"date":513,"type":19},{"date":535,"type":19},"2025-12-31",{"name":242,"class":39},{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":15,"minAge":544,"maxAge":74,"enrollmentInfo":545,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":558,"locationsCount":4},"100545787","study-on-the-serum-metabolic-markers-and-early-complications-after-allo-hsct-cohort-study-100545787","NCT06386445","Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study","Study on the Serum Metabolic Markers and Early Complications After Allogeneic Hematopoietic Stem Cell Transplantation in Hemaotological Diseases： Cohort Study","Inclusion Criteria:\n\n* Age ≤ 65 years old;\n\nGender unlimited;\n\nNormal heart and kidney function before transplantation;\n\nPatients with indications for allogeneic hematopoietic stem cell transplantation.\n\nExclusion Criteria:\n\n* CREA or BUN higher than the normal upper limit value before transplantation;\n\nIndividuals with a history of arrhythmia, heart failure, or PCI stent implantation prior to transplantation;\n\nPatients with mental illness;\n\nThose who are unwilling to sign informed consent.","0 Years",{"count":546,"type":19},500,"This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications.",[549,26,550,551],"Stem Cell Transplant Complications","Acute Kidney Injury","Major Adverse Cardiac Events","2024-04-23",{"date":554,"type":32},"2024-04-26",{"date":556,"type":19},"2024-05-01",{"date":262,"type":19},{"name":559,"class":39},"First Affiliated Hospital Xi'an Jiaotong University"]