[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steroid-refractory-acute-graft-versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steroid-refractory-acute-graft-versus-host-disease":132},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,80,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100636975","phase-2-moxibustion-for-steroid-refractory-acute-graft-versus-host-disease-after-allogeneic-hematopoietic-stem-cell-transplantation-100636975",false,"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.","ALL","14 Years","65 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Steroid-Refractory Acute Graft-Versus-Host Disease","Acute Graft-Versus-Host Disease","Graft-Versus-Host Disease","Allogeneic Hematopoietic Stem Cell Transplantation","RECRUITING","2026-05-03",{"date":34,"type":35},"2026-05-07","ACTUAL",{"date":37,"type":35},"2025-09-01",{"date":39,"type":21},"2027-09",{"name":41,"class":42},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100551621","phase-4-study-of-efficacy-and-safety-of-ruxolitinib-in-patients-with-grade-ii-to-iv-steroid-refractory-acute-graft-vs-host-disease-100551621","NCT06462469","Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease","A Single-arm, Multi-center Study of Ruxolitinib for the Treatment of Chinese Patients With Grade II-IV Corticosteroid-refractory Acute Graft Versus Host Disease","Key Inclusion criteria\n\n* Male or female Chinese participants aged 12 or older at the time of informed consent. Written informed consent from participant, parent or legal guardian.\n* Able to swallow tablets.\n* Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood.\n* Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive therapy.\n* Evident myeloid and platelet engraftment (confirmed within 48 hours prior to study treatment (ruxolitinib) start):\n* Confirmed diagnosis of steroid refractory aGvHD defined as participants administered systemic corticosteroids (methylprednisolone at least 1 mg\u002Fkg\u002Fday \\[or equivalent prednisone dose at least 1.25 mg\u002Fkg\u002Fday\\]), given alone or combined with calcineurin inhibitors (CNI) and either:\n\n  1. Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of systemic corticosteroid +\u002F- CNI for the treatment of Grade II to IV aGvHD. OR\n  2. Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of systemic corticosteroid +\u002F-CNI for the treatment of Grade II to IV. OR\n  3. Participants who fail corticosteroid taper defined as fulfilling either one of the following criteria:\n\n     * Requirement for an increase in the corticosteroid dose to methylprednisolone ≥ 1 mg\u002Fkg\u002Fday (or equivalent prednisone dose ≥ 1.25 mg\u002Fkg\u002Fday). OR\n     * Failure to taper the methylprednisolone dose to \\\u003C 0.5 mg\u002Fkg\u002Fday (or equivalent prednisone dose \\\u003C0.6 mg\u002Fkg\u002Fday) for a minimum of 7 days.\n\nKey Exclusion criteria\n\n* Has received more than one systemic treatment for steroid refractory aGvHD. Participants who received JAK inhibitor therapy for any indication after initiation of current alloSCT conditioning.\n* Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features.\n* Failed prior alloSCT within the past 6 months. Presence of relapsed primary malignancy after the alloSCT was performed.\n* Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.\n* SR-aGvHD occurring after non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n* Presence of significant respiratory disease, severely impaired renal function, clinically significant or uncontrolled cardiac disease, unresolved cholestatic and liver disorders (not attributable to aGvHD). Disorders and\u002For current therapy with medications that interfere with coagulation or platelet function.\n\nOther protocol-defined inclusion \u002F exclusion criteria may apply","12 Years","100 Years",{"count":54,"type":21},36,[56],"PHASE4","The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).",[59],"Steroid-refractory Acute Graft Versus Host Disease",[61,62,63,64,65,66,67,68],"SR-aGvHD","aGvHD","acute graft-versus-host disease","ruxolitinib","Chinese patients","corticosteroid-refractory","Grade II-IV","Grade II to IV","2025-11-23",{"date":71,"type":35},"2025-11-25",{"date":73,"type":35},"2024-07-04",{"date":75,"type":21},"2028-02-17",{"name":77,"class":78},"Novartis Pharmaceuticals","INDUSTRY",17,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":20},"100410847","phase-3-treatment-of-steroid-refractory-acute-graft-versus-host-disease-with-mesenchymal-stromal-cells-versus-best-available-therapy-100410847","NCT04629833","Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy","A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)","IDUNN","Inclusion Criteria:\n\n* Participant had a previous allogeneic HSCT as indicated for non-malignant (including inborn errors of metabolism, primary immunodeficiencies, haemoglobinopathies, and bone marrow failure syndromes) or haematological malignant disease, irrespective of human leukocyte antigen match\n* Participant has been clinically diagnosed with Grade II to IV aGvHD at the Screening Visit\n* Participant has experienced failure of previous first-line aGvHD treatment (ie, SR-aGvHD), defined as: a) aGvHD progression within 3 to 5 days of therapy onset with \\>= 2 mg\u002Fkg\u002Fday of prednisone equivalent or b) failure to improve within 5 to 7 days of treatment initiation with \\>= 2 mg\u002Fkg\u002Fday of prednisone equivalent or c) incomplete response after \\> 28 days of immunosuppressive treatment including at least 5 days with \\>= 2 mg\u002Fkg\u002Fday of prednisone equivalent\n* Participant has an estimated life expectancy \\> 28 days at the Screening Visit\n* Male or female participant who is \\>= 12 years of age at the Screening Visit\n\nExclusion Criteria:\n\n* Participant has overt relapse or progression or persistence of the underlying disease at the Screening Visit\n* Participant has received the last HSCT for a solid tumour disease\n* Participant has GvHD overlap syndrome at the Screening Visit\n* Participant has received systemic first line treatment for aGvHD other than steroids and a prophylaxis with other than calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, anti-thymocyte globulin (ATG), mycophenolate mofetil (MMF), methotrexate (MTX), and \u002F or cyclophosphamide before the Screening Visit\n* Participant has a known pregnancy (as confirmed by a positive pregnancy test at the Screening Visit) and or is breastfeeding at the Screening Visit\n* Participant has received treatment with any other investigational agent within 30 days or 5 half-lives (whichever is longer) before the Screening Visit (compliance to be confirmed for the period between the Screening Visit and the Baseline Visit at the Baseline Visit).",{"count":89,"type":21},210,[91],"PHASE3","The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and\u002For overall survival (OS) until Visit Month 24 in adult and adolescent subjects with steroid-refractory acute graft-versus-host disease (SR-aGvHD).",[94],"Steroid-refractory Acute Graft-versus-host Disease","2025-08-12",{"date":97,"type":35},"2025-08-13",{"date":99,"type":35},"2021-08-16",{"date":101,"type":21},"2030-08",{"name":103,"class":78},"medac GmbH",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":43},"100568133","phase-1-a-phase-iii-trial-of-vum02-injection-for-steroid-refractory-acute-graft-versus-host-disease-sr-agvhd-treatment-100568133","NCT06677255","A Phase I\u002FII Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment","A Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VUM02 Injection in the Treatment of Patients With Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD)","ESTEVS-I\u002FII","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible for this trial:\n\n1. Subjects aged 14-70 years (inclusive), male or female;\n2. Subjects who undergone allogeneic hematopoietic stem cell transplantation as indicated for hematological malignant disease, developed with grade II to IV aGvHD and failed standard first-line steroid therapy (that is, SR-aGvHD); 1) Definition of standard first-line steroid \u002Fglucocorticoid therapy: 1 mg\u002Fkg\u002Fday or 2 mg\u002Fkg\u002Fday of Methylprednisolone, or equivalent doses of steroids; 2) According to Thomas' Hematopoietic Cell Transplantation: Stem Cell Transplantation (5th edition), subjects who meet one of the following criteria are considered to have failed the standard first-line steroid \u002Fglucocorticoid therapy:\n\n   * a. Steroid resistance: Progression of aGvHD at Day 3 of first-line steroid therapy, or no improvement in aGvHD at Day 7, or incomplete remission of aGvHD at Day 14;\n   * b. Steroid dependence: failure to taper first-line steroid therapy or reactivation of aGvHD during taper;\n3. Investigator assessment: Expected survival ≥ 3 months;\n4. Clinical manifestations of aGvHD are rash and\u002For persistent nausea, vomiting, and\u002For diarrhea and\u002For cholestasis. For these clinical manifestations, other etiologies such as drug rash, intestinal infection, or hepatotoxicity syndrome have been ruled out;\n5. Subjects will be required to receive the investigational product within 3 days of enrollment;\n6. Subjects must give informed consent to the study prior to enrollment, with the subject himself\u002Fherself, or, the subject himself\u002Fherself and his\u002Fher legal guardian (only for subjects \\\u003C18 years of age), voluntarily signing a written informed consent form.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for this trial:\n\n1. Subjects with lung disease who, in the judgment of the investigator, are not appropriate to participate in the study;\n2. Serum virological examination shows positive results for active hepatitis B (hepatitis B core antibody positive and HBV-DNA in peripheral blood higher than the upper limit of normal), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the upper limit of normal), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody;\n3. Patients with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;\n4. Subjects who developed aGvHD after donor lymphocyte infusion therapy for recurrence of underlying hematologic malignancies;\n5. Patients complicated with brain lesion or who, in the judgment of the investigator, present with mental status changes;\n6. For subjects with aGvHD enrolled primarily for gastrointestinal symptoms, cytomegalovirus (CMV) enteritis, transplant-associated thrombotic microangiopathy (TA-TMA), and diarrhea due to gastrointestinal infections could not be ruled out clinically, as assessed by the investigator; pathological diagnostic criteria for CMV enteritis are: Large cells with basophilic inclusions in the intestinal mucosa; positive early\u002Flate CMV antigen by immunohistochemistry; positive CMV nucleic acid PCR in the homogenates of intestinal mucosal;\n7. Patients with coagulation dysfunction requiring anticoagulant therapy or antiplatelet therapy;\n8. Subject's renal function: Creatinine clearance \\\u003C30mL\u002Fmin; creatinine clearance is calculated using the Cockcroft-Gault formula: Ccr(ml\u002Fmin)=\\[(140-age)×body weight(kg)\\]\u002F(72×blood creatinine (mg\u002FdL), calculated results × 0.85 for females), and attention should be paid to the unit of creatinine during calculation of creatinine clearance;\n9. ECOG PS score \\> 3;\n10. Subjects who have evidence within 6 months prior to enrollment that suggests that they have other diseases or their physiological conditions may interfere with the evaluation results of this study, or have serious life-threatening complications, including but not limited to uncontrolled infection, pulmonary hypertension, severe cardiac insufficiency (NYHA Class III and IV), unstable angina pectoris or acute myocardial infarction, refractory hypertension (defined as the simultaneous use of 3 different types of antihypertensive drugs \\[one of which is the diuretic\\], and blood pressure remains higher than 160\u002F110 mmHg) (subject to the inpatient medical record diagnosis);\n11. Patients with active malignant solid tumor within 5 years before the study, except radically treated cervical cancer, localized prostate cancer in situ and non-melanoma skin cancer;\n12. Patients suffering from mental and neurological diseases and unable to correctly express their wishes;\n13. Patients who have received ≥ 1 therapy for aGvHD other than hormonal and protocol-recommended second-line agents prior to the study (subjects who received prophylactic drugs for aGvHD prior to the study may be included in this study);\n14. Patients with a known history of severe allergy to blood components or blood products, or to heterologous proteins;\n15. Breastfeeding women, or female subjects who have plans to become pregnant or donate eggs from the start of the study to the follow-up period, and male subjects (or their partners) who have plans to father a child or donate sperm from the start of the study to the follow-up period and are unwilling to take contraceptive measures;\n16. Patients who are not appropriate for participation in this clinical study as judged by the investigator;\n17. Patients who have participated in other clinical studies within the past one month.","70 Years",{"count":114,"type":21},149,[116,24],"PHASE1","It is a phase I\u002FII clinical study to evaluate the safety, tolerability and preliminary efficacy of VUM02 Injection in patients with acute graft-versus-host disease (aGvHD) who have failed systemic steroid therapy. VUM02 Injection (human umbilical cord-derived mesenchymal stromal \u002Fstem cells, hUC-MSC) is an off-the-shelf allogeneic cell therapy product comprising culture-expanded mesenchymal stromal \u002Fstem cells derived from the human umbilical cord tissue. The product is cryopreserved with the cell concentration of 5 x 10\\^6 cells\u002FmL. Patients with grade II to IV aGvHD who have failed systemic steroid therapy (i.e. patients with steroid-refractory aGvHD (SR-aGvHD)), will be recruited into this study. This study consists of two phases, a dose-escalation phase (phase I) and a dose-expansion phase (phase II).",[94],[63,120,61,121],"Mesenchymal stromal \u002Fstem cells","VUM02 Injection","NOT_YET_RECRUITING","2024-11-05",{"date":125,"type":35},"2024-11-06",{"date":127,"type":21},"2025-01",{"date":129,"type":21},"2028-12",{"name":131,"class":78},"Wuhan Optics Valley Vcanbiopharma Co., Ltd.","Steroid Refractory Acute Graft Versus Host Disease"]