[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-graft-vs-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-graft-vs-host-disease":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":4,"leadSponsor":37,"locationsCount":40},"100064662","natural-history-study-of-clinical-and-biological-factors-determining-outcomes-in-chronic-graft-versus-host-disease-100064662",false,"NCT00092235","Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease","* INCLUSION CRITERIA:\n\n  1. Any patient age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independently of age or underlying diagnosis\n  2. Patient or the patient's legal representative is able and willing to provide consent.\n\nEXCLUSION CRITERIA:\n\n1. Significant medical condition or any other significant circumstance that could in the PIs assessment affect the patient's ability to tolerate, comply, or complete the study\n2. Patients who in the PIs assessment have a life expectancy \\\u003C3 months.\n\n   Note: Because it is not always possible to make a clear clinical distinction between acute and chronic GVHD, patients with acute GVHD are not a-priori excluded until the possibility of chronic GVHD is reliably excluded on the basis of the clinical assessments in the cGVHD clinic.\n3. Pregnant women are excluded from this study because multiple tests would need to be excluded for safety of the patient and the fetus.\n\nInclusion Criteria for control subjects without cGVHD:\n\n* Age 1 and older\n* Patient has undergone Allo-HSCT\n* Patient or the patient's parent\u002Fguardian is able and willing to provide consent\n\nExclusion Criteria for control subjects without cGVHD:\n\n* Active GVHD\n* In the previous three months have received systemic immunosuppressant therapy for the treatment of GVHD\n* In the previous three months have received therapy for malignancy","ALL","1 Year","120 Years",{"count":19,"type":20},650,"ESTIMATED","OBSERVATIONAL","Background:\n\n* Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival.\n* Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant (alloHSCT) in North America and about 50% of patients who are transplanted develop cGVHD.\n* Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties. There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation.\n\nObjectives:\n\n* To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD.\n* To prospectively identify clinical and biological prognostic markers in patients with cGVHD\n* To develop clinically relevant cGVHD grading scales\n* To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation\n* To identify potential clinical and biological markers of cGVHD activity\n* To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects\n* To identify potential patients for cGVHD treatment protocols at the NCI and NIH\n\nEligibility:\n\n-Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis.\n\nDesign:\n\n* Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic.\n* Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm the diagnosis and\u002For rule-out other pathologic process (in adults only).\n* Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible",[24],"Chronic Graft vs. Host Disease",[26,27,28,29],"cGVHD-associated graft-versus-tumor effects (GVT)","Allo-HSCT controls","Leukapheresis","Natural History","RECRUITING","2026-06-27",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2004-10-26",{"name":38,"class":39},"National Cancer Institute (NCI)","NIH",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100579423","phase-4-study-of-efficacy-and-safety-of-ruxolitinib-in-chinese-participants-with-corticosteroid-refractory-chronic-graft-vs-host-disease-100579423","NCT06824103","Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease","A Single-arm Multi-center Study of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft Versus Host Disease After Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Male or female Chinese participants aged 12 or older at the time of informed consent\n* Able to swallow tablets.- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.\n* Evident myeloid and platelet engraftment:\n\n  * Absolute neutrophil count (ANC) \\>1,000\u002Fmm3 AND\n  * Platelet count ≥25,000\u002Fmm3\n\nNote: Use of growth factor supplementation and transfusion support is allowed during the trial, however, transfusion to reach a minimum platelet count for inclusion is not allowed during screening and at baseline.\n\n* Participants with clinically diagnosed cGvHD staging of moderate to severe according to NIH Consensus Criteria (Jagasia et al 2015) prior to Cycle 1 Day 1.\n\n  * Moderate cGvHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.\n  * Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3.\n* Participants currently receiving systemic corticosteroids for the treatment of cGvHD for a duration of \\\u003C 12 months prior to Cycle 1 Day 1, and have a confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin et al 2015) irrespective of the concomitant use of a calcineurin inhibitor, as follows:\n\n  * A lack of response or disease progression after administration of minimum prednisone 1 mg\u002Fkg\u002Fday for at least 1 week (or equivalent) OR\n  * Disease persistence without improvement despite continued treatment with prednisone at \\>0.5 mg\u002Fkg\u002Fday or 1 mg\u002Fkg\u002Fevery other day for at least 4 weeks (or equivalent) OR\n  * Increase to prednisone dose to \\>0.25 mg\u002Fkg\u002Fday after two unsuccessful attempts to taper the dose (or equivalent)\n* Participants has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n\nExclusion Criteria:\n\nFor a full list of exclusion criteria, refer to Section 5.2. Key exclusion criteria include\n\n* Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD.\n* Participants who have received ROCK2 inhibitors for cGvHD.\n* Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment\n\nNote: Participants receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.\n\n* Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1.\n* Failed prior alloSCT within the past 6 months from Cycle 1 Day 1.\n* Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed.\n* SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n\nOther protocol-defined inclusion\u002Fexclusion may apply.","12 Years","100 Years",{"count":51,"type":20},50,"INTERVENTIONAL",[54],"PHASE4","The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).",[57,24,58],"Graft vs. Host Disease","Corticosteroid-refractory Chronic Graft vs. Host Disease",[60,61,62,63,64,65,66,67,68],"cGvHD","GvHD","SR-cGvHD","ruxolitinib","INC424","Chinese adult","Pediatric","Corticosteroid","refractory","2026-06-04",{"date":71,"type":34},"2026-06-08",{"date":73,"type":34},"2025-09-09",{"date":75,"type":20},"2031-05-23",{"name":77,"class":78},"Novartis Pharmaceuticals","INDUSTRY",22,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":96,"locationsCount":4},"100481056","expanded-access-of-axatilimab-to-treat-a-single-patient-with-chronic-graft-versus-host-disease-gvhd-100481056","NCT05544032","Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","This program is being offered on a patient by patient basis and will require company, Institutional Review Board\u002FIndependent Ethics Committee and Single Patient IND approval.",[89],"Chronic Graft Vs. Host Disease",[89,91],"cGVHD","AVAILABLE","2025-10-03",{"date":95,"type":34},"2025-10-08",{"name":97,"class":78},"Incyte Corporation"]