[{"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,[8,43,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100648937","effects-of-axatilimab-on-skin-in-chronic-graft-versus-host-disease-100648937",false,"NCT07728708","Effects of Axatilimab on Skin in Chronic Graft-versus-Host Disease","Mapping On-Target Effects of Axatilimab in Human Chronic Graft-versus-Host Disease Skin: A Prospective Observational Mechanistic Study","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of chronic graft-versus-host disease (cGVHD) with skin involvement.\n* Planned initiation of axatilimab as part of routine clinical care (axatilimab arm) or not planning initiation of axatilimab as part of routine clinical care (control arm).\n* Able to undergo a skin biopsy at the time of enrollment.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Contraindication to skin biopsy, including severe thrombocytopenia or other conditions that make skin biopsy unsafe in the judgment of the investigator.\n* Active uncontrolled infection.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","OBSERVATIONAL","Chronic graft-versus-host disease (cGVHD) is a condition that can develop after a stem cell transplant. It occurs when donor immune cells attack the body's tissues. In many people, cGVHD affects the skin, causing inflammation, thickening, and scarring that can limit movement and reduce quality of life.\n\nAxatilimab is a medicine approved by the U.S. Food and Drug Administration (FDA) to treat adults with cGVHD after at least two previous treatments have not worked well enough. Although axatilimab can improve cGVHD, researchers do not fully understand how it changes immune cells in the skin.\n\nThe purpose of this study is to learn how axatilimab affects immune cells in the skin and blood of people with cGVHD. Researchers will study skin and blood samples collected before and after participants start axatilimab. The goal is to better understand how the medicine reduces inflammation and scarring and to identify biological changes that occur during treatment.\n\nThis is an observational research study. The study does not decide whether participants receive axatilimab, when treatment starts, or what dose they receive. All treatment decisions are made by the participant's treating physician as part of routine medical care.\n\nAbout 15 adults with cGVHD involving the skin will participate. Ten participants who are starting axatilimab as part of their usual care will have three study visits: before treatment begins, about 2 weeks after starting treatment, and about 12 weeks after starting treatment. At each visit, participants will provide a small skin biopsy and a blood sample. Five participants with cGVHD who are not receiving axatilimab will serve as a comparison group and will complete one study visit with one skin biopsy and one blood sample. Researchers will also review participants' medical records and collect information about their skin disease over time.\n\nInformation from this study may help researchers better understand how axatilimab works in people with cGVHD. The findings may also help improve future research and guide the development of treatments for cGVHD and other diseases that cause tissue scarring.",[24,25,26,27],"Chronic Graft vs. Host Disease","GVHD","cGVHD","Graft Versus Host Disease in Skin",[26,25,29],"axatiliamab","NOT_YET_RECRUITING","2026-08-09",{"date":33,"type":34},"2026-08-12","ACTUAL",{"date":36,"type":20},"2026-10",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"Northwestern University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":4,"leadSponsor":66,"locationsCount":42},"100064662","natural-history-study-of-clinical-and-biological-factors-determining-outcomes-in-chronic-graft-versus-host-disease-100064662","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","1 Year","120 Years",{"count":52,"type":20},650,"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],[56,57,58,59],"cGVHD-associated graft-versus-tumor effects (GVT)","Allo-HSCT controls","Leukapheresis","Natural History","RECRUITING","2026-08-06",{"date":63,"type":34},"2026-08-07",{"date":65,"type":34},"2004-10-26",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"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":79,"type":20},50,"INTERVENTIONAL",[82],"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).",[85,24,86],"Graft vs. Host Disease","Corticosteroid-refractory Chronic Graft vs. Host Disease",[88,89,90,91,92,93,94,95,96],"cGvHD","GvHD","SR-cGvHD","ruxolitinib","INC424","Chinese adult","Pediatric","Corticosteroid","refractory","2026-06-04",{"date":99,"type":34},"2026-06-08",{"date":101,"type":34},"2025-09-09",{"date":103,"type":20},"2031-05-23",{"name":105,"class":106},"Novartis Pharmaceuticals","INDUSTRY",22]