[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"graft-vs-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:graft-vs-host-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,47,78,115,145,170,195,218,242,305,331,354,381,408,431,455,488,520,544,564,590,615],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100480115","phase-1-phase-iii-study-of-pacritinib-a-jak2irak1csf1r-inhibitor-in-refractory-chronic-graft-versus-host-disease-cgvhd-after-allogeneic-hematopoietic-stem-cell-transplantation-hsct-100480115",false,"NCT05531786","Phase I\u002FII Study of Pacritinib, A JAK2\u002FIRAK1\u002FCSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","-INCLUSION CRITERIA:\n\n1. Moderate or severe cGVHD (after allogeneic hematopoietic stem cell transplantation) diagnosed and staged per NIH criteria\n2. cGVHD that did not respond to \\>=2 lines of prior systemic therapy.\n\n   Disease that has failed prior systemic therapy will be defined as follows:\n\n   a) For prior corticosteroid-containing regimens, disease that:\n\n   i) recurs after achievement of a CR, or\n\n   ii) progresses after achievement of a PR, or\n\n   iii) progresses after at least 1 week of prednisone equivalent of 1 mg\u002Fkg\u002Fday, or\n\n   iv) is stable and persistent after at least 4 weeks of a prednisone equivalent of 0.5 mg\u002Fkg\u002Fday\n\n   OR,\n\n   b) For other systemic therapies, disease that:\n\n   i) recurs after achievement of CR, or\n\n   ii) progresses after achievement of a PR, or\n\n   iii) is stable and persistent despite 4 weeks of therapeutic dosing of systemic therapy\n3. Karnofsky performance score \\>=60%\n4. Age \\>=18 years.\n5. If participant is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering dose in the preceding 4 weeks.\n6. Participants must have adequate organ and marrow function as defined below:\n\n   * absolute neutrophil count \\>=1,000\u002FmcL\n   * platelets \\>=50,000\u002FmcL\n   * total bilirubin \\\u003C=1.5 X institutional upper limit of normal\n\n   OR\n\n   \\\u003C=3 X institutional upper limit of normal in participants with Gilbert's syndrome\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C=3 X institutional upper limit of normal\n   * eGFR \\>= 35 mL\u002Fmin per CKD-EPI 2021\n7. Primary malignancy for which the participant received transplant has been in complete clinical remission and stable for 3 months prior to enrollment on study.\n8. Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant who are sexually active must agree to use one (1) highly effective (e.g., intrauterine system containing levonorgestrel intrauterine devices, surgical) or two (2) effective forms of contraception (e.g., barrier method) at study entry, for the duration of study treatment, and for at least 30 days after last study drug exposure.\n9. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Acute GVHD that is active as defined by exhibiting current signs or symptoms of disease without any chronic GVHD (classic and late-acute GVHD per NIH consensus criteria); participants with a clinical presentation consistent with overlapping acute GVHD with concurrent chronic GVHD will be eligible\n2. Treatment with ruxolitinib within 24 hours, or ibrutinib within the \\\u003C=14 days prior to treatment initiation.\n3. Active HIV-1 (detectable HIV viral load), or Hepatitis B (HBV) and\u002For Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody).\n4. Participants with the following cardiac conditions at screening:\n\n   * symptomatic congestive heart failure\n   * unstable angina pectoris\n   * uncontrolled cardiac dysrhythmias\n   * QTc(F) prolongation \\>450 ms or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome).\n5. Left ventricular ejection fraction \\\u003C= 50% by transthoracic echocardiogram (TTE) at screening.\n6. Participants with poor pulmonary function as defined by a forced expiratory volume in the first second (FEV1) \\\u003C= 39% calculated using the USA-ITS-NIH equation.\n7. Participants with evidence of ongoing hemorrhage, active signs\u002Fsymptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.\n8. Concurrent treatment with any other investigational agents.\n9. Concurrent use of strong CYP3A4 inducers or inhibitors, must stop 2 weeks prior study drug initiation.\n10. Known hypersensitivity to JAK inhibitors.\n11. Participants who are unwilling to accept blood transfusions.\n12. Pregnancy or breastfeeding.\n13. Participants with any active, uncontrolled viral, bacterial, or fungal infection are excluded.\n14. Other malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix or breast which requires active treatment.\n15. Uncontrolled intercurrent illness evaluated by history, physical exam and chemistries or situation that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Background:\n\nChronic graft-versus-host disease (cGVHD) is an immune system disorder that can occur in people who have had a stem cell transplant. cGVHD can affect multiple organs and increase risk of disability and death. New treatments are needed to treat cGVHD after stem cell transplant.\n\nObjective:\n\nTo test a drug (pacritinib) in people with moderate or severe cGVHD that has not responded to previous treatment.\n\nEligibility:\n\nPeople aged 18 years and older with moderate or severe cGVHD that has not responded to 2 or more lines of previous treatment.\n\nDesign:\n\nParticipants will be screened. They will have blood and urine tests. They will have tests of their heart and lung function. They may also have a CT scan. Some may have other specialized tests.\n\nParticipants will take the study drug at home every day. Pacritinib is a capsule taken by mouth. The study doctor will determine the dosage and schedule.\n\nParticipants will keep a medication diary. They will record the date and time of each drug dose and any missed doses.\n\nParticipants will visit the clinic every 2 weeks for the first 4 months. Then they will visit the clinic once every 4 weeks. They will have blood and urine tests. During some visits, other screening tests will be repeated, and participants will fill out questionnaires about their quality of life. Photographs may be taken of skin rashes and joints affected by cGVHD.\n\nParticipants will give saliva samples. Optional biopsies may be taken of the skin and mouth.\n\nParticipants will take pacritinib for 6 to 12 months if no side effects develop. Follow-up visits will continue for up to 2 years.\n\n...",[27],"Graft vs Host Disease",[29,30,31,32,33],"Anti-Inflammatory","Fibrosis","Inflammation","Refractory","Systemic Therapy","RECRUITING","2026-07-01",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2023-03-06",{"date":42,"type":20},"2027-07-22",{"name":44,"class":45},"National Cancer Institute (NCI)","NIH",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100593443","phase-2-a-study-of-belumosudil-in-people-at-risk-of-developing-graft-versus-host-disease-after-a-stem-cell-transplant-100593443","NCT07006506","A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant","Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Patients ≥ 18 years-old at time of consent.\n* Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).\n* Recipients of 7-8\u002F8 related or unrelated HLA-matched or related haploidentical donor.\n* Peripheral blood stem cell graft\n* Allo-HCT day \\\u003C120 at time of consent\n\nPost-HCT inclusion criteria (within 3 weeks before start of belumosudil treatment)\n\n* Patient has received an allo-HCT transplant and is in morphologic remission (blasts \\\u003C5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed.\n* Patient has achieved engraftment. Engraftment is defined as ANC≥500\u002FμL and platelets ≥ 20000\u002FμL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.\n* Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.\n* Karnofsky score ≥ 70%.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)\n* Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).\n* Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Female subjects of childbearing potential (≤ 50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.\n\n  ° Sexually active females of childbearing potential enrolled in the study must agree to consistently 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: \\* Intrauterine device (IUD) plus one barrier method \\* Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method \\* 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \\* 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\nExclusion Criteria:\n\n* Recipient of CD34+ selected or engineered stem cell graft.\n* Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).\n* Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n* Pulmonary dysfunction with DLCO \\\u003C50% corrected for hemoglobin\n* Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.\n\nPost-HCT exclusion criteria\n\n* Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.\n* Use of investigational agent within 14 days pre-HCT or anytime thereafter.\n* Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).\n* Active treatment with corticosteroids at a dose of ≥ 0.25 mg\u002Fkg\u002Fday for non-GVHD indication.\n* Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year\n* Female patient who is pregnant or breastfeeding.\n* Prior therapy with belumosudil.\n* Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.",{"count":55,"type":20},46,[24],"The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.",[59,60,61],"Graft Versus Host Disease","Graft Vs Host Disease","Hematologic Malignancy",[59,60,61,63,64,65,66,67],"Hematologic malignancy in morphologic remission","Belumosudil","Stem Cell Transplant","Memorial Sloan Kettering Cancer Center","25-033","2026-06-25",{"date":70,"type":38},"2026-06-29",{"date":72,"type":38},"2025-05-21",{"date":74,"type":20},"2029-05-21",{"name":66,"class":76},"OTHER",8,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":5},"100579423","phase-4-study-of-efficacy-and-safety-of-ruxolitinib-in-chinese-participants-with-corticosteroid-refractory-chronic-graft-vs-host-disease-100579423","NCT06824103","Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease","A Single-arm Multi-center Study of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft Versus Host Disease After Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Male or female Chinese participants aged 12 or older at the time of informed consent\n* Able to swallow tablets.- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.\n* Evident myeloid and platelet engraftment:\n\n  * Absolute neutrophil count (ANC) \\>1,000\u002Fmm3 AND\n  * Platelet count ≥25,000\u002Fmm3\n\nNote: Use of growth factor supplementation and transfusion support is allowed during the trial, however, transfusion to reach a minimum platelet count for inclusion is not allowed during screening and at baseline.\n\n* Participants with clinically diagnosed cGvHD staging of moderate to severe according to NIH Consensus Criteria (Jagasia et al 2015) prior to Cycle 1 Day 1.\n\n  * Moderate cGvHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.\n  * Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3.\n* Participants currently receiving systemic corticosteroids for the treatment of cGvHD for a duration of \\\u003C 12 months prior to Cycle 1 Day 1, and have a confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin et al 2015) irrespective of the concomitant use of a calcineurin inhibitor, as follows:\n\n  * A lack of response or disease progression after administration of minimum prednisone 1 mg\u002Fkg\u002Fday for at least 1 week (or equivalent) OR\n  * Disease persistence without improvement despite continued treatment with prednisone at \\>0.5 mg\u002Fkg\u002Fday or 1 mg\u002Fkg\u002Fevery other day for at least 4 weeks (or equivalent) OR\n  * Increase to prednisone dose to \\>0.25 mg\u002Fkg\u002Fday after two unsuccessful attempts to taper the dose (or equivalent)\n* Participants has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n\nExclusion Criteria:\n\nFor a full list of exclusion criteria, refer to Section 5.2. Key exclusion criteria include\n\n* Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD.\n* Participants who have received ROCK2 inhibitors for cGvHD.\n* Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment\n\nNote: Participants receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.\n\n* Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1.\n* Failed prior alloSCT within the past 6 months from Cycle 1 Day 1.\n* Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed.\n* SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n\nOther protocol-defined inclusion\u002Fexclusion may apply.","12 Years","100 Years",{"count":19,"type":20},[89],"PHASE4","The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).",[92,93,94],"Graft vs. Host Disease","Chronic Graft vs. Host Disease","Corticosteroid-refractory Chronic Graft vs. Host Disease",[96,97,98,99,100,101,102,103,104],"cGvHD","GvHD","SR-cGvHD","ruxolitinib","INC424","Chinese adult","Pediatric","Corticosteroid","refractory","2026-06-04",{"date":107,"type":38},"2026-06-08",{"date":109,"type":38},"2025-09-09",{"date":111,"type":20},"2031-05-23",{"name":113,"class":114},"Novartis Pharmaceuticals","INDUSTRY",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":15,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":4,"leadSponsor":142,"locationsCount":144},"100065731","long-term-evaluation-and-follow-up-care-of-patients-treated-with-stem-cell-transplants-100065731","NCT00106925","Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants","Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants","* INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:\n\nPatients surviving three years or more from date of first stem cell transplant who have been treated.\n\n-With an experimental allogeneic stem cell transplant on a NHLBI HB protocol\n\nOr\n\n-With a standard of care allogeneic stem cell transplant on an NHLBI protocol\n\nOr\n\n-Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team\n\nAge greater than or equal to 7 years old and age less than or equal to 80\n\nFor adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.\n\nEXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS:\n\nNone, all patients meeting the inclusion criteria will be eligible",true,"7 Years","80 Years",{"count":126,"type":20},1000,"OBSERVATIONAL","This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.\n\nPatients between 10 and 80 years of age who received a donor stem cell transplant at the NIH Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.\n\nParticipants are generally seen in the clinic every 12 months for some or all of the following procedures:\n\n* Periodic physical examinations, eye examinations, and blood and urine tests.\n* Bone marrow aspiration and biopsy: A sample of bone marrow is obtained for microscopic examination. The patient is given local anesthesia or conscious sedation. An area of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.\n* Tissue biopsy: A small piece of tissue or tumor is obtained for microscopic examination. Depending on the site of the biopsy, the tissue may be removed using a cookie cutter-like \"punch\" instrument, a needle, or a knife. The area is numbed and the tissue is removed with the appropriate tool.\n* Imaging tests to visualize organs, tissues, and cellular activity in specific tissues. For these tests, the patient lies on a table that slides into the scanner. They may include the following:\n\n  1. Nuclear scans use a sensitive camera to track a small amount of radioactive material (radioisotope) that is given to the patient by mouth or through a vein. The scan may show abnormal areas of tissue in the bones, liver, spleen, kidney, brain, thyroid, or spine.\n  2. Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine small sections of body organs and tissues.\n  3. Computerized tomography (CT) uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs.\n  4. Positron emission tomography (PET) uses a fluid with a radioisotope attached to it to show cellular activity in specific tissues. The fluid is given through a vein and travels to the cells that are most active (like cancer cells), showing if there is an actively growing tumor.\n* Pulmonary (lung) function tests: The patient breathes into a machine that measures the volume of air the person can move into and out of the lungs.\n* Heart function tests may include the following:\n\n  1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.\n  2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.\n  3. Multiple gated acquisition scan (MUGA) is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.\n\nDisease relapse or progression, or transplant-related problems may be treated with standard medical, radiation, or surgical therapy, or patients may be offered experimental therapy.",[130,27,131],"Graft-versus-leukemia","Graft Rejection",[133,134,59,135,136,137],"Peripheral Blood Stem Cells","Graft Versus Leukemia\u002FMyeloma","Whole Body Irradiation","Leukemic Relapse","Natural History","2026-06-03",{"date":105,"type":38},{"date":141,"type":38},"2005-04-22",{"name":143,"class":45},"National Heart, Lung, and Blood Institute (NHLBI)",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100636743","phase-4-letermovir-prophylaxis-duration-guided-by-cmv-specific-t-cell-monitoring-after-allo-hsct-100636743","NCT07569653","Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.","A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.","Inclusion Criteria:\n\n1. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n2. CMV serostatus of the recipient is positive (R+).\n3. Aged 18 years or older.\n4. Expected survival \\> 6 months.\n5. Provision of signed informed consent.\n\nExclusion Criteria:\n\n* 1.Active CMV infection or CMV disease at the time of screening.\n\n  2.Known hypersensitivity to Letermovir or its excipients.\n\n  3.Severe hepatic or renal impairment.\n\n  4.Pregnant or breastfeeding women.",{"count":153,"type":20},120,[89],"The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus \\[CMV\\] infection) based on the recovery of the patient's own immune system.\n\nCytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typically given as a standard prevention for about 100 days post-transplant. However, some patients may recover their CMV-specific immunity earlier, while others may need longer protection.\n\nIn this study, researchers will use a dynamic monitoring technology (QuantiFERON-CMV) to detect the level of CMV-specific T-cells in patients. Participants will be randomly assigned to either the experimental group or the control group:\n\nExperimental Group: Letermovir discontinuation will be guided by T-cell recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.\n\nControl Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.\n\nThe study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.",[157,158,159,27],"Cytomegalovirus Infections","Cytomegalovirus Disease","Hematopoietic Stem Cell Transplantation","2026-05-27",{"date":162,"type":38},"2026-06-01",{"date":164,"type":38},"2025-10-30",{"date":166,"type":20},"2027-12",{"name":168,"class":76},"WeiShi",12,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":144},"100620976","phase-2-fecal-microbiota-transplantation-for-steroid-refractory-acute-gi-gvhd-100620976","NCT07364617","Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD","Fecal Microbiota Transplantation for the Treatment of Steroid Refractory Acute Gastrointestinal Graft-Versus-Host Disease in Patients After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Stage II to IV steroid refractory acute GI-GvHD in allo-HSCT recipients\n\n   1. Stage II to IV acute GI-GVHD subjects, having \\>1000 mL stool per day, diarrhea \\> 5 times\u002Fday, or abdominal cramping, bleeding or ileus, AND\n   2. Resistant to a first-line therapy with corticosteroids (CS)\n\n   \u003C!-- -->\n\n   1. Lack of improvement after 5 days of treatment with CS at 2 mg\u002Fkg\u002Fd methylprednisolone or other CS with equivalent dose,\n   2. Progression after 3 days of treatment with CS at 2 mg\u002Fkg\u002Fd methylprednisolone or other CS with equivalent dose.\n2. Age ≥ 18 years old.\n3. Allo-HSCT with any type of donor, stem cell source, GvHD prophylaxis or conditioning regimen.\n4. Allow vancomycin-resistant enterococcus (VRE) colonization and asymptomatic cytomegalovirus (CMV) viremia, which is defined as a detectable CMV viral load in plasma but without tissue-invasive disease.\n5. Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT (antiviral and antifungal agents are allowed)\n6. Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship. Subject must understand and voluntarily sign an informed consent form prior to any study-related assessments\u002Fprocedures being conducted.\n\nExclusion Criteria:\n\n1. Absolute neutrophil count \\\u003C 500 cells\u002FuL.\n2. Absolute platelet count \\\u003C 30000 \u002FuL which is not correctable by transfusion\n3. Hemodynamically unstable status with the following conditions: systolic blood pressure \\\u003C 90 mm Hg, pulse oximeter oxygen saturation (SpO2) \\\u003C 90%, PaO2 \\\u003C 60 mm Hg, or respiratory rate \\> 22\u002Fminute.\n4. Uncontrolled and active infection from bacteria, virus, or fungus as determined by the investigators.",{"count":178,"type":20},35,[24],"Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for various hematologic diseases. However, one of the major challenges of allo-HSCT is the occurrence of graft-versus-host disease (GvHD), particularly acute gastrointestinal GvHD (GI-GvHD). GvHD occurs when donor T cells recognize the recipient's tissue as foreign and mount an immune attack against it. Acute GI-GvHD is a common complication following allo-HSCT and a significant cause of mortality. If the initial steroid treatment for acute GvHD fails, mortality rates can reach as high as 81%.\n\nRecent studies have shown a strong association between reduced gut microbiota diversity and high mortality in patients with acute GI-GvHD, highlighting the critical role of the gut microbiome in regulating immune responses and maintaining intestinal homeostasis. Consequently, fecal microbiota transplantation (FMT) has emerged as a potential therapeutic strategy aimed at restoring a healthy gut microbiome and improving clinical outcomes in patients with acute GI-GvHD.\n\nThis study aims to evaluate the efficacy and safety of FMT in patients with steroid-refractory or steroid-resistant acute GI-GvHD. The findings of this research will contribute to establishing FMT as a potential and effective treatment option for managing severe acute GI-GvHD, thereby improving patient outcomes and reducing transplant-related mortality.",[27],[183,184,185],"Acute Gastrointestinal Graft-versus-Host Disease","fecal microbiota transplantation","steroid-refractory","2026-05-21",{"date":188,"type":38},"2026-05-22",{"date":190,"type":38},"2026-04-29",{"date":192,"type":20},"2028-02-28",{"name":194,"class":76},"Chang Gung Memorial Hospital",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":15,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":144},"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":205,"type":20},30,[24],"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.",[209,27],"Chronic Graft-Versus-Host Disease","2026-05-18",{"date":212,"type":38},"2026-05-26",{"date":214,"type":38},"2025-09-01",{"date":216,"type":20},"2029-09-01",{"name":168,"class":76},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":15,"minAge":226,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100391727","phase-2-extended-vs-short-term-abatacept-dosing-for-graft-versus-host-disease-prophylaxis-100391727","NCT04380740","Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis","A Randomized Double-Blind Trial of Abatacept Extended Dosing Versus Abatacept Short-term Dosing for Graft Versus Host Disease Prophylaxis: \"ABA3\"","ABA3","Inclusion Criteria:\n\n1. Must be at least 2 years old and weigh 10 kg.\n2. Must have a willing unrelated adult donor (bone marrow or peripheral blood). Donors may have a single mismatch (i.e. be a 7\u002F8) and this mismatch may be at the allele or antigen level; however, donors with allele level disparity should be given preference over those with antigen level disparity. Patients for whom a donor is available with disparity only in the host versus graft direction (because of recipient homozygosity), will not be eligible, since this mismatching does not increase the risk for GVHD. Centers may perform extended typing (e.g. DQB1 and DPB1) according to institutional practices and use these results in selecting donors; however, it is recommended that this extending typing be used only to select between donors who are equally well matched with the recipient at the A, B, C and DRB1.\n3. All patients and\u002For their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.\n4. Must have a hematologic malignancy treatable by HCT (except for those stipulated below under study Exclusion Criteria), which is in remission by standard testing (no patients in relapse will be included).\n5. Patients with an inherited predisposition to leukemia or otherwise hematologic malignancies that have not been associated with predisposition to transplant morbidities or non-hematologic cancers.\n6. Karnofsky performance score or Lanskey Play-Performance Scale score \\>\u002F= 80.\n\n   * If the patient does not meet defined eligibility requirements, the PI\u002Fstudy committee must be contacted to determine eligibility.\n\nExclusion Criteria:\n\n1. Patients with the following hematologic malignancies will be excluded: Chronic Lymphocytic Leukemia, Myeloma and Primary Myelofibrosis.\n2. Active Relapse (\\>5% blasts) of their primary malignancy.\n3. For patients with Acute Lymphocytic Leukemia (ALL) with pre-transplant MRD testing performed as standard practice at the treating institution, patients with MRD \\>0.01% will be ineligible.\n4. For patients with Acute Myeloid Leukemia (AML) with pre-transplant MRD testing as standard of practice at the treating institution, patients with any MRD status are eligible and should be enrolled at the discretion of provider.\n5. For patients with MDS, those with \\>5% blasts will be excluded.\n6. Prior allogeneic HCT.\n7. Uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment.\n8. HIV infection.\n9. Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression.\n10. Prisoners or others who are compulsorily detained.\n11. Any patient with a known or suspected inherited predisposition to cancer should be discussed with the study team prior to screening for eligibility.\n\n    1. Patients with a known inherited or constitutional predisposition to transplant morbidities, including, but not limited to Fanconi Anemia, Dyskeratosis Congenita, Shwachman-Diamond Syndrome and Down Syndrome will be excluded.\n    2. Patients with known inherited or constitutional predisposition to non-hematologic cancers including, but not limited to Li-Fraumeni syndrome, BRCA1 and BRCA2 mutations will be excluded.\n12. Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, and are disease free for \\\u003C2 years.\n13. Incompletely treated active tuberculosis Infection.\n14. Pregnancy (positive serum b-HCG) or breastfeeding.\n15. Estimated GFR of \\\u003C 50 mL\u002Fmin\u002F1.73m2.\n16. Cardiac ejection fraction \\\u003C 50 (using M-Mode if assessment is done by ECHO)\n17. T.bilirubin \\> 2 × upper limit of normal or ALT \\> 4 × upper limit of normal or unresolved veno-occlusive disease.\n18. Pulmonary disease with FVC, FEV1 or DLCO parameters \\\u003C45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen.\n19. Presence of antibodies to a mismatched donor HLA antigen (please refer to Section 3.4.g).\n20. Patients who have developed severe AGVHD, severe CGVHD or relapse will be excluded at the time of randomization.\n21. Exclusion Criteria Prior to Randomization (prior to 5th dose of abatacept\u002Fplacebo):\n\n    1. Severe allergic reaction during the first 4 doses of abatacept\n    2. If any clinical events occur that preclude further dosing of abatacept, those patients will be deemed ineligible for randomization","2 Years",{"count":228,"type":20},160,[24],"This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant.",[60],"2026-05-07",{"date":234,"type":38},"2026-05-11",{"date":236,"type":38},"2022-03-30",{"date":238,"type":20},"2028-06",{"name":240,"class":76},"Boston Children's Hospital",15,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100611443","phase-4-outcomes-from-hyperbaric-oxygen-hbo2-treatment-for-emerging-indications-100611443","NCT07240649","Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications","Emerging Indications for Hyperbaric Oxygen Treatment","Inclusion Criteria:\n\n* Patients referred for HBOT with an emerging indication\n\nExclusion Criteria:\n\n* Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)\n* Pregnant persons",{"count":250,"type":20},100,[89],"This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.",[254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294],"Post-COVID-19 Condition","Ulcerative Colitis","Crohn Disease","Calciphylaxis","Frostbite","Acute COVID-19","Pyoderma Gangrenosum","Pterygium","Hypospadias","Head Trauma","Pneumatosis Intestinalis","Ischemic Bowel","Raynaud Syndrome","Malignant Otitis Externa","Nonarteritic Anterior Ischemic Optic Neuropathy","Central Retinal Vein Occlusion","Femoral Head Necrosis","Invasive Fungal Infection","Chronic Anal Fissure","Vasculitic Ulcer","Graft-vs-Host Disease","Decubitus Ulcer","Greater Trochanteric Pain Syndrome","Rectovaginal Fistula","Pouchitis","Tinnitus","Clostridium Enterocolitis","Branch Retinal Artery Occlusion","Axonotmesis","Multiple Sclerosis","Inclusion Body Myositis","Epidermolysis Bullosa (EB)","Osteonecrosis","Ulcer Ischemic","Avascular Necrosis of Bone","Prosthesis Related Infections","Facial Filler Injections","Cystitis Chronic","Ligament Injury","Anastomosis, Leaking","Cartilage Injury","NOT_YET_RECRUITING","2026-05-01",{"date":298,"type":38},"2026-05-05",{"date":300,"type":20},"2026-08",{"date":302,"type":20},"2035-12",{"name":304,"class":76},"Jay C. Buckey Jr.",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":144},"100516767","phase-1-ruxolitinib-with-and-without-ctla-4-ig-abatacept-for-the-prophylaxis-of-graft-versus-host-disease-and-cytokine-release-syndrome-after-t-cell-replete-haploidentical-peripheral-blood-hematopoietic-cell-transplantation-100516767","NCT06008808","Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation","An Open-Label Phase I Study of JAK Inhibitor Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation","Inclusion Criteria:\n\nPatients must meet the following criteria within 30 days prior to Day -3 unless otherwise noted.\n\n* Diagnosis of one of the hematological malignancies listed below:\n\n  * Acute myelogenous leukemia (AML) in complete morphological remission, complete remission with incomplete hematologic recovery, and complete remission with partial hematologic recovery (based on ELN Criteria47).\n  * Acute lymphocytic leukemia (ALL) in complete morphological remission (MRD negative by flow cytometry with sensitivity to ≤ 10-4).\n  * Myelodysplastic syndrome with ≤ 10% blasts in bone marrow.\n  * Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HD) in second or greater complete or partial remission.\n  * Myelofibrosis with ≤ 10% blasts in bone marrow. Up to five patients with myelofibrosis will be permitted in Regimen 1 and up to five in Regimen 2.\n  * AML in partial response. One patient will be enrolled in Regimen 1 given the prospect of potential benefit.\n* Planned treatment is T cell-replete peripheral blood haploidentical donor transplantation.\n* Available HLA-haploidentical donor who meets the following criteria:\n\n  * Blood-related family member, including (but not limited to) sibling, offspring, cousin, nephew, or parent. Younger donors should be prioritized.\n  * At least 18 years of age.\n  * HLA-haploidentical donor\u002Frecipient match by at least low-resolution typing per institutional standards.\n  * In the investigator's opinion, is in general good health and medically able to tolerate leukapheresis required for harvesting hematopoietic stem cells.\n  * No active hepatitis.\n  * Negative for HTLV and HIV.\n  * Not pregnant.\n  * Donor selection will be in compliance with FDA guidelines as provided in 21 CFR 1271 for donor eligibility https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FBiologicsBloodVaccines\u002FGuidanceComplianceRegulatoryInformation\u002FGuidances\u002FTissue\u002FUCM091345.pdf\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 x IULN.\n  * AST (SGOT) and ALT (SGPT) ≤ 3.0 x IULN.\n  * Creatinine ≤ 1.5 x IULN OR creatinine clearance ≥ 45 mL\u002Fmin\u002F1.73 m2 by Cockcroft-Gault Formula.\n  * Oxygen saturation ≥ 90% on room air.\n  * LVEF ≥ 40%.\n  * FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted. If DLCO is \\\u003C 40%, patients will still be considered eligible if deemed safe after a pulmonary evaluation.\n* Able to receive GVHD prophylaxis with tacrolimus, mycophenolate mofetil (if applicable), and cyclophosphamide.\n* At least 18 years of age at the time of study consent\n* The effects of ruxolitinib and abatacept on the developing human fetus are unknown. Additionally, tacrolimus may increase risk of hypertension, preeclampsia, preterm birth, and low birth weight; and mycophenolate mofetil is considered to be teratogenic. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study.\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior allogeneic transplant (regardless of whether donor was related, unrelated, or cord). Prior autologous transplant is not exclusionary.\n* Presence of donor specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of ≥ 4000 as assessed by the single antigen bead assay.\n* Known HIV or active hepatitis B or C infection. Known current history of active tuberculosis.\n* Known hypersensitivity to one or more of the study agents.\n* Planning to receive antithymocyte globulin as part of the pre-transplant conditioning regimen.\n* Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug (Day -3).\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of Day -3.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disease, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmias.\n* Immunosuppressive doses of steroids. Subjects with steroids for adrenal insufficiency will not be excluded.",{"count":313,"type":20},41,[23],"Allogeneic hematopoietic cell transplantation (HCT) is one of the only curative intent therapies available for hematologic malignancies. HLA-matched sibling donors have historically offered the best clinical results but are unavailable for the majority of patients, while most patients do have readily available haploidentical donors. One of the risks of a haploidentical HCT is graft vs. host disease (GVHD), but it is difficult to reduce the incidence of GVHD without compromising the graft vs. leukemia (GVL) effect.\n\nThe hypothesis of this study is that JAK inhibition with and without CTLA-4 Ig with haploidentical HCT may mitigate GVHD and cytokine release syndrome while retaining the GVL effect and improving engraftment.",[60,317,59],"Graft-versus-host-disease",[319,320,321],"Haploidentical","GVHD","CRS","2026-04-21",{"date":324,"type":38},"2026-04-22",{"date":326,"type":38},"2024-05-07",{"date":328,"type":20},"2027-11-27",{"name":330,"class":76},"Washington University School of Medicine",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":144},"100388414","a-feasibility-study-using-clinimacs-for-alphabeta-t-cell-depletion-in-stem-cell-transplant-100388414","NCT04337515","A Feasibility Study Using CLINIMACS® for Alpha\u002FBeta T-Cell Depletion in Stem Cell Transplant","A Feasibility Study of Using the CiniMacs® Device for Alpha\u002FBest T-Cell Depletion in Stem Cell Transplant Recipients","Inclusion Criteria:\n\n* Male or female 0-30 years of age at time of transplant admission\n* Documentation of a disease requiring HCT\n* A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n* Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).\n* Patient with an anticipated life expectancy of \\\u003C1 month\n* Patients with known hypersensitivity to murine (mouse) proteins or iron dextran","30 Years",{"count":340,"type":20},90,[342],"NA","Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.",[60,317],"2026-04-06",{"date":347,"type":38},"2026-04-13",{"date":349,"type":38},"2019-12-19",{"date":351,"type":20},"2035-01-01",{"name":353,"class":76},"Christopher Dvorak",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":21,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":46},"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":363,"type":20},36,[342],"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",[60,367,368],"Acute-graft-versus-host Disease","Chronic Graft-versus-host-disease",[60,367,368,370,371],"Corticosteroids","Allogeneic stem cell transplant","2026-03-09",{"date":374,"type":38},"2026-03-11",{"date":376,"type":38},"2022-04-14",{"date":378,"type":20},"2027-09-09",{"name":380,"class":76},"Dana-Farber Cancer Institute",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":387,"minAge":16,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":144},"100565978","vulvovaginal-graft-versus-host-disease-diagnosis-and-microbiome-evaluation-100565978","NCT06649201","Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation","Inclusion Criteria:\n\n* Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period\n* All conditioning regimens (myeloablative or reduced intensity) will be included.\n* All donor sources (HLA matched\u002Fmismatched related, unrelated, umbilical cord, haploidentical) will be included.\n* All graft sources (bone marrow or peripheral blood stem cells) will be included.\n* All GVHD prophylaxis regimens will be included.\n* Aged 18-70.\n* English speaking and able to sign written informed consent.\n* Participants agree to a vaginal gynecologic exam.\n* Co-enrollment on other clinical trials will be allowed.\n\nExclusion Criteria:\n\n* Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.\n* Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.\n* Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome.\n* Participants with a history of lichen sclerosis, lichen planus, pre-transplant.\n* Participants with a history or current diagnosis of vaginal or vulvar malignancy.","FEMALE","70 Years",{"count":390,"type":20},40,"The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:\n\n* Is the vaginal microbiome altered during allogeneic HCT?\n* What changes may help researchers understand the development of vulvovaginal GVHD?\n\nParticipants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.",[60,393],"Vulvovaginal Signs and Symptoms",[395,396,320,397,398,399],"Allogeneic Hematopoietic Cell Transplantation","Vaginal Microbiome","HCT","Vulvovaginal GVHD","Vulvovaginal graft-versus-host disease","2026-03-05",{"date":372,"type":38},{"date":403,"type":38},"2024-12-19",{"date":405,"type":20},"2027-02-15",{"name":407,"class":76},"Case Comprehensive Cancer Center",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":122,"sex":15,"minAge":415,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":144},"100621059","fatigue-and-cognitive-dysfunction-due-to-synaptopathy-or-graft-versus-host-gvh-disease-in-the-brain-100621059","NCT07365696","Fatigue and Cognitive Dysfunction Due to Synaptopathy or Graft Versus Host (GVH) Disease in the Brain.","Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan.","Inclusion Criteria: PET images available retrospectively","20 Years","75 Years",{"count":205,"type":20},"Patients undergoing allogenic stem cell transplantation are regularly followed up in the outpatient clinic at Karolinska University Hospital. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Meanwhile liquor samples and advanced PET imaging techniques are available for these patients as part of a research project allowing extensive immunological and radio-morphological studies.",[420,60,421],"Fatigue","Cognitive Dysfunction","2026-01-19",{"date":424,"type":38},"2026-01-26",{"date":426,"type":38},"2023-11-28",{"date":428,"type":20},"2028-12-28",{"name":430,"class":76},"Karolinska University Hospital",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":416,"enrollmentInfo":438,"targetDuration":4,"studyType":21,"phases":439,"briefSummary":440,"conditions":441,"keywords":446,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":144},"100414575","phase-1-is-free-treg-haplohct-100414575","NCT04678401","IS-free Treg HaploHCT","A Pilot\u002FPhase 1 Study of Immunosuppression-free Regulatory T-cell Graft-engineered Haploidentical Hematopoietic Cell Transplantation in Relapsed\u002FRefractory and Ultra-High-risk AML\u002FMDS","Inclusion Criteria:\n\n* Cohort A: Histologically confirmed disease in the prior 4 weeks, despite at least 1 prior line of therapy (e.g., 3+7 chemotherapy, HMA therapy): Rel\u002Fref AML (de novo or secondary) with ≥5% blasts in BM (or extramedullary sites); MDS EB-2 (BM ≥10% blasts, PB 5-19% blasts).\n* Cohort B: Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with mutated TP53' per 2022 International Consensus Classification (Appendix L) regardless of response\n* Cohort C: Ultra high-risk AML or MDS that meets definition of 'Myeloid Neoplasms with multi-hit or complex karyotype (CK+) mutated TP53' per 2022 International Consensus Classification (Appendix L) with response: AML (de novo or secondary) with \\\u003C5% blasts in BM; MDS with \\\u003C10% blasts in BM or PB.\n* Available haploidentical HLA-matched (-A, -B, -C, -DRB1) related donor aged 18-65 years.\n* Age ≥18 to 65 years for Cohort A and B. Age ≥18 to 75 years for Cohort C. Because no dosing or adverse event data are currently available on the use of IS-free haploHCT in participants \\\u003C18 years of age, children are excluded from this study but will be eligible for future pediatric trials.\n* ECOG performance status ≤2 (Karnofsky ≥60, see Appendix A).\n* Adequate organ and marrow function as defined below:\n\n  * Pulmonary Function: FEV1, FVC and DLCO ≥ 60% of predicted (corrected for hemoglobin)\n  * Cardiac Ejection Fraction ≥ 45%, and no evidence of pulmonary hypertension\n  * Hepatic: Total bilirubin within normal institutional limits (exception permitted in Gilbert's Syndrome after discussion with study PI, on a case-by-case basis); and AST (SGOT)\u002FALT (SGPT) \\\u003C2x institutional upper limit of normal\n  * Renal: Serum Creatinine within normal institutional limits or creatinine clearance \\>50 mL\u002Fmin\u002F1.73 m2 (see Appendix B) for participants with creatinine levels above institutional normal.\n* The effects of IS-free haploHCT on the developing human fetus are unknown. For this reason and because radiation and chemotherapeutic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and a minimum of 4 months after completion of study.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had cytotoxic chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or mitomycin C) prior to entering the study. Use of hydroxyurea, HMA, e.g., azacytidine, decitabine) and\u002For FDA-approved novel targeted agents (e.g., venetoclax, FLT-3 inhibitors, IDH 1\u002F2 inhibitors) are permitted up to a day prior to start of HCT conditioning.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual non-hematologic toxicities \\> Grade 1) with exception of alopecia, unless cleared by study PI.\n* Participants who received Mylotarg or other therapies associated with increased risk of hepatic veno-occlusive disease (VOD) or have known prior or active VOD. All novel therapies will be reviewed with PI.\n* Participants who are receiving any other investigational agents within 21 days (or 5 half-lives) prior to study entry, whichever is longer, unless cleared by the study PI.\n* Participants with extramedullary disease at immune privileged sites (e.g., CNS, testes, eye) are excluded, as these sites are less susceptible to the curative graft vs. leukemia effect of HCT.\n* Myocardial infarction within 2 years prior to enrollment.\n* Venous thromboembolic event (VTE) of DVT\u002F PE within 1 year prior to enrollment, unless approved by study PI. Patients with line-associated DVT within the past year may be enrolled if they have completed anticoagulation therapy.\n* Stroke or transient ischemic attack (TIA) within 1 year prior to enrollment.\n* History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation or clinically significant gastrointestinal (GI) hemorrhage or hemoptysis within the prior 6 months.\n* Patients with a history of thrombotic microangiopathy (TMA) or hemolytic uremic syndrome\u002Fthrombotic thrombocytopenic purpura (HUS\u002FTTP).\n* History of life-threatening reactions to iron infusions or murine antibody-containing products.\n* Known donor-specific antibodies (DSA) in the recipient of clinical significance (e.g., requiring DSA depletion with plasmapheresis, rituximab) are excluded.\n* Inability to withhold agents that may interact with hepatic cytochrome P450 enzymes involved in cyclophosphamide and\u002For thiotepa metabolism (see Section 5.5) during day -10 through day -5. It is acceptable use alternative non-interacting medications during this period, and then restart prior medications\n* Participants with uncontrolled bacterial, viral or fungal infections (i.e., currently taking medications with progression of clinical symptoms or signs).\n* Recipients of prior allogeneic or autologous hematopoietic cell transplantation, or solid organ transplantation.\n* Prior radiation exposure or other medical condition (e.g., Fanconi syndrome) that precludes use of myeloablative radiation (TMLI).\n* HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the multiple agents used routinely in myeloablative allogeneic stem cell transplantation. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.\n* Participants seropositive for hepatitis B or C infection are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after myeloablative HCT.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because radiation and conditioning chemotherapy has the potential for teratogenic or abortifacient effects. A negative pregnancy test is required for females of childbearing potential. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IS-free haploHCT breastfeeding should be discontinued if the mother is treated with IS-free haploHCT.\n* Participants with a history of another non-hematologic malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.",{"count":205,"type":20},[23],"This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed\u002Frefractory and Ultra-high risk acute myeloid leukemia (AML) and\u002For myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT).\n\nThe names of the study interventions involved in this study are:\n\n* Radiation-Total Myeloid and Lymphoid Irradiation (TMLI)\n* Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna)\n* Infusion of haplo Treg-enriched donor cells (experimental therapy)\n* Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells)\n* Infusion of haplo donor CD34+ Peripheral Blood Stem Cells",[442,60,443,444,445],"Stem Cell Transplant Complications","Myeloid Leukemia, Acute","Myeloid Leukemia in Relapse (Disorder)","Myelodysplastic Syndromes",[442,60,443,444,445],"2025-10-16",{"date":449,"type":38},"2025-10-20",{"date":451,"type":38},"2021-01-12",{"date":453,"type":20},"2029-08-31",{"name":380,"class":76},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":122,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":463,"targetDuration":465,"studyType":127,"phases":4,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":295,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":4},"100609106","hcmv-mirna-monitoring-after-allogeneic-hematopoietic-stem-cell-transplantation-using-pstm-qpcr-100609106","NCT07210242","HCMV-miRNA Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation Using PSTM-qPCR","Clinical Study on Monitoring Cytomegalovirus (HCMV) Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Using High-Performance miRNA Quantification Technology (PSTM-qPCR)","HSCT-HCMV01","Inclusion Criteria:\n\n\\- Patients scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nStem cell source includes peripheral blood stem cells and\u002For bone marrow plus peripheral blood.\n\nAbility to understand study procedures and provide written informed consent.\n\nVoluntary participation in the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n\nChildren or individuals with severe cognitive impairment who cannot comply with blood sample collection.\n\nPatients with severe comorbidities or other medical conditions judged by the investigator to significantly interfere with study participation or follow-up.\n\nWithdrawal of informed consent during the study.\n\nClinical background or history that may introduce significant confounding effects, or when additional sampling frequency is deemed to pose undue risk to the participant.",{"count":464,"type":20},300,"12 Months","Human cytomegalovirus (HCMV) infection is one of the most common and serious complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Standard monitoring uses HCMV DNA testing, but this method may not detect the virus early enough to guide timely treatment.\n\nThis multicenter observational study will evaluate a new high-performance microRNA (miRNA) detection technology (PSTM-qPCR) for monitoring HCMV infection in allo-HSCT patients. Approximately 300 patients and their donors will be enrolled across several major transplant centers in China. Blood samples will be collected before and after transplantation to test for both HCMV-miRNA and HCMV-DNA. The study will compare the sensitivity and timing of miRNA detection with conventional DNA testing and explore whether miRNA can serve as an early biomarker of infection and related complications.\n\nThe goal is to improve early diagnosis and management of HCMV infection, reduce infection-related complications, and ultimately improve survival outcomes in patients undergoing allo-HSCT.",[157,159,468,27],"Virus Reactivation",[470,471,472,473,474,475,476,477,478,320],"Allogeneic Hematopoietic Stem Cell Transplantation","Human Cytomegalovirus","MicroRNA","HCMV-miRNA","PSTM-qPCR","Viral Reactivation","Infection Monitoring","Early Diagnosis","Biomarker","2025-09-29",{"date":481,"type":38},"2025-10-07",{"date":483,"type":20},"2025-10-10",{"date":485,"type":20},"2028-10-10",{"name":487,"class":76},"Ting YANG",{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":15,"minAge":85,"maxAge":388,"enrollmentInfo":496,"targetDuration":4,"studyType":21,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":144},"100607153","ruxolitinib-plus-etanercept-vs-ruxolitinib-for-steroid-refractory-severe-acute-gvhd-100607153","NCT07184853","Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD","Prospective Multicenter Randomized Study of Ruxolitinib Plus Etanercept vs Ruxolitinib Alone for Corticosteroid-Refractory Severe Acute GVHD After Allogeneic HSCT","RESCUE","Inclusion Criteria:\n\nReceived allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source (matched sibling, matched unrelated, or haploidentical), using bone marrow, peripheral blood stem cells, or cord blood; conditioning regimen may be myeloablative, reduced-intensity, or non-myeloablative.\n\nAge between 12 and 70 years.\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n\nClinical diagnosis of grade III-IV acute graft-versus-host disease (aGVHD) according to MAGIC criteria.\n\nEvidence of neutrophil and platelet engraftment prior to study treatment (absolute neutrophil count \\>1,000\u002Fmm³ and platelet count ≥20,000\u002Fmm³ within 48 hours before study entry; growth factor support and transfusion permitted).\n\nDiagnosis of steroid-refractory aGVHD, defined as one of the following:\n\nDisease progression after 3-5 days of methylprednisolone 2 mg\u002Fkg\u002Fday (or equivalent).\n\nNo improvement after 7 days of methylprednisolone 2 mg\u002Fkg\u002Fday (or equivalent).\n\nProgression from grade II to grade III-IV aGVHD after 3-5 days of methylprednisolone 1 mg\u002Fkg\u002Fday (or equivalent).\n\nAble to take oral medication.\n\nExpected survival \\>8 weeks.\n\nWomen of childbearing potential must have a negative serum β-HCG test prior to enrollment; both male and female participants of reproductive potential must agree to use effective contraception during the study and for 3 months after study completion.\n\nVoluntary written informed consent provided and ability to comply with study procedures.\n\nExclusion Criteria:\n\nPrior systemic treatment for aGVHD other than corticosteroids with or without calcineurin inhibitors (CNI); prophylactic use of MTX, MMF, or CD25 monoclonal antibody is permitted.\n\nClinical features consistent with de novo chronic GVHD or overlap syndrome (per Jagasia 2015).\n\nUncontrolled active infection, including severe bacterial, fungal, viral, or parasitic infection. Patients on appropriate treatment without evidence of progression may be eligible.\n\nEvidence of active tuberculosis.\n\nKnown HIV infection.\n\nRelapse of primary malignancy or post-transplant lymphoproliferative disorder.\n\nSevere respiratory disease, including mechanical ventilation or resting oxygen saturation \\\u003C90%.\n\nRenal dysfunction: serum creatinine \\>2.0 mg\u002FdL, requirement for dialysis, or creatinine clearance \\\u003C30 mL\u002Fmin (Cockcroft-Gault).\n\nActive hepatitis B infection (HBsAg positive with HBV DNA ≥1×10³ IU\u002FmL) or active hepatitis C infection (HCV antibody positive with detectable HCV RNA above normal).\n\nClinically significant or uncontrolled cardiac disease, including recent myocardial infarction, uncontrolled hypertension, NYHA class III\u002FIV heart failure, unstable angina, or clinically significant arrhythmia (e.g., sustained ventricular tachycardia, second- or third-degree AV block).\n\nCholestatic disease or unresolved hepatic veno-occlusive disease not attributed to aGVHD.\n\nHistory of progressive multifocal leukoencephalopathy (PML).\n\nPrior exposure to JAK inhibitors after allo-HSCT.\n\nParticipation in another investigational drug trial within 30 days or within 5 half-lives of the investigational drug (whichever is longer).\n\nPrior history of grade ≥3 non-hematologic adverse events attributable to ruxolitinib or etanercept.\n\nAny condition judged by the investigator to place the patient at undue risk or interfere with study participation.\n\nKnown hypersensitivity or intolerance to systemic immunosuppressive agents.\n\nPregnant or breastfeeding women.",{"count":497,"type":20},122,[342],"This is a prospective, multicenter, randomized controlled trial designed to evaluate whether the combination of ruxolitinib and etanercept provides superior efficacy compared with ruxolitinib monotherapy in patients with severe corticosteroid-refractory acute graft-versus-host disease (SR-aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nAcute graft-versus-host disease (aGVHD) is one of the most common and life-threatening complications following allo-HSCT. Although corticosteroids remain the standard first-line treatment, many patients do not respond adequately. For patients with severe steroid-refractory aGVHD, the prognosis is extremely poor, with high short-term mortality and very low long-term survival.\n\nRuxolitinib, a JAK1\u002F2 inhibitor, has been approved for the treatment of SR-aGVHD, but response rates remain suboptimal, particularly in patients with gastrointestinal involvement. Etanercept, a tumor necrosis factor-alpha (TNF-α) inhibitor, has shown activity in GVHD by targeting inflammatory pathways. Previous observational studies from our center suggested that combining ruxolitinib with etanercept may improve response rates, especially in gastrointestinal and hepatic GVHD, without significantly increasing relapse risk.\n\nIn this trial, approximately 122 patients with grade III-IV SR-aGVHD will be randomized 1:1 to receive either ruxolitinib alone or ruxolitinib plus etanercept. The primary endpoint is the overall response rate (ORR) at day 28. Secondary endpoints include durable response, best overall response, failure-free survival, overall survival, cumulative incidence of relapse, non-relapse mortality, incidence of chronic GVHD, and safety outcomes.\n\nThis study seeks to provide new clinical evidence for an optimized treatment strategy for patients with severe SR-aGVHD, aiming to improve outcomes in this high-risk population.",[27],[502,503,504,505,506,507,508,509,510],"Ruxolitinib","Etanercept","JAK1\u002F2 inhibitor","TNF-α inhibitor","Corticosteroid-refractory GVHD","Severe aGVHD","Allo-HSCT complications","Graft-versus-Host Disease treatment","Immunosuppression","2025-09-19",{"date":513,"type":38},"2025-09-22",{"date":515,"type":20},"2025-09-25",{"date":517,"type":20},"2028-09-25",{"name":519,"class":76},"First Affiliated Hospital of Zhejiang University",{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":21,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":543},"100550734","phase-2-vitamin-a-supplementation-in-allogeneic-stem-cell-transplantation-100550734","NCT06450925","Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.","A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.","Inclusion Criteria:\n\n* Be 18 years of age or older\n* Be scheduled for allogeneic stem cell transplant.\n* Have a vitamin A level \\\u003C upper limit of normal for age.\n* Be able to tolerate enteral vitamin dose administration.\n* Have a total bilirubin level \\\u003C 1.5x ULN and an AST and\u002For ALT\\\u003C 3xULN for age\n* Receiving PBSCs as stem cell graft\n\nExclusion Criteria:\n\n* Ongoing raised intracranial pressure\n* Liver cirrhosis\n* Patients will be excluded if they are currently pregnant.",{"count":528,"type":20},190,[24],"The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.",[60,532,533],"Vitamin A Deficiency","Vitamin D Deficiency","2025-08-11",{"date":536,"type":38},"2025-08-12",{"date":538,"type":38},"2025-03-25",{"date":540,"type":20},"2029-08",{"name":542,"class":76},"Children's Hospital Medical Center, Cincinnati",3,{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":21,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":144},"100568491","phase-1-a-phase-i-ii-study-of-high-dose-post-transplant-cyclophosphamide-bortezomib-and-abatacept-for-the-prevention-of-graft-versus-host-disease-gvhd-following-allogeneic-hematopoietic-stem-cell-transplantation-hsct-100568491","NCT06681922","A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n* Age ≥18 years\n* Karnofsky score ≥70%\n* No evidence of progressive bacterial, viral, or fungal infection\n* Creatinine clearance \\>50 mL\u002Fmin\u002F1.72m2\n* ALT and AST \\\u003C3 x the upper limit of normal\n* Total bilirubin \\\u003C2 x the upper limit of normal (except for Gilbert's syndrome)\n* ALP ≤250 IU\u002FL\n* LVEF \\>45%\n* Adjusted DLCO \\>50%\n* Negative HIV serology\n* Negative pregnancy test: Confirmation per negative serum β-hCG\n* Willing to comply with all study procedures and be available for the duration of the study.\n\nExclusion Criteria:\n\n* Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice effective methods of contraception from start of conditioning through 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 consecutive months.\n* Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized.\n* Inability to provide informed consent.\n* Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.\n* Known allergies to any of the components of the investigational treatment regimen.\n* Serious medical or psychiatric illness is likely to interfere with participation in this clinical study.\n* Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy.\n* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.\n* Prisoners\n* Pregnant women",{"count":551,"type":20},10,[23,24],"The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants.",[60],"2024-12-10",{"date":557,"type":38},"2024-12-16",{"date":559,"type":38},"2024-09-23",{"date":561,"type":20},"2027-10",{"name":563,"class":76},"Northwell Health",{"id":565,"slug":566,"hasResults":11,"nctId":567,"briefTitle":568,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":21,"phases":574,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":144},"100464874","morphee--mechanisms-of-cell-death-induced-by-extracorporeal-photochemotherapy-100464874","NCT05333367","MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy","MORPHEE","Inclusion Criteria:\n\n* Adult patients\n* Treated with ECP for at least 1 month, for control of GVHD in hematopoietic cell allograft (acute or chronic GVHD), treatment and control of cellular or humoral rejection in solid organ transplantation (heart, lung, kidney) or in the treatment of cutaneous T-cell lymphoma\n\nExclusion Criteria:\n\n* Subjects with limited legal capacity.\n* Subjects judged by the investigator to be unlikely to comply with study procedures\n* Subjects with no social security coverage.\n* Pregnant women.\n* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.","85 Years",{"count":573,"type":20},20,[342],"The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.",[577,60,131],"Cutaneous T-Cell Lymphoma",[579,580],"Cell death","Extracorporeal Photochemotherapy","2024-11-19",{"date":583,"type":38},"2024-11-21",{"date":585,"type":38},"2022-04-15",{"date":587,"type":20},"2025-07",{"name":589,"class":76},"Centre Hospitalier Universitaire de Besancon",{"id":591,"slug":592,"hasResults":11,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":11,"sex":15,"minAge":597,"maxAge":388,"enrollmentInfo":598,"targetDuration":4,"studyType":21,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":144},"100559760","phase-1-chimeric-natural-killer-receptor-universal-t-cells-for-refractory-gvhd-100559760","NCT06568328","Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD","A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CNK-UT Cells to Treat the Patients With Steroid-refractory\u002FResistant or Steroid-dependent GVHD","Inclusion Criteria:\n\n1. Aged 1\\~70 years, male or female;\n2. Participants diagnosed with grade II\\~IV steroid-refractory\u002Fresistant or steroid-dependent GVHD after allogeneic hematopoietic stem cell transplantation who have failed treatment with ruxolitinib or at least one other second-line medication, or who are intolerant to these medications.\n3. ECOG physical status score 0\\~3;\n4. Estimated life expectancy \\> 12 weeks;\n5. Female participants of childbearing age must undergo a serum or urine pregnancy test before enrollment, and the results must be negative, and agree to take acceptable measures to minimize the possibility of pregnancy during the trial; For female participants of childbearing age or male participants whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the study and for at least 6 months following the last dose of the study cells infusion.\n6. Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.\n\nExclusion Criteria:\n\n1. Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and \u002F or radical resection of carcinoma in situ.\n2. Participants with a history of organ transplantation;\n3. Participants who have previously undergone more than one allogeneic hematopoietic stem cell transplantation.\n4. Uncontrolled hypertension as determined by principal investigator, a history of hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart failure (New York Heart Association classification III-IV); symptomatic or poorly controlled arrhythmias; a history of congenital long QT syndrome or a corrected QT interval (QTc) \\> 500 ms at screening (calculated using the Fridericia method)..\n5. Systemic diseases deemed unstable by principal investigator include, but are not limited to, severe pulmonary, hepatic, renal, or metabolic disorders that require pharmacological intervention (excluding complications related to allogeneic hematopoietic stem cell transplantation).\n6. Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis infection.\n7. Severe infections that are active or poorly controlled clinically.\n8. Participants who have received treatment from other clinical trials within 12 weeks prior to the initiation of the study.\n9. Participants who have previously used any gene therapy products prior to the initiation of the study.\n10. Allergic to components of CNK-UT injection.\n11. Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.\n12. Women who are pregnant or breastfeeding, as well as male or female participants who have planned for birth within 1 year after receiving medication.\n13. Uncontrolled\u002Funcorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and\u002For uncertainty in survival assessments.\n14. Other situations that the participant is identified by the investigator as unsuitable to participate in the study.","1 Year",{"count":599,"type":20},17,[23],"This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory\u002Fresistant or steroid-dependent GVHD.",[27],[604,605],"Chimeric natural killer receptor universal T-cells","steroid-refractory\u002Fresistant or steroid-dependent GVHD","2024-08-22",{"date":608,"type":38},"2024-08-23",{"date":610,"type":20},"2024-09-01",{"date":612,"type":20},"2026-08-31",{"name":614,"class":76},"Fujian Medical University",{"id":616,"slug":617,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":122,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":622,"targetDuration":624,"studyType":127,"phases":4,"briefSummary":625,"conditions":626,"keywords":629,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":144},"100452349","ogvhd-after-bone-marrow-transplantation-a-territory-wide-cohort-100452349","NCT05170347","oGVHD After Bone Marrow Transplantation: a Territory-wide Cohort","Ocular Graft-Versus-Host-Disease After Allogeneic Haematopoietic Stem Cell Transplantation: A Territory-Wide Prospective Cohort","Inclusion Criteria:\n\n* Patient aged 18 or above\n* Underwent allogeneic HSCT in QMH in the two-year recruitment period\n\nExclusion Criteria:\n\n* Underwent autologous HSCT\n* Patient unable to attend follow-up visits\n\nFamily Control Subjects The research team will invite an accompanying family member to be the family control. Microbiome and tear samples will be collected for comparison. The sample collection schedule is the same as the corresponding post-HSCT case.",{"count":623,"type":20},500,"5 Years","Allogeneic Haematopoietic stem cell transplantation (HSCT) is an effective treatment for all array of blood or blood-producing organ disorders. Graft-versus-host-disease (GVHD) occurs as a result of an overactive immunological system against normal host tissues. It can happen in the liver, skin, mucosal surface of the eye, gastrointestinal tract, and genitalia.\n\nOcular GVHD occurs in 30-70% of patients after HSCT. It mainly affects the ocular surface, including the conjunctiva and cornea. In severe cases, multiple clinical manifestations can lead to painful non-healing corneal ulcers, secondary infections, and visual loss.\n\noGVHD can be debilitating and severely impact patients' quality of life. However, there are no widely accepted guidelines available for prevention and management.\n\nIn collaboration with the Department of Haematology of Queen Mary Hospital, the investigators set out to establish a territory-wide cohort of patients receiving HSCT. Primarily, the investigators aim to establish the population-based epidemiology of oGVHD and understand the natural history and the long-term ophthalmic outcomes of oGVHD via this study.",[60,627,628],"Haematological Malignancy","Cancer",[60,630,628,631],"Bone Marrow Transplant","Haematological malignancy","2021-12-09",{"date":634,"type":38},"2021-12-27",{"date":636,"type":38},"2021-04-30",{"date":638,"type":20},"2028-10",{"name":640,"class":76},"The University of Hong Kong"]