[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-graft-versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-graft-versus-host-disease":579},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,43,70,91,119,159,182,201,225,252,277,296,318,338,358,378,405,424,445,466,487,512,535,557],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100561101","phase-3-a-study-to-evaluate-axatilimab-and-corticosteroids-as-initial-treatment-for-chronic-graft-versus-host-disease-100561101",false,"NCT06585774","A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)","AXemplify-357","Inclusion Criteria:\n\n* ≥ 12 years of age at the time of informed consent.\n* New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.\n* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.\n* Adequate hematologic function with ANC ≥ 0.5 × 109\u002FL independent of growth factors for at least 7 days prior to study entry.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.\n* Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.\n* Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg\u002Fkg per day (or methylprednisolone equivalent) for cGVHD.\n* Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.\n* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.\n* Prior treatment with CSF-1R targeted therapies.\n* Active, uncontrolled bacterial, fungal, parasitic, or viral infection.\n* Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.\n* History of acute or chronic pancreatitis.\n* Active symptomatic myositis.\n* History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.\n* Severe renal impairment, that is, estimated CrCl \\\u003C 30 mL\u002Fmin measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.\n* Impaired liver function, defined as total bilirubin \\> 1.5 × ULN and\u002For ALT and AST \\> 3 × ULN in participants with no evidence of liver cGVHD.\n* Pregnant or breastfeeding.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","12 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).",[27],"Chronic Graft-versus-host-disease",[29],"cGVHD","RECRUITING","2026-06-29",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2025-01-21",{"date":38,"type":21},"2030-03-31",{"name":40,"class":41},"Incyte Corporation","INDUSTRY",123,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100634078","dental-cleaning-to-prevent-chronic-graft-versus-host-disease-100634078","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","18 Years",{"count":51,"type":21},45,[53],"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.",[56,57,58],"Chronic Graft Versus Host Disease","Acute Graft Versus Host Disease","Hematopoietic and Lymphatic System Neoplasm","2026-06-18",{"date":61,"type":34},"2026-06-22",{"date":63,"type":21},"2026-07-15",{"date":65,"type":21},"2029-04-30",{"name":67,"class":68},"Fred Hutchinson Cancer Center","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100567095","phase-2-axatilimab-in-combination-with-extracorporeal-photopheresis-ecp-in-chronic-graft-versus-host-disease-100567095","NCT06663722","Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease","A Phase II b Study of Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease","Inclusion Criteria:\n\n1. Recipient of allogeneic hematopoietic cell transplantation (HCT).\n2. Age greater or equal to 12.\n3. Chronic GVHD per 2014 National Institutes of Health Consensus Criteria (NCC) (Jagasia et al. 2015) or overlap syndrome requiring new therapy in patients with at least 2 prior lines of therapy, steroid refractoriness, or steroid dependence:\n\n   1. Prior systemic lines of therapy may include corticosteroids, calcineurin inhibitor (CNI) or sirolimus, or other systemic immunosuppressive agent such as ruxolitinib, belumosudil, or ibrutinib. GVHD prophylaxis does not count as a prior line of therapy.\n   2. Steroid refractory is defined as any of the following criteria:\n\n      * i. Manifestations progress despite the use of ≥ 1 mg\u002Fkg\u002Fday prednisone for at least 1 week\n      * ii. Manifestations persist without improvement despite treatment with ≥ 0.5 mg\u002Fkg\u002Fday or 1 mg\u002Fkg every other day for at least four weeks.\n      * iii. Recurrence after a CR, or\n      * iv. Progression after a PR.\n   3. Steroid dependence is defined as inability to control cGVHD symptoms while tapering prednisone below 0.25 mg\u002Fkg\u002Fday on at least two occasions separated by at least 8 weeks. There must be evidence of clinically active cGVHD.\n4. For patients receiving approved or commonly used agents, all GVHD systemic treatments should be discontinued except for corticosteroids and drugs being continued from GVHD prophylaxis at screening.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-3 as assessed at Screening.\n6. Platelet count \\> 50,000 platelets\u002FμL and absolute neutrophil count \\> 1,000 cells\u002FμL as measured at Screening.\n7. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), unless attributed to presumed cGVHD as measured at Screening.\n8. Stable dose of corticosteroids for at least 14 days prior to treatment.\n9. Sexually mature individuals must use contraception as described in Section 4.12. For individuals less than 18 years of age, sexual maturity will be determined as per treating pediatrician.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding.\n2. Active relapse of underlying malignancy.\n3. History or the presence of interstitial pneumonitis or drug-related pneumonitis.\n4. Active gastrointestinal (GI) bleeding.\n5. Inability to tolerate volume shifts associated with ECP (e.g., inadequate renal, hepatic, pulmonary and cardiac function (ejection fraction (EF) \\\u003C 40%) per Investigator discretion.\n6. History of myositis.\n7. History of splenectomy.\n8. History of pancreatitis.\n9. History of other malignancy (within 3 years of Screening) unless treated with curative intent and approved by Principal Investigator (PI).\n10. Significant, uncontrolled, or active comorbid conditions or are unable to adhere to the study requirements.\n11. Acquired Immune Deficiency Syndrome (AIDS) or active hepatitis B (Hep B) or active hepatitis C (Hep C) infection.\n12. Prior colony-stimulating factor-1 (CSF-1R) targeted therapies.\n13. Prior history of ECP treatment failure or intolerance.\n14. Intolerance to methoxsalen, heparin, or citrate products.\n15. Patients with aphakia due to risk of increased retinal damage or photosensitive disease (albinism, systemic lupus erythematosus, porphyria).\n16. Lack of stable IV access. Acceptable forms include central venous catheter, peripherally inserted central catheter (PICC), or peripheral IV line per institutional guidelines.\n17. Insurance denial of coverage for the ECP procedure.",{"count":78,"type":21},49,[80],"PHASE2","The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).",[56,29],{"date":61,"type":34},{"date":85,"type":34},"2025-05-05",{"date":87,"type":21},"2030-05-05",{"name":89,"class":68},"University of Miami",3,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100510155","phase-2-belumosudil-for-bronchiolitis-obliterans-preventiontherapy-bebop-100510155","NCT05922761","BElumosudil for Bronchiolitis Obliterans Prevention\u002FTherapy (BEBOP)","An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria Cohort A:\n\n* Diagnosis of BOS after HCT using pulmonary function testing, per the NIH diagnostic criteria17 OR the Atypical BOS criteria33 3.1.2.1 NIH Diagnostic Criteria for BOS. All of the following must be met:\n\n  * FEV1\u002FVC \\\u003C 0.7 or \\\u003C5th percentile of predicted (FEV1 = Forced Expiratory Volume in 1 second; VC = Vital Capacity (either FVC, Forced Vital Capacity, or SVC, Slow Vital Capacity, whichever is greater)\n  * FEV1 \\\u003C75% of predicted with ≥ 10% absolute decline over less than 2 years. FEV1 should not correct to \\>75% of predicted with albuterol, and the absolute decline for the corrected values should still remain ≥ 10% over 2 years.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage).\n  * One of the two supporting features of BOS:\n\n    * i - Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR\n    * ii - Evidence of air trapping by PFTs: RV (Residual Volume) \\> 120% of predicted or RV\u002FTLC elevated outside the 90% confidence interval (RV\u002FTotal Lung Capacity).\n* Atypical Criteria for BOS:\n\n  * FEV1 \\\u003C80% of predicted with ≥ 10% absolute decline over the last 2 years or since transplant. The remote comparator can be an evaluation of PFTs done within 2 years of the PFTs assessment being evaluated to determine eligibility or the PFT assessment done prior to transplant.\n  * VC \\\u003C 80% of predicted.\n  * FEV1\u002FVC \\> 0.7.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage) or active non-infectious lung disease (such as interstitial lung disease) that explain spirometric changes or chest CT findings.\n\nInclusion Criteria for Cohort B:\n\n-Diagnosis of BOS-0p\n\n* Decline in FEV1 of 10% - 19% of predicted compared with pretransplant testing OR\n* Decline in predicted FEF25-75% (Forced Expiratory Flow between 25% and 75% of vital capacity) \\> 25%\n\nInclusion Criteria for Cohorts A and B:\n\n* Age ≥18 years. Belumosudil is currently being tested in pediatric populations and the safety and efficacy in pediatric patients have not yet been established. A protocol amendment to include pediatric patients will be considered once safety in pediatric patients is established.\n* ECOG performance status ≤2 (Karnofsky ≥ 60%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * WBC ≥ 3,000\u002FμL\n  * Absolute neutrophil count ≥ 1,500\u002F μL\n  * Platelets ≥ 50,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* No evidence of relapsed malignancy at the time of enrollment. Formal re-staging is not required for trial entry.\n* All females of childbearing potential must have a negative serum or urine pregnancy test \\\u003C 7 days before study drug administration.\n* The ability to understand and willingness to sign a written consent document.\n\nExclusion Criteria for Cohorts A and B:\n\n* Participants who have received prior therapy specifically for BOS. Therapy for cGVHD in the absence of BOS is permissible.\n* Prior exposure to belumosudil.\n* Participants who are receiving any other investigational immunosuppressive agents for cGVHD.\n* Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persistent fever without signs or symptoms will not be interpreted as an active uncontrolled infection.\n* Known human immunodeficiency virus infection. Interactions between belumosudil and anti-retroviral agents have not been established.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.",{"count":51,"type":21},[80],"The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).\n\nThe name of the study drugs involved in this study are:\n\n* Belumosudil (an immunotherapy)\n* Fluticasone (an intranasal corticosteroid)\n* Azithromycin (an antibiotic)\n* Montelukast (a leukotriene receptor antagonist)\n* Prednisone (a corticosteroid)",[102,103,104,56],"Bronchiolitis Obliterans Syndrome","Bronchiolitis Obliterans","Lung Diseases",[102,103,106,107,108,56],"Lung Disease","Allogeneic hematopoietic stem cell transplant","HSCT","2026-06-08",{"date":111,"type":34},"2026-06-10",{"date":113,"type":34},"2024-05-31",{"date":115,"type":21},"2027-12-31",{"name":117,"class":68},"Dana-Farber Cancer Institute",6,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":138,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","CAN3001","Inclusion Criteria:\n\n* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib\n* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks\n* Agrees to protocol-defined use of effective contraception\n* Negative blood or urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Requires anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with strong cytochrome P450 (CYP)3A4\u002F5 inhibitors, unless previously approved by sponsor\n* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study",{"count":128,"type":21},700,[24],"The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[132,133,134,135,136,137,56],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Follicular Lymphoma","Diffuse Large B-cell Lymphoma","Waldenstrom Macroglobulinemia",[139,140,141,142,143,144,145,146,147,148],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Mantle cell lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060","2026-06-04",{"date":151,"type":34},"2026-06-05",{"date":153,"type":34},"2013-09-09",{"date":155,"type":21},"2029-12-31",{"name":157,"class":41},"Janssen Research & Development, LLC",175,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":167,"maxAge":49,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100601863","phase-2-a-study-of-belumosudil-in-children-with-chronic-graft-versus-host-disease-schoolrock-100601863","NCT07116031","A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)","An Open-label, Phase 1\u002F2, Multicenter Study of Belumosudil in Children Aged 1 to \u003C18 Years Requiring Systemic Treatment for Active Moderate-to-severe Chronic Graft Versus Host Disease (cGVHD)","schoolROCK","Inclusion Criteria:\n\n* Participant must be 1 to \\\u003C18 years of age, at the time the consent\u002Fassent is signed. For Phase 1: participant must be 1 to \\\u003C12 years of age, at the time the consent\u002Fassent is signed. For Phase 2: participant must be 1 to \\\u003C18 years of age, at the time the consent\u002Fassent is signed.\n* Participant has undergone an allogeneic HCT\n* Has active moderate to severe cGVHD, defined using the NIH Consensus diagnosis and staging criteria for which systemic therapy is required\n* cGVHD is refractory to or has recurred after at least 2 prior lines of systemic treatment\n* Has received at least two lines of prior systemic therapy for cGVHD, but no more than 5 lines.\n* If participant receives corticosteroid therapy for cGVHD, the dose must be stable for at least 2 weeks prior to the first dose of the IMP\n* Has a Lansky-Play (if aged \\\u003C16 years) or Karnofsky (if aged ≥16 years) performance scale of ≥60\n* Body weight of 8 kg and above\n* Contraceptive use by sexually active male and female should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent\n* Life expectancy of \\>6 months\n* Participants can take the IMP orally or via a nasogastric tube\n\nExclusion Criteria:\n\n* Progressive underlying disease or post-transplant lymphoproliferative disease within 4 weeks prior to the first dose of the IMP.\n* Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years prior to the first dose of the IMP\n* History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, active, uncontrolled infections, or poorly controlled psychiatric disease)\n* Has a forced expiratory volume (in the first second; FEV1) ≤39% or has lung score of 3\n* Female participants who are pregnant or breastfeeding\n* Participants who meet any of the following criteria regarding systemic GVHD treatments:\n* Participants who newly initiated any systemic GVHD treatment within 14 days prior to the first dose of belumosudil.\n* Participants receiving systemic GVHD treatments ibrutinib, ruxolitinib, mycophenolate (MMF), methotrexate, rituximab, axatilimab, or imatinib who are unable to meet the following requirements:\n* No dose increases from 14 days prior to belumosudil initiation and continuing for the first 14 days of belumosudil treatment (dose reductions and discontinuations are permitted during this period)\n* Ability to discontinue these therapies within 14 days after initiating belumosudil (allowing for a maximum overlap period of up to 14 days with belumosudil treatment)\n* Participants receiving other systemic GVHD treatments (apart from corticosteroids and calcineurin inhibitors) including investigational treatments who have not completed a washout period of at least 28 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil. No washout period is required for extracorporeal photopheresis (ECP) or sirolimus therapy, but these must be discontinued before study treatment initiation.\n\nNote: Corticosteroids and calcineurin inhibitors may continue throughout the study.\n\n* The use of herbal and recreational drugs within 7 days before the start of study intervention\n* Participant has had previous exposure to belumosudil\n* Administration of live or live-attenuated vaccines is prohibited within 28 days or 5 elimination half-lives of the respective vaccine, whichever is longer, prior to IMP administration and until study intervention discontinuation\n* Treatment with any non-GVHD investigational agent, or any investigational device or procedure, within 28 days (or 5 half-lives, whichever is longer) of enrollment, prior to the first dose of the IMP\n* For Phase 1 only: Administration with strong CYP3A4 inducers is not allowed within 14 days or 5 half-lives (whichever is longer) of the first dose of IMP until the study intervention discontinuation.\n* For Phase 1 only: PPIs are not allowed within 1 day or 5 half-lives (whichever is longer) of the first dose of IMP and Day 15 of Cycle 1. They can be restarted on Cycle 1 Day 16.\n* Absolute neutrophil count \\\u003C1.0 × 109\u002FL. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed within 7 days prior to the ANC test to reach this level during screening\n* Platelet count \\\u003C25 × 109\u002FL. Platelet transfusions are not allowed within 72 hours before hematology screening test. Participants with platelet transfusion refractoriness will be excluded. (Participants who have suboptimal responses to at least 2 transfusions will be considered as platelet transfusion refractory)\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN) (\\> 5x ULN if abnormalities are due to cGVHD)\n* Total bilirubin \\>1.5 × ULN (\\>3 x ULN if Gilbert's syndrome or if abnormalities are due to cGVHD)\n* Glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 using the revised Bedside Schwartz calculator\n* Participants with an active viral disease including hepatitis B virus (HBV) and hepatitis C virus (HCV)\n* Active uncontrolled Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection\n* Known history of human immunodeficiency virus (HIV)\n* Not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","1 Year",{"count":169,"type":21},37,[80],"This is an open-label, single group, Phase 1\u002F2, 1-arm study for treatment of children aged 1 to \\\u003C18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD.\n\nThe purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to \\\u003C12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to \\\u003C18 years.\n\nStudy details include:\n\nThe end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first.\n\nMinimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study\n\nIndividual participant duration on study will consist of:\n\nUp to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse\u002Frecurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.\n\n30 days of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.",[56],"2026-06-03",{"date":151,"type":34},{"date":176,"type":34},"2025-12-02",{"date":178,"type":21},"2031-02-28",{"name":180,"class":41},"Sanofi",33,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100515831","phase-2-belumosudil-for-the-pre-emptive-treatment-of-patients-with-chronic-graft-versus-host-disease-100515831","NCT05996627","Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease","Randomized Phase II Study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease","Inclusion Criteria:\n\n* At least one diagnostic or distinctive cGVHD manifestation(s), with a clinical diagnosis of cGVHD,but patients do not need to meet National Institute of Health (NIH) criteria for cGVHD\n* If eye involvement only, cGVHD must be confirmed on exam by an ophthalmologist or optometrist\n* No new immune suppressive therapy added within preceding 2 weeks prior to study enrollment for any indication\n\n  * Continuation of agents previously given as either GVHD prophylaxis or acute\u002Flate acute GVHD therapy are permitted. Modification of dose of these agents for targeting of therapeutic drug levels is permitted, as are decreases in existing prednisone or prednisone equivalent dose based on routine clinical tapering practices. Increases in prednisone or prednisone equivalents are not allowed in the 2 weeks prior to enrollment\n* Age 18 and older\n* Karnofsky performance score \\>= 70\n* Able to take oral medications\n* Signed informed consent\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN)\n* Total bilirubin =\\\u003C 1.5 x ULN, unless due to Gilbert's disease\n* Glomerular filtration rate (estimated glomerular filtration rate \\[eGFR\\]) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\n* Female subjects of childbearing potential have a negative serum or urine pregnancy test at screening. Females of childbearing potential are defined as sexually mature females without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression\n* Sexually active females of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:\n\n  * Intrauterine device (IUD) plus one barrier method\n  * Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method\n  * 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm)\n  * Surgical sterilization (tubal ligation)\n  * A vasectomized partner\n* For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug\n* No evidence of active malignancy\n\nExclusion Criteria:\n\n* Any systemic immune suppressive treatment for cGVHD (topical or local therapies are allowed)\n* Plan to start systemic immune suppressive therapy for cGVHD or increase steroid dose within 14 days after planned start of study medication\n* 0.25 mg\u002Fkg\u002Fday or higher prednisone or prednisone equivalent dose at time of screening\n* History of non-compliance that in the investigator's opinion would interfere with study participation\n* Uncontrolled psychiatric illness\n* Female subject who is pregnant or breast feeding\n* Previous therapy with belumosudil\n* Known allergy\u002Fsensitivity to belumosudil or any other ROCK2 inhibitor\n* Treatment with another investigational agent within 28 days (or 5 half-lives, whichever is greater) of enrollment",{"count":190,"type":21},82,[80],"This phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease. Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.",[56],{"date":149,"type":34},{"date":196,"type":34},"2023-12-06",{"date":198,"type":21},"2028-11-30",{"name":67,"class":68},5,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100602482","phase-2-a-study-to-evaluate-axatilimab-versus-best-available-therapy-in-pediatric-participants-with-chronic-graft-versus-host-disease-after-at-least-2-prior-lines-of-systemic-therapy-agave-256-100602482","NCT07124078","A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)","A Phase 2, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)","Inclusion Criteria:\n\n* Aged ≥ 2 to \\\u003C 18 years at the time of signing the informed consent.\n* Active, moderate to severe cGVHD, requiring systemic immune suppression.\n* Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.\n* Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed.\n* Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, imatinib, methotrexate, or ibrutinib.\n* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.\n\nExclusion Criteria:\n\n* Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.\n* Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.\n* Severe renal impairment, that is, GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 as estimated using modified Schwartz formula, or end-stage renal disease on dialysis.\n* Impaired liver function, defined as total bilirubin \\> 1.5 × ULN and\u002For ALT and AST \\> 3 × ULN in participants with no evidence of liver cGVHD.\n* History of acute or chronic pancreatitis.\n* Active, symptomatic myositis.\n* Female adolescent participants who are pregnant or breastfeeding.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","2 Years","17 Years",{"count":211,"type":21},60,[80],"This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.",[27],[29],"2026-06-01",{"date":218,"type":34},"2026-06-02",{"date":220,"type":34},"2026-05-20",{"date":222,"type":21},"2029-07-31",{"name":40,"class":41},41,{"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":208,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100417045","phase-2-a-study-of-axatilimab-at-3-different-doses-in-participants-with-chronic-graft-versus-host-disease-cgvhd-100417045",true,"NCT04710576","A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)","AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy","AGAVE-201","Inclusion Criteria:\n\n1. Participants must be 2 years of age or older, at the time of signing the informed consent.\n2. Participants who are allogeneic hematopoietic stem cell transplantation (HSCT) recipients with active cGVHD requiring systemic immune suppression. Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.\n3. Participants with refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy.\n\n   * Refractory disease defined as meeting any of the following criteria:\n\n     * The development of 1 or more new sites of disease while being treated for cGVHD.\n     * Progression of existing sites of disease despite at least 1 month of standard or investigation therapy for cGVHD.\n     * Participants who have not achieved a response within 3 months on their prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.\n   * Recurrent cGVHD is active, symptomatic disease (after an initial response to prior therapy) as defined, based on the NIH 2014 consensus criteria, by organ-specific or global assessment or for which the physician believes that a new line of systemic therapy is required.\n4. Participants may have persistent, active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.\n5. Karnofsky Performance Scale of ≥60 (if aged 16 years or older); Lansky Performance Score of ≥60 (if aged \\\u003C16 years)\n6. Adequate organ and bone marrow functions evaluated during the 14 days prior to randomization.\n7. Creatinine clearance (CrCl) ≥30 milliliter\u002Fminute based on the Cockcroft-Gault formula in adult participants and Schwartz formula in pediatric participants.\n8. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n9. Concomitant use a of systemic corticosteroid is allowed but not required. Topical and inhaled corticosteroid agents are allowed. If a participant is taking corticosteroids at study randomization, they must be on a stable dose of corticosteroids for at least 2 weeks prior to Cycle 1 Day 1.\n10. Concomitant use of CNI or mammalian target of repamycin (mTOR) inhibitors (sirolimus or everolimus) is allowed but not required.\n11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol. A parent\u002Fguardian should provide consent for pediatric participants unable to provide consent themselves; in addition, where applicable pediatric participants should sign their own assent form.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has acute GVHD without manifestations of cGVHD.\n2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.\n3. History of acute or chronic pancreatitis.\n4. History of myositis.\n5. History or other evidence of severe illness, uncontrolled infection or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study.\n6. Participants with acquired immune deficiency syndrome (AIDS).\n7. Hepatitis B (defined as hepatitis B virus \\[HBV\\] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid \\[DNA\\], or HBV positive core antibody alone with positive HBV DNA. Hepatitis C (defined as positive hepatitis C \\[HCV\\] antibody with positive HCV ribonucleic acid \\[RNA\\]).\n8. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of randomization, unless previously treated with curative intent and approved by Sponsor's Medical Monitor (for example, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).\n9. Female participant who is pregnant or breastfeeding.\n10. Previous exposure to CSF1-R targeted therapies.\n11. Taking agents for treatment of cGVHD other than corticosteroids or either a CNI or mTOR inhibitor is prohibited.\n12. For approved or commonly used agents, other than corticosteroids, CNI and mTOR inhibitor, a washout of 2 weeks or 5 half-lives, whichever is shorter, is required at study enrollment.\n13. Receiving another investigational treatment within 28 days of randomization.\n14. Participants should not be participating in any other interventional study. Pediatric participants are encouraged to also participate in the ongoing developmental studies of the Pediatric cGVHD Symptom Scale (PCSS).",{"count":235,"type":21},296,[80],"This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.",[27],[29,232,240,241,242],"GVHD","graft versus host disease","graft-versus-host-disease",{"date":244,"type":34},"2026-06-16",{"date":246,"type":34},"2021-03-04",{"date":248,"type":21},"2027-09",{"name":250,"class":41},"Syndax Pharmaceuticals",121,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":259,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":69},"100637881","phase-2-a-prospective-study-of-madecassoside-tablets-in-sclerotic-chronic-graft-versus-host-disease-after-allo-hsct-100637881","NCT07606703","A Prospective Study of Madecassoside Tablets in Sclerotic Chronic Graft-versus-Host Disease After Allo-HSCT","A Prospective, Multicenter, Single-Arm Phase 2 Study of Madecassoside Tablets Combined With Standard Therapy for Sclerotic Chronic Graft-versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign written informed consent;\n2. Age 14 to 65 years;\n3. Diagnosis of sclerotic chronic graft-versus-host disease (scl-cGVHD) according to the 2014 NIH consensus criteria, including superficial or deep skin sclerosis, fasciitis, or restricted joint mobility;\n4. Prior treatment history meeting at least one of the following:\n\n   * Received systemic corticosteroid therapy for ≥12 months and at least 1 additional systemic therapy; OR\n   * Received corticosteroid therapy and at least 2 additional systemic therapies;\n5. Karnofsky Performance Status (KPS) score ≥60;\n6. Absolute neutrophil count \\>1,000\u002FμL;\n7. Platelet count ≥50,000\u002FμL.\n\nExclusion Criteria:\n\n* 1\\. Total bilirubin \\>1.5 times the upper limit of normal; 2. Creatinine clearance \\\u003C30 mL\u002Fmin; 3. Uncontrolled infection; 4. Uncontrolled cardiovascular or pulmonary disease; 5. Any clinical condition that, in the investigator's judgment, makes the participant unsuitable for study participation.","14 Years","65 Years",{"count":262,"type":21},30,[80],"Sclerotic chronic graft-versus-host disease (scl-cGVHD) is a severe subtype of chronic GVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT), characterized by skin sclerosis, fascial involvement, and restricted joint mobility, leading to substantial functional impairment and reduced quality of life. Current standard therapies, including corticosteroids and other immunosuppressive agents, have limited efficacy in patients with refractory or steroid-dependent disease.\n\nMadecassoside tablets, a standardized extract of Centella asiatica, have demonstrated anti-inflammatory and anti-fibrotic properties in previous studies and may provide therapeutic benefit in fibrotic diseases.\n\nThis study is a prospective, multicenter, single-arm phase 2 clinical trial designed to evaluate the efficacy and safety of madecassoside tablets combined with standard therapy in patients with scl-cGVHD after allo-HSCT. Eligible participants will receive oral madecassoside tablets (0.2 g three times daily) in addition to standard treatment for 6 months. Clinical assessments will be performed at baseline and at weeks 4, 8, 12, and 24.\n\nThe primary endpoint is the improvement rate of skin and\u002For joint\u002Ffascia NIH cGVHD scores at 6 months according to the 2014 NIH consensus criteria. Secondary endpoints include overall cGVHD response rate, failure-free survival, non-relapse mortality, corticosteroid dose reduction, patient-reported outcomes, and safety assessments. Peripheral blood samples will also be collected to explore changes in inflammatory cytokines and lymphocyte subsets during treatment.",[266,267],"Chronic Graft-Versus-Host Disease","Graft vs Host Disease","2026-05-18",{"date":270,"type":34},"2026-05-26",{"date":272,"type":34},"2025-09-01",{"date":274,"type":21},"2029-09-01",{"name":276,"class":68},"WeiShi",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100395621","predicting-the-quality-of-response-to-specific-treatments-in-patients-with-cgvhd-pqrst-study-100395621","NCT04431479","Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study","Predicting the Quality of Response to Specific Treatments (PQRST)","Inclusion Criteria:\n\n* Adults age 18 or older\n* Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis\n* No evidence of persistent or progressive malignancy at the time of enrollment\n* Agrees to be evaluated at the transplant center before a new line of treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after index treatment is started or if an additional new therapy is started before 6 months\n* Signed, informed consent\n\nExclusion Criteria:\n\n* Inability to comply with study procedures\n* Uncontrolled psychiatric disorder\n* Anticipated survival \\\u003C 6 months",{"count":285,"type":21},300,"OBSERVATIONAL","This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start a new therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.",[56],{"date":220,"type":34},{"date":291,"type":34},"2020-06-29",{"date":293,"type":21},"2027-07-01",{"name":67,"class":68},10,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":309,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100603396","phase-4-a-study-to-investigate-safety-of-belumosudil-in-participants-aged-12-years-and-above-with-chronic-graft-versus-host-disease-cgvhd-100603396","NCT07135973","A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)","A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)","Inclusion Criteria:\n\n* Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent\n* Participants who had an allogeneic hematopoietic cell transplantation (HCT)\n* Previously received at least 2 prior lines of systemic therapy for cGVHD\n* Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening\n* Had persistent cGVHD manifestations and systemic therapy was indicated\n* Karnofsky (if aged ≥ 16 years)\u002FLansky (if aged \\\u003C16 years) Performance Score of ≥ 60\n* Capable of giving signed informed consent as described in the protocol\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Absolute neutrophil count ≤1.5 X 109\u002FL\n* Platelet count ≤ 50 X 109\u002FL\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (\\>5 × ULN if due to cGVHD)\n* Total bilirubin ≥ 1.5 X ULN\n* Glomerular filtration rate (GFR) ≤ 30 mL\u002Fmin\u002F1.73m3\n* Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening\n* FEV1 ≤39% or has lung score of 3\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":304,"type":21},26,[306],"PHASE4","This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.\n\nStudy details include:\n\n* The study duration will be up to 12 months per participant.\n* The treatment duration will be up to 24 weeks.\n* The number of visits will be 7.",[56],"NOT_YET_RECRUITING","2026-05-11",{"date":312,"type":34},"2026-05-12",{"date":314,"type":21},"2026-08-10",{"date":316,"type":21},"2028-03-17",{"name":180,"class":41},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":336,"locationsCount":69},"100519645","phase-2-belumosudil-and-rituximab-for-primary-treatment-of-chronic-graft-versus-host-disease-100519645","NCT06046248","Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease","Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease","Inclusion Criteria:\n\n* First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)\n* Previously untreated, defined by having received \\\u003C10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD\n* KPS \\>\u002F= 70%\n* Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC \\>750 cells\u002Fmm3; Platelets \\>30,000 cells\u002Fmm#\n\nExclusion Criteria:\n\n* Late persistent or recurrent aGVHD\n* Active uncontrolled infection\n* History of HIV infection\n* Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.\n* Calculated CrCl \\\u003C30mL\u002Fmin\n* AST and\u002For ALT \\>5x ULN or direct bilirubin \\>3x ULN\n* Cardiac ejection fraction \\\u003C40% or history of uncontrolled cardiac arrhythmias\n* Has received more than one allogeneic transplant prior to the occurrence of cGVHD",{"count":326,"type":21},25,[80],"This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.",[56],"2026-04-15",{"date":332,"type":34},"2026-04-20",{"date":334,"type":34},"2024-01-29",{"date":115,"type":21},{"name":337,"class":68},"Northside Hospital, Inc.",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":309,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":4},"100634402","establishment-of-biomarker-panel-for-forecasting-chronic-graft-versus-host-disease-cgvhd-after-allo-hsct-100634402","NCT07539220","Establishment of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT","Establishment Of Biomarker Panel For Forecasting Chronic Graft-Versus-Host Disease (cGVHD) After Allo-HSCT","Inclusion Criteria:\n\n1. Patients with hematological disease survived more than 3 months after allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. Over 18 years old.\n3. Written informed consent or a waiver by the Ethics Committee (EC) at the site.\n4. HIV negative, HBV, HCV negative.\n\nExclusion Criteria:\n\n1. Previous autologous or allogeneic stem cell transplantation before enrollment.\n2. Suffering from mental illness or other conditions and not being able to cooperate with research treatment and monitoring requirements.\n3. Patients with other special conditions who were assessed as unqualified by the researchers.",{"count":346,"type":21},1500,[53],"This study is a single-center observational clinical study. Participants were enrolled as two cohorts of patients including discovery cohort and validation cohort. A total of consecutive 1000 patients receiving allo-HSCT in our center from 2021.01 to 2023.06 were retrospectively included as discovery cohort. A total of consecutive 500 recipients from 2023.06 to 2024.06 were retrospectively enrolled as validation cohort.\n\nHeparinized blood samples were collected prospectively at day +90 after HSCT and the onset of manifestations in patients with cGVHD or at matched time points in controls. Patients in the validation cohort also had samples drawn at approximately day +90. We used multiplex mass spectrometry with pooled plasma for biomarker discovery in comparing proteomic profiles between patients with and without chronic GVHD.",[266],"2026-04-13",{"date":332,"type":34},{"date":353,"type":21},"2026-04",{"date":355,"type":21},"2028-12",{"name":357,"class":68},"Institute of Hematology & Blood Diseases Hospital, China",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":90},"100593851","phase-2-axatilimab-for-sclerotic-chronic-graft-versus-host-disease-100593851","NCT07011810","Axatilimab for Sclerotic Chronic Graft-versus-Host Disease","Axatilimab for Sclerotic Chronic Graft-Versus-Host Disease","Inclusion Criteria:\n\n* Adults aged 18 and older\n* Ability to understand and willingness to sign a written informed consent document\n* Allogeneic stem cell transplant, with active cGVHD requiring systemic treatment. Active cGVHD is defined as the presence of signs and symptoms of cGVHD diagnosed per the 2014 National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical trials in cGVHD\n* Sclerotic skin score 2-3 or PROM \\\u003C 24 due to cGVHD\n* Initial diagnosis of sclerosis within the past 24 weeks (168 days)\n* No new non-corticosteroid systemic immunosuppressive agent within 28 days prior to screening, unless there is a plan to stop them no later than 21 days after the first dose of axatilimab. Receipt of systemic corticosteroids ≤ 1 mg\u002Fkg prednisone or prednisone equivalent daily is allowed at the time of enrollment and may be continued after axatilimab initiation\n* If patient has been previously treated with systemic immunosuppression for sclerosis, one of the following two conditions must be true: (a) the systemic immunosuppressive treatment(s) were given for at least 60 days and the sclerotic cGVHD either did not respond or progressed; (b) the systemic immunosuppressive treatment(s) were given for less than 60 days due to lack of sclerotic cGVHD response, sclerotic cGVHD progression, toxicity or logistic reasons and have or will be stopped no later than 21 days after the first dose of axatilimab\n* Karnofsky performance status ≥ 60%\n* Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL (evaluated during the 28-day screening period)\n* Platelet count ≥ 50 x 10\\^9\u002FL (evaluated during the 28-day screening period) (without transfusion within 2 weeks of study entry)\n* If no suspected or proven liver cGVHD, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) (evaluated during the 28-day screening period) unless due to Gilbert's disease\n* If no suspected or proven liver cGVHD, total bilirubin ≤ 1.5 x ULN (evaluated during the 28-day screening period) unless due to Gilbert's disease\n* For patients with suspected or documented liver cGVHD, ALT and AST ≤ 5 x ULN (evaluated during the 28-day screening period) unless due to Gilbert's disease\n* For patients with suspected or documented liver cGVHD, total bilirubin ≤ 1.5 x ULN (evaluated during the 28-day screening period) unless due to Gilbert's disease\n* Estimated creatinine clearance ≥ 30 mL\u002Fmin based on the institutional formula\n* Male and female participants of reproductive potential must be willing to employ highly effective and acceptable forms of contraception from screening through 90 days after the last dose of study treatment.\n\n  * Adolescent and adult male patients capable of fathering a child who are non-sterilized and who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use two methods of birth control from the time of screening throughout the total duration of the study intervention treatment period and 90 days after the last dose of study intervention. Male patients should refrain from sperm donation throughout this period\n  * Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening throughout the total duration of the study intervention treatment period and 90 days after the last dose of study intervention. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female patients should also refrain from breastfeeding throughout this period\n  * Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to treatment initiation. Females of childbearing potential are defined as sexually mature females without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression\n\nExclusion Criteria:\n\n* Hospitalization for evaluation or management of an infection within 28 days prior to screening\n* History or other evidence of significant organ dysfunction that would make the patient, in the opinion of the investigator, unsuitable for the study\n* On more than 1 mg\u002Fkg\u002Fday prednisone or prednisone equivalent\n* History of non-compliance\n* History or other evidence of uncontrolled psychiatric illness that that would limit compliance with study requirements\n* Receipt of an investigational agent within 28 days prior to screening\n* Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening\n* Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of study enrollment, unless previously treated with curative intent (e.g. complete resected basal or squamous cell carcinoma of the skin)\n* Active hepatitis B (defined as hepatitis B virus \\[HBV\\] surface antigen positive and HBV core antibody positive, with positive HBV deoxyribonucleic acid \\[DNA\\], or HBV positive core antibody alone with positive HBV DNA) or hepatitis C (defined as positive hepatitis C \\[HCV\\] antibody with positive HCV ribonucleic acid \\[RNA\\])\n* Suspected active or latent tuberculosis (as confirmed by a positive QuantiFERON® test or other tuberculosis blood test)\n* History of acute or chronic pancreatitis\n* History of myositis\n* Pregnant or breastfeeding\n* Previous exposure to colony stimulating factor 1 receptor (CSF-1R) therapies",{"count":366,"type":21},50,[80],"This phase II trial tests how well axatilimab works in treating patients with thickening or hardening (sclerosis) of the skin related to chronic graft-versus-host disease after a donor stem cell transplant. Chronic graft-versus-host disease (cGVHD) remains a major complication of donor stem cell transplants. Sclerosis, while not associated with a higher risk of death, can lead to serious disabilities. Usual treatments for cGVHD can be associated with significant side effects and unsatisfactory outcomes. A monoclonal antibody, like axatilimab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Axatilimab blocks a receptor and depletes cells that may be involved in the development of inflammation and fibrosis in cGVHD. Giving axatilimab may improve or prevent worsening of sclerosis related to cGVHD in patients after a donor stem cell transplant.",[56],"2026-03-25",{"date":372,"type":34},"2026-03-27",{"date":374,"type":34},"2025-08-06",{"date":376,"type":21},"2030-02-10",{"name":67,"class":68},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":393,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},"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":387,"type":21},36,[53],"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",[391,392,27],"Graft Vs Host Disease","Acute-graft-versus-host Disease",[391,392,27,394,395],"Corticosteroids","Allogeneic stem cell transplant","2026-03-09",{"date":398,"type":34},"2026-03-11",{"date":400,"type":34},"2022-04-14",{"date":402,"type":21},"2027-09-09",{"name":117,"class":68},2,{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":69},"100602777","evaluation-of-belumosudil-whole-tablets-vs-crushed-tablets-pharmacokinetics-in-patients-suffering-from-chronic-gvhd-100602777","NCT07127926","Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD","Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease","Inclusion Criteria:\n\n* Male and female subjects ≥ 18 years of age with allogeneic HSCT\n\nExclusion Criteria:\n\n* Receiving an investigational GVHD treatment within 28 days of study entry; (2) active acute GVHD; and (3) taking any medication known to be CYP3A4 inducers.\n* Pregnancy is an exclusion criterion for stem cell transplant. Pregnant women are not included in this study. Non-viable neonates will not be included in this study. Patients with cognitive impairments will not be included in this study. Patients aged less than 18 years old will not be included.",{"count":413,"type":21},8,"The primary objective of the study is to evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).",[56],"2026-02-16",{"date":418,"type":34},"2026-02-18",{"date":420,"type":34},"2026-02-09",{"date":115,"type":21},{"name":423,"class":68},"M.D. Anderson Cancer Center",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":444},"100580907","phase-1-a-ph1b2-study-of-axatilimab-monotherapy-in-chinese-participants-with-recurrent-or-refractory-cgvhd-100580907","NCT06843408","A Ph1b\u002F2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD","A Phase 1b\u002F2, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease After Systemic Therapy","Inclusion Criteria:\n\n* At least 12 years of age at the time of signing the ICF.\n* Ability to comprehend and willingness to sign a written ICF for the study.\n\n  • For participants 12 to 17 years old: A parent\u002Fguardian must provide consent for pediatric participants; when applicable, pediatric participants should also sign an assent form.\n* Chinese participants who are allo-HSCT recipients with active, refractory, or recurrent cGVHD requiring systemic immune suppression despite prior systemic therapy, including corticosteroids and at least 1 other appropriate treatment for refractory or recurrent cGVHD.\n\n  * Active cGVHD is defined as the presence of signs and symptoms of cGVHD per the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (Jagasia et al 2015).\n  * Refractory disease is defined as meeting any of the following criteria:\n\n    * The development of 1 or more new sites of disease while being treated for cGVHD.\n    * Progression of existing sites of disease despite at least 1 month of standard or investigational therapy for cGVHD.\n    * Participants who did not achieve a response within 3 months on prior therapy for cGVHD and for whom the treating physician believes a new systemic therapy is required.\n  * Recurrent cGVHD is defined as active, symptomatic disease (after an initial response to prior therapy) based on the NIH 2014 consensus criteria (Lee et al 2015) by organ-specific or global assessment or for which the physician believes a new line of systemic therapy is required.\n* Participants may have persistent, active aGVHD and cGVHD manifestations (overlap syndrome), as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.\n* Karnofsky performance score of ≥ 60 (if aged 16 years or older); Lansky performance score of ≥ 60 (if aged younger than 16 years).\n* Adequate organ and bone marrow functions evaluated during the 14 days prior to the start of study treatment as follows:\n\n  * Absolute neutrophil count ≥ 1.0 × 109\u002FL (without growth factors within 1 week of study entry).\n  * Platelet count ≥ 50 × 109\u002FL (without growth factor or transfusion within 2 weeks of study entry).\n  * ALT and AST ≤ 2.5 × ULN and total bilirubin ≤ 1.5 × ULN. Note: For participants with suspected or documented liver cGVHD: ALT and AST ≤ 5 × ULN and total bilirubin ≤ 1.5 × ULN.\n* Creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73 m2 based on the Cockcroft-Gault formula in adult participants and the Schwartz formula in pediatric participants.\n* Concomitant use of a systemic corticosteroid is allowed but not required. Topical and inhaled corticosteroid agents are allowed. If a participant is taking a corticosteroid, it must be a stable dose for at least 2 weeks prior to the start of study treatment.\n* Concomitant use of CNIs or mTOR inhibitors is allowed but not required (the inhibitor may have been started either for prophylaxis or for treatment of cGVHD; the reason for initiating treatment must be recorded in the database). If a participant is taking a CNI or an mTOR inhibitor, the following criteria must be met:\n\n  * Must be a stable dose for at least 2 weeks prior to the start of study treatment.\n  * The dose must be within the therapeutic range.\n* Willingness to avoid pregnancy or fathering children based on the criteria below.\n\n  * Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last dose of study treatment and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n  * Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last dose of study treatment and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n  * Female participants not considered to be of childbearing potential as defined in the protocol are eligible.\n\nExclusion Criteria:\n\n* Has aGVHD without manifestations of cGVHD.\n* Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.\n* History of acute or chronic pancreatitis.\n* Active symptomatic myositis.\n* History or other evidence of severe illness, uncontrolled infection, allergy to excipients (see formulation details in the IB), or any other conditions that would make the participant, in the opinion of the investigator, unsuitable for the study.\n* Positive HIV status.\n* History of latent or active TB, including either one of following:\n\n  * Signs or symptoms suggestive of active TB upon medical history and\u002For physical examination.\n  * Recent close contact with a person with active TB.\n* Positive QuantiFERON and\u002For T-spot TB test at screening.\n* Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (ie, positive HBsAg). Participants with negative HBsAg and positive total HBcAb and\u002For HBsAb should be excluded if quantitative HBV DNA test result is ≥ 20 IU\u002FmL at the time of screening. Participants who are positive for HCV antibody are eligible only if PCR is negative for HCV RNA.\n* Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years before Cycle 1 Day 1 unless previously treated with curative intent (eg, completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection) and approved by the sponsor's medical monitor.\n* Pregnant or breastfeeding.\n* Previous exposure to CSF-1R targeted therapies.\n* Use of any agent other than corticosteroids, CNIs, or mTOR inhibitors for the treatment of cGVHD within 2 weeks or 5 half-lives, whichever is shorter, prior to the start of study treatment.\n* Has received an investigational treatment within 28 days prior to the start of study treatment.\n* Currently participating in any other interventional study.",{"count":262,"type":21},[433,80],"PHASE1","This study will be conducted to evaluate the safety, efficacy, and pharmacokinetics of axatilimab monotherapy in Chinese participants with recurrent or refractory active chronic graft-versus-host disease after systemic therapy.",[27],[29],"2026-01-30",{"date":439,"type":34},"2026-02-03",{"date":441,"type":34},"2025-06-25",{"date":115,"type":21},{"name":40,"class":41},9,{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":69},"100533998","phase-1-ruxolitinib-plus-fostamatinib-for-steroid-refractory-cgvhd-100533998","NCT06233110","Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD","Phase I Trial of Ruxolitinib Plus Fostamatinib for the Treatment of Steroid Refractory Chronic Graft Versus Host Disease","Inclusion Criteria\n\n1. Patient is able and willing to provide written informed consent prior to any study related screening procedures are performed.\n2. Age ≥ 18 years old at the time of informed consent\n3. Have undergone allogeneic hematopoietic cell transplantation (HCT) from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood, or cord blood stem cells.\n4. Adequate bone marrow function defined as:\n\n   4.1 Absolute neutrophil count (ANC) ≥ 750 \u002Fmm3 4.2 Platelet count ≥ 40,000 \u002Fmm3 4.3 Hemoglobin ≥ 8.0 g\u002FdL without transfusion support Note: Use of growth factor supplementation (myeloid, erythroid or megakaryocytic) is permitted to meet eligibility criteria.\n5. Patients with clinically diagnosed cGvHD staging of mild to severe according to NIH Consensus Criteria4 prior to Cycle 1 Day 1 and with confirmed steroid refractoriness or steroid dependence irrespective of the concomitant use of a calcineurin inhibitor, as follows:\n\n   5.1 Disease progression after administration of a minimum dose of 1.0 mg\u002Fkg\u002Fday or equivalent for at least 1 week at any time following diagnosis of cGvHD OR 5.2 Disease persistence despite continued treatment with prednisone \\> 0.5mg\u002Fkg\u002Fd or equivalent for at least 4 weeks OR 5.3 Increase to prednisone \\> 0.25 mg\u002Fkg\u002Fd after 1 unsuccessful attempt to taper the dose.\n\n   5.4 Recurrence of chronic GVHD after attaining a complete response 5.5 Progression of chronic GVHD after attaining a partial response\n6. Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n\nExclusion Criteria\n\n1. Prior or ongoing treatment with ruxolitinib for treatment of cGvHD for longer than 3 weeks prior to anticipated C1D1.\n2. Prior treatment with fostamatinib or another SYK inhibitor for the treatment of acute or chronic GVHD. Prior use of fostamatinib for conditions other than GVHD is permitted.\n3. Ongoing systemic therapy for cGvHD other than corticosteroids, calcineurin inhibitor, or mycophenolate mofetil, aside from fewer than 3 weeks of ruxolitinib. Prior ruxolitinib use for the indication of acute GVHD is permitted.\n4. Patients with relapsed primary malignancy, or who have been treated for relapse after the allogeneic HCT was performed\n5. SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Patients who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n6. History of progressive multifocal leuko-encephalopathy (PML)\n7. Active uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection progression are present.\n8. Clinical evidence of active and clinically significant viral disease including HIV, CMV, HHV-6, HBV, HCV, or BK virus.\n9. Patients on mechanical ventilation or have a resting O2 saturation \\\u003C 90% by pulse oximetry\n10. Clinically significant and uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 3 months, or NYHA Class III or IV congestive heart failure.\n11. Uncontrolled hypertension with systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg.\n12. Creatinine clearance by Cockcroft-Gault of \\\u003C 15 mL\u002Fmin and not on dialysis\n13. Total bilirubin \\> 3 times ULN, ALT \\> 5 times ULN, or AST \\> 5 times ULN\n14. QTc ≥ 470 ms as calculated by the Fridericia Formula\n15. Active pregnancy or breast feeding, or currently seeking active pregnancy\n16. Any patient who, in the opinion of the investigator, may not be able to comply with study procedures","80 Years",{"count":262,"type":21},[433],"This is an open-label phase I study of fostamatinib in combination with ruxolitinib for the treatment of chronic GvHD with a suboptimal response to corticosteroids. The primary objective is to identify a minimum safe and biologically effective dose of fostamatinib when combined with standard of care ruxolitinib for the treatment of steroid refractory and steroid dependent cGVHD. The secondary objective is to estimate the efficacy of the combination of ruxolitinib and fostamatinib for the treatment of steroid refractory and steroid dependent cGVHD.\n\nThe target enrollment is 24-30 subjects. The study will begin with an initial dose escalation cohort employing a modified 3+3 design to investigate up to three doses of fostamatinib. Using safety, efficacy, pharmacodynamic (PD), and pharmacokinetic data (PK), an interim assessment will be performed to determine two candidate doses of the biologically optimal dose to investigate further. A safety expansion cohort will be opened to backfill these two candidate doses up to a total 12 patients per dose, including those in the dose escalation cohort who received the candidate doses. Patients will then be randomized to one of these two candidate doses in the expansion. If there is an imbalance in the two expansion cohorts, the remaining patient slots after 1:1 randomization will be sequentially backfilled to a total of 12 patients per cohort. A final analysis of safety, efficacy, and PK\u002FPD data in patients who received the two candidate doses will be conducted to determine a minimum safety and biologically effective dose, which will be the recommended phase II dose (RP2D).\n\nThe primary hypothesis is that Fostamatinib combined with ruxolitinib is a safe therapy for and has synergistic activity in cGvHD. The recommended phase II dose will be determined by the study investigators in collaboration with the sponsors. The decision to select the recommended phase II dose will occur only after all patients in the part 1 have completed at least 28 days of therapy. The decision will be based on the valuation of all relevant, available data, and not solely on dose-limiting toxicities.",[56],"2026-01-21",{"date":459,"type":34},"2026-01-22",{"date":461,"type":34},"2025-10-29",{"date":463,"type":21},"2029-07-01",{"name":465,"class":68},"Stefanie Sarantopoulos, MD, PhD.",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":413},"100603567","phase-1-a-study-to-evaluate-adrixetinib-q702-in-adults-with-active-chronic-graft-versus-host-disease-100603567","NCT07138196","A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease","A Phase 1b, Open-label Dose Escalation Study to Evaluate the Safety, Pharmacodynamic, Pharmacokinetic and Preliminary Efficacy of Q702 in Subjects With Relapsed or Refractory Active Chronic Graft-versus-Host Disease (cGVHD)","Inclusion Criteria:\n\n1. Subjects who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression.\n2. Subjects with relapsed or refractory active cGVHD who have progressed after all available standard of care treatments.\n3. Subject must have documented progressive disease as defined by the NIH 2014 consensus criteria, in terms of either organ specific algorithm or global assessment, or active, symptomatic cGVHD for which the treating physician believes that a new line of systemic therapy is required.\n4. Adequate organ and bone marrow functions.\n5. Karnofsky Performance Scale of ≥ 60.\n\nExclusion Criteria:\n\n1. Exposure to CSF1R inhibitor therapy for any indication after allogeneic transplant.\n2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer.\n3. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment.\n4. Female subject who is pregnant or breastfeeding.\n5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy",{"count":474,"type":21},18,[433],"Open-label, dose escalation study to evaluate safety, tolerability pharmacokinetic and pharmacodynamic activity, and efficacy of Adrixetinib (Q702) in subjects with relapsed or refractory active chronic graft-versus-host disease (cGVHD).",[266],"2025-12-24",{"date":480,"type":34},"2025-12-30",{"date":482,"type":34},"2025-12-23",{"date":484,"type":21},"2029-10-31",{"name":486,"class":41},"Qurient Co., Ltd.",{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":69},"100535078","tissue-immune-landscape-of-graft-versus-host-disease-after-allogeneic-stem-cell-transplantation-til-gvhd-100535078","NCT06247150","Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)","TIL-GVHD","Inclusion Criteria:\n\n* Patient \\> 18 yo ;\n* Having undergone an allogeneic stem cell tranplant ;\n* 2 groups of patients will be eligible\n* showing evidence of primary cGVHD or occuring after Donor Lymphocyte Infusion\n\n  * in the case of first occurrence of cGVHD, in the absence of any new systemic therapy ;\n  * in the case of recurrent cGVHD, steroid dose has to be below 15mg\u002Fday of Prednisone ;\n* Having read, understood and signed an informed consent of the study;\n* With social security affiliation;\n\nExclusion Criteria:\n\n* Patient below 18 yo or unable to give consent ;\n* Systemic therapy using steroids over 15mg\u002Fd of Prednisone ; and\u002For the use of other systemic agent introduced in the last month ;\n* Haemorrhagic risk of biopsy anticipated ;\n* Absence of patient agreement for the study",{"count":495,"type":21},70,[53],"Graft versus Host Disease (GVHD) is frequent after allogeneic stem cell transplantation (alloSCT). GVHD occurs following 2 patterns : acute GVHD (aGVHD) or chronic GVHD (cGVHD). The latter occurs in nearly 50% of patients and its pathogenesis remains poorly understood. Previous translational studies have delineated biological immune dysregulation involved in cGVHD and facilitated the development of new drug and therapeutic strategies. New aspects of T and B cells collaboration in the context of cGVHD using blood description of a key player called TFH, classicaly involved in germinal center reaction, were previously uncovered (Forcade et al, Blood 2016). Previous studies in the context of auto-immune inflammation (lupus nephritis) or organ transplant rejection, suggested that target tissue could contain accessory lymphoid structures (TLS). The description of such structures in cGVHD target tissue would give the opportunity to directly analyze immune key player involved the pathogenesis of cGVHD.",[56],[500,501,502,503],"Chronic GVHD","Biopsy","TFH","Tertiary lymphoid structures","2025-08-05",{"date":374,"type":34},{"date":507,"type":34},"2024-05-21",{"date":509,"type":21},"2026-06",{"name":511,"class":68},"University Hospital, Bordeaux",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":520,"briefSummary":521,"conditions":522,"keywords":523,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":69},"100593889","phase-1-gecacitinib-for-cgvhd-safety-and-efficacy-in-patients-after-2-lines-of-prior-therapy-100593889","NCT07012304","Gecacitinib for cGVHD: Safety and Efficacy in Patients After ≥2 Lines of Prior Therapy","A Study on the Safety and Efficacy of Gecacitinib in Patients With Chronic Graft-versus-Host Disease (cGVHD) Who Have Received Prior Treatment With Two or More Systemic Therapies","Inclusion Criteria:\n\n* Voluntarily Signed informed consent and aged ≥18 years\n* Undergone nonmyeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow, peripheral blood stem cells, or umbilical cord blood from any donor source\n* Confirmed myeloid and platelet engraftment: ANC \\>1.0×10⁹\u002FL and platelet count \\>25×10⁹\u002FL; no hematopoietic growth factors or blood product transfusions within 7 days before screening\n* Clinically diagnosed moderate-to-severe cGVHD according to the 2014 NIH\n* Received 2-5 prior systemic cGVHD therapies with persistent disease\n* ECOG PS score of 0-2\n* Able to swallow tablets\n* Concomitant use of non-interacting immunosuppressants permitted\n\nExclusion Criteria:\n\n* Recurrence of malignancy or loss of full donor chimerism\n* Concurrent use of other JAK inhibitors, mesenchymal stem cells, or belumosudil (Eligible if discontinued for \\>8 weeks post-aGVHD treatment or stopped JAK inhibitors for cGVHD due to side effects.)\n* Severe pulmonary cGVHD (FEV1 ≤39% or NIH lung symptom score of 3)\n* Post-transplant lymphoproliferative disease\n* Significant abnormalities affecting safety assessment, such as uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite ≤2 antihypertensives; ALT\u002FAST \\>3×ULN; DBIL\u002FTBIL \\>1.5×ULN; serum creatinine \\>1.5×ULN\n* History of major cardiovascular events within 6 months.\n* Arrhythmia requiring treatment at screening\n* Gastrointestinal conditions impairing drug absorption\n* Surgery within 4 weeks of screening with incomplete recovery\n* Active\u002Funcontrolled infections (viral, bacterial, parasitic, fungal) requiring treatment\n* Active tuberculosis within 6 months\n* Epilepsy or use of psychotropic\u002Fsedative drugs\n* Pregnant\u002Fbreastfeeding or unwilling to use contraception during and 4 weeks post-study\n* Malignancy within 5 years (except the indication for transplant)\n* Use of anticoagulants\u002Fplatelet inhibitors (except low-molecular-weight heparin)\n* Herbal medicine use within 1 week prior to enrollment\n* Hypersensitivity to gecacitinib or its components\n* Participation in another clinical trial within 4 weeks (or 5 half-lives of the previous study drug, whichever is longer)\n* Deemed unsuitable by the investigator",{"count":5,"type":21},[433,80],"Chronic Graft-versus-Host Disease (cGVHD) is a common late complication following allogeneic hematopoietic stem cell transplantation and a leading non-relapse cause of death. It is often treatment-refractory, significantly affecting patients' quality of life and prognosis. This study will evaluate the feasibility, safety, and tolerability of gecacitinib, a novel JAK and ACVR1 inhibitor, in 24 patients with moderate-to-severe cGVHD who have undergone two or more prior therapies. Participants will receive gecacitinib hydrochloride tablets for at least 24 weeks. Patients demonstrating disease stability, as assessed by the investigator, may continue treatment with the study drug until week 60, unless intolerability, disease progression, or initiation of new systemic therapy, whichever occurs first.",[56],[29,524,525],"JAK inhibitor","Gecacitinib","2025-06-06",{"date":528,"type":34},"2025-06-10",{"date":530,"type":21},"2025-06-30",{"date":532,"type":21},"2029-02-28",{"name":534,"class":68},"Yujun DONG",{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":542,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":556},"100539167","phase-2-a-clinical-trial-of-tq05105-tablets-in-the-treatment-of-chronic-graft-versus-host-disease-100539167","NCT06300320","A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease","A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).","Inclusion Criteria:\n\n* Voluntary and signed informed consent, good compliance;\n* Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.\n* Received allogeneic hematopoietic stem cell transplantation;\n* Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)\n* Received systemic therapies for cGVHD;\n* Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;\n* Absolute Neutrophil Count (ANC) ≥ 1.0×10 9\u002FL ；platelet count (PLT) ≥30×10 9 \u002FL; Hemoglobin ≥80g\u002FL; There were no obvious abnormalities in liver and kidney function and coagulation function;\n* Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study\n\nExclusion Criteria:\n\n* Currently present or occured other malignancies within 3 years prior to first administration;\n* Known or suspected active acute graft versus host disease (aGVHD);\n* Presence of infection requiring treatment within 7 days prior to randomization;\n* Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;\n* Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;\n* Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;\n* Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;\n* Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;\n* Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;\n* Those who are allergic to the study drug or its components;\n* Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;\n* Subjects judged by the investigator to be unsuitable for enrollment;","70 Years",{"count":544,"type":21},52,[80],"This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease",[56],"2025-02-09",{"date":550,"type":34},"2025-02-11",{"date":552,"type":34},"2024-05-07",{"date":353,"type":21},{"name":555,"class":41},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",12,{"id":558,"slug":559,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":260,"enrollmentInfo":564,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":69},"100279500","phase-2-therapeutic-effects-of-hydrogen-on-steroid-refractoryor-steroid-dependent-cgvhd-100279500","NCT02918188","Therapeutic Effects of Hydrogen on Steroid-refractory\u002For Steroid-dependent cGVHD","Therapeutic Effects of Hydrogen on Steroid-refractory\u002For Steroid-dependent Chronic Graft-versus-host-disease","Inclusion Criteria:\n\n* Written informed consent\n* Male\n* not pregnant female\n* patients \\\u003C65 years old\n* Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg\u002Fkg ) or steroid-dependent cGVHD (had an initial response followed by a cGVHD flare upon steroid taper)\n* Patient intolerant to steroid therapy\n\nExclusion Criteria:\n\n* Patients with stable disease, not well controlled by the current treatment\n* Pregnancy\n* HIV positive\n* Severe liver or renal impairment: serum creatinine \\>2.5 mg\u002Fdl; serum bilirubin\\>2.5 mg\u002Fdl (without evidence of hepatic cGVHD)\n* Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy\n* Any other investigational agents administered within last four weeks\n* Cardiac insufficiency (\\>grade II, New York Heart Association classification)\n* Inability to comply with medical therapy or follow-up",{"count":565,"type":21},21,[80],"This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.",[569],"Chronic Graft-versus-host Disease","2020-07-17",{"date":572,"type":34},"2020-07-21",{"date":574,"type":4},"2016-01",{"date":576,"type":21},"2031-01",{"name":578,"class":68},"Navy General Hospital, Beijing","Chronic Graft-Versus Host Disease"]