[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gvhd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gvhd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,74,108,133,165,189,220,253,297,321],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100592599","phase-2-vorinostat-for-graft-versus-host-disease-gvhd-prevention-in-non-malignant-adolescent-and-young-adults-aya-population-100592599",false,"NCT06995521","Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population","Use of Vorinostat as GVHD Prophylaxis in Children, Adolescents, and Young Adults With Non-Malignant Disorders Undergoing Allogeneic Blood and Marrow Transplantation","Inclusion Criteria:\n\n* Non-malignant condition amenable to transplantation, including but not limited to:\n\n  1. Primary Immunodeficiency\u002FPrimary Immune regulatory disorders\n  2. Inborn errors of metabolism\n  3. Red blood cell disorders including hemoglobinopathies per protocol.\n  4. Inherited bone marrow failure syndromes\n* Available donor per protocol (matched siblings and matched unrelated donors, haploidentical donors). The use of mismatched unrelated donors will not be allowed for this study.\n* Patient and\u002For legal guardian have signed the informed consent document\n* Adequate organ function and performance status for allogeneic hematopoietic stem cell transplantation as defined by institutional practice:\n\n  1. Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in the first second (FEV1), Forced vital capacity (FVC) ≥50% predicted.\n  2. Renal Function: Estimated or actual glomerular filtration rate (GFR) of ≥50 milliliters per minute (mL\u002Fmin)\u002F1.72 square meter (m2)\n  3. Liver Function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\\u003C3x upper limit of normal; total bilirubin ≤2.5 milligrams per deciliter (mg\u002FdL) unless related to disease or Gilbert syndrome. There is no upper limit for bilirubin in patients with confirmed Gilbert syndrome.\n  4. Cardiac Function: Ejection fraction (EF) ≥50% or fractional shortening (FS) ≥26%\n  5. Performance Status: Karnofsky\u002FLansky score ≥70%(HIV) and Human T-lymphotropic virus type (HTLV) I\u002FII negative\n  6. Infectious Disease testing: human immunodeficiency virus\n* Patients with transfusion-dependent anemias (per protocol) should have a liver MRI to document hepatic iron content (certain values will be excluded)\n* All patients of childbearing age must agree to practice 2 effective methods of contraception at the same time or agree to abstinence for 6 months after the last dose for females. Males with female sexual partners of reproductive potential should use contraception during treatment and for at least 3 months after the last dose.\n* Patients treated with other investigational therapies for underlying disorder must discontinue these therapies prior to enrollment on the study unless, in the opinion of the treating physician, discontinuing these therapies prior to transplant would place the patient at undue risk of morbidity or mortality. In this case, patients must discontinue investigational therapies prior to initiation of the conditioning regimen.\n\nExclusion Criteria:\n\n\\- Previous diagnosis of Fanconi anemia, dyskeratosis congenita or other telomere biology disorders, inherited genetic conditions known to adversely affect DNA-repair, or other disorders with known chemo- or radiosensitivity.\n\nAdditional testing may be conducted per investigator discretion but is not required for enrollment.\n\n* Diagnosis of idiopathic severe aplastic anemia\n* Diagnosis of severe combined immunodeficiency syndrome\n* Diagnosis of malignancy within the last 5 years.\n* Diagnosis of Epstein-Barr virus (EBV)-driven lymphoproliferative disorder within the last 5 years\n* Uncontrolled bacterial, viral, or fungal infection at the time of enrollment\n* Seropositive for HIV or HTLV\n* Active hepatitis B or C\n* Female patients that are pregnant or breast-feeding\n* Inability to take oral medications.\n* History of allergy to Vorinostat, related compounds, or any drugs used as part of the conditioning regimen or GVHD prophylaxis.\n* Patients with transfusion-dependent anemia (≥8 packed red blood cell (PRBC) transfusions\u002Fyear or ≥20 lifetime transfusions) that have a liver iron content of \\>8 milligram (mg) Iron(Fe)\u002FGram dry weight or evidence of bridging fibrosis or cirrhosis on biopsy.\n* Patients enrolled on another GVHD-prevention clinical trial.\n* Patients receiving an ex-vivo T cell-depleted or cluster of differentiation (CD34)-selected stem cell graft.\n* Subjects that have had prior treatment with a histone deacetylase inhibitor (e.g. vorinostat, valproic acid) within the last 30 days.\n* History of prolonged corrected QT interval (QTc) syndrome.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","ALL","1 Year","26 Years",{"count":20,"type":21},55,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm, open label, phase 2 study to determine the safety and efficacy of vorinostat without serotherapy as GVHD prophylaxis when combined with either tacrolimus and methotrexate or post-transplant cyclophosphamide, tacrolimus, and mycophenolate in patients aged 1 to 26 years of age with non-malignant disorders undergoing bone marrow transplant following myeloablative conditioning.",[27],"GVHD",[29,30],"Non-malignant condition","Medication Vorinostat","NOT_YET_RECRUITING","2026-06-26",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":21},"2026-07",{"date":39,"type":21},"2028-06",{"name":41,"class":42},"Sung Won Choi","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100491192","phase-2-a-study-of-photobiomodulation-pbm-therapy-in-people-with-oral-graft-versus-host-disease-gvhd-after-stem-cell-transplant-100491192","NCT05675930","A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant","A Multi-Center, Phase II, Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Photobiomodulation for the Treatment of Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation (the LIGHT Trial)","Inclusion Criteria:\n\n* Allo-HCT recipients\n* Age ≥ 4 years-old\n* Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy, including topical corticosteroids..\n* No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment.\n* If a patient is currently using another oral topical treatment for mouth lesions\u002Fsymptoms, patient must be stable on this treatment for ≥2 weeks prior to study enrollment. Patient may continue same topical dose\u002Ffrequency during the study period.\n\nExclusion Criteria:\n\n* Presence of an active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.\n* Personal history of mucosal head and neck cancer in the past 5 years.\n* Pregnant or breastfeeding.\n* The subject or guardian is unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests.\n* Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.","4 Years",{"count":53,"type":21},44,[24],"The purpose of this study is to find out whether photobiomodulation\u002FPBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease\u002FGVHD.",[57,27,58],"Graft-Versus-Host Disease","Undefined",[57,27,60,61,62,63],"Chronic Graft Versus Host Disease Oral","PhotobiomoduLatIon","Memorial Sloan Kettering Cancer Center","22-271","RECRUITING","2026-05-20",{"date":67,"type":35},"2026-05-22",{"date":69,"type":35},"2022-12-22",{"date":71,"type":21},"2026-12-22",{"name":62,"class":42},9,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":43},"100636801","quantification-of-peripheral-blood-inkts-after-allogeneic-stem-cell-transplantation-100636801","NCT07570407","Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation","Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.","QiNKT-HSCT","Inclusion Criteria:\n\n* Diagnosis: AML (exlusion of secondary disease)\n* Disease status at time of HSCT: complete remission\n* Karnofsky performance status: ≥80%\n* Source of HSC: PBSC\n\nExclusion Criteria:\n\n* Prior transplant\n* Uncontrolled Malignancy","18 Years","70 Years",{"count":85,"type":21},75,"OBSERVATIONAL","The transplantation of allogeneic haematopoietic stem cells (HSCs) can lead to serious complications after transplantation, such as graft-versus-host disease (GvHD), infections and relapse due to immunosuppression. Invariant NKT cells (iNKT cells) play a pivotal role in modulating the immune response and have been demonstrated to be instrumental in the pathogenesis of GvHD, cytomegalovirus (CMV) infection, and relapse. Their levels are associated with the development of these complications. This multicentre study aims to test the feasibility of standardising iNKT cell monitoring and to investigate the association between iNKT cell levels and post-transplant complications.",[89,90,91,92,93],"Allogeneic HSCT","Posttransplant Complications","GvHD","Relapse","Acute Myeloid Leukemia",[95,96,97,98],"iNKT cells","HSCT","Flow cytometry","Reconsitution","2026-04-29",{"date":101,"type":35},"2026-05-06",{"date":103,"type":21},"2026-05-01",{"date":105,"type":21},"2029-01-31",{"name":107,"class":42},"University Hospital Pilsen",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":116,"maxAge":83,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100522477","phase-3-phase-iii-study-comparing-gvhd-prophylaxis-with-atg-thymoglobulin-to-atlg-grafalon-in-elderly-patients-with-acute-myeloid-leukemia-or-myelodysplasic-syndrome-and-receiving-an-allogeneic-hematopoietic-stem-cell-transplantation-with-a-1010-hla-matched-unrelated-donor-100522477","NCT06083129","Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10\u002F10 HLA Matched Unrelated Donor","Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10\u002F10 HLA Matched Unrelated Donor Following a Reduced Intensity Conditioning Regimen by Fludarabine-treosulfan","OPTISAGE","Inclusion Criteria:\n\n1. Age ≥ 50 and ≤ 70 years\n2. Patient between 50 and 55 years should be unfit for a myeloblative conditioning (SORROR score ≥2)\n3. AML requiring allogeneic stem cell transplantation (intermediate or high-risk AML) in complete cytologic response (CR1 or above) or MDS requiring allogeneic stem cell transplantation (IPSS≥ 1.5 or IPSS-R \\> 4.5 or IPSS-R \\> 3-4.5 with risk features \\[rapide blast increase, life-threatening neutropenia (\\\u003C0.3 G\u002FL) or thrombopenia (\\\u003C30G\u002FL) or high transfusion needs (\\>2\u002Fmonth for 6 months)\\]\n4. Without an HLA matched related donor\n5. Having an identified matched HLA 10\u002F10 unrelated donor\n6. With usual criteria for HSCT:\n\n   1. ECOG performans status ≤ 2\n   2. No severe and uncontrolled infection\n   3. Cardiac left ventricular ejection fraction ≥50%\n   4. Lung DLCO \\> 40%\n   5. Adequate organ function: ASAT and ALAT ≤ 3N, total bilirubin ≤ 2N, creatinine clearance ≥ 50 mL\u002Fmin (except if those abnormalities are linked to the hematological disease)\n7. With health insurance coverage\n8. Having signed a written informed consent\n9. Contraception methods must be prescribed during all the duration of the research\n\nNB: The authorized contraceptive methods are:\n\n* For women of childbearing age and in absence of permanent sterilization: oral, intravaginal or transdermal combined hormonal contraception, oral, injectable or transdermal progestogen-only hormonal contraception, intrauterine hormonal releasing system (IUS), sexual abstinence (only if this the preferred and usual lifestyle of the participants).\n* For man in absence of permanent sterilization: sexual abstinence, condoms\n\nExclusion Criteria:\n\n1. Cancer in the last 5 years (except basal cell carcinoma of the skin or \"in situ\" carcinoma of the cervix)\n2. Uncontrolled infection\n3. Seropositivity for HIV or HTLV-1 or active hepatitis B or C\n4. Yellow fever vaccine and all others live virus vaccines within 2 months before transplantation\n5. Heart failure according to NYHA (II or more) or Left ventricular ejection fraction \\\u003C 50%.\n6. Lung DLCO ≤ 40%\n7. Preexisting acute hemorrhagic cystitis\n8. Renal failure with creatinine clearance \\\u003C 50ml \u002F min\n9. Pregnancy (β-HCG positive) or breast-feeding\n10. Patients with any debilitating medical or psychiatric illness, which would preclude the realization of the SCT or the understanding of the protocol\n11. Patient under state medical aid\n12. Patient under legal protection (protection of the court, or in curatorship or guardianship).\n13. For Grafalon: Hypersensitivity to the active substance or to any of the excipients\n14. For Thymoglobulin: Hypersensitivity to rabbit proteins or to any of the excipients\n15. Participation in other interventional clinical trials\n16. Any contraindication mentioned in the SmPC of all auxiliary medicinal products planned to be used in the trial: cyclosporine, mycophenolate mofetil, fludarabine, treosulfan","50 Years",{"count":118,"type":21},324,[120],"PHASE3","Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Most of the patients requiring an allo-HSCT are above 50 years of age and are transplanted with a reduced intensity conditioning (RIC) regimen. The optimal RIC and Graft Versus Host Disease (GVHD) prophylaxis regimen allowing a good control of the disease while preventing GVHD remains to be determined for elderly patients. A phase III trial comparing the conventional RIC fludarabine-busulfan 2 days to fludarabine-treosulfan demonstrated an advantage for the flu-treosulfan arm in terms of event free survival (EFS), that should therefore be considered as the new standard of RIC regimen for AML and MDS. GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia (GVL) effect and immune reconstitution. Anti-thymocyte globulins (ATG) are recommended to reduce the risk of acute and chronic GVHD in transplants performed with matched unrelated donors. However, the optimal type of ATG between the 2 approved brands (ATG-thymoglobulin and ATLG-grafalon) displaying distinct characteristics and the optimal dose of ATG are still unknown. In a retrospective study of patients transplanted mainly with RIC with matched related and unrelated donors for haematological malignancies, Anti-T lymphocyte globulin (ATLG) was associated with a reduction of grade II-IV acute GVHD in comparison to ATG without increasing the incidence of relapse.\n\nThis phase III randomised study propose to compare GVHD prevention with ATG versus ATLG in AML and MDS patients above 50 years of age transplanted with a matched unrelated donor following a fludarabine-treosulfan RIC, with the hypothesis that ATLG would better control GVHD in this population of patients thus limiting the risk of morbidity and mortality of the procedure.",[27],"2026-04-22",{"date":125,"type":35},"2026-04-27",{"date":127,"type":35},"2023-11-28",{"date":129,"type":21},"2028-11-28",{"name":131,"class":42},"Assistance Publique - Hôpitaux de Paris",28,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":153,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":43},"100616220","phase-1-tacrolimus-targeted-immunosuppression-cessation-in-allogeneic-hct-100616220","NCT07302776","TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","Inclusion Criteria:\n\n* Eligible diseases:\n\n  * Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.\n  * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy\n  * Myelofibrosis (MF)\n  * Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy\n  * Chronic myelomonocytic leukemia (CMML)\n* Age ≥ 18 and ≤ 80 years at the time of enrollment.\n* Planned for first myeloablative or reduced intensity allogenic transplant using a conditioning regimen listed in Appendix B.\n* Has a related or unrelated donor available who is 8\u002F8 HLA match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n\nCardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n\n* Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n* Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n* Karnofsky Performance Score ≥70%\n* Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\nA female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n-Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior allogeneic HCT.\n* Planned donor lymphocyte infusion (DLI).\n* Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n  1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n  2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment including known, active tuberculosis infection.\n* Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n  \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT.\n\nKnown allergy or hypersensitivity to planned GVHD prophylactic medications including PTCy, tacrolimus\n\n* Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n* Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers or other early-stage solid tumors that have been curatively resected or treated to curative intent. Patients with history of low grade concurrent blood cancers that are controlled will be eligible.\n* Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n(FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.\n\n\\* All subject files must include supporting documentation to confirm subject eligibility.","80 Years",{"count":142,"type":21},50,[144],"PHASE1","The purpose of this study is to test the feasibility and safety of early cessation of tacrolimus following allogeneic hematopoietic cell transplantation (HCT). Post-HCT tacrolimus is given to prevent graft-vs-host-disease (GVHD), but with the use of post-transplant cyclophosphamide (PTCy), the modern approach to GVHD prevention, GVHD rates have reduced markedly.",[27,147,148,149,150,151,152],"Hematopoietic Cell Transplantation (HCT)","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes","Myelofibrosis (MF)","Chronic Myeloid Leukemia (CML)","Chronic Myelomonocytic Leukemia (CMML)",[154,155],"Post-Hematopoietic Cell Transplant (HCT) tacrolimus","hematopoietic cell transplantation (HCT)","2026-04-14",{"date":158,"type":35},"2026-04-17",{"date":160,"type":21},"2026-06",{"date":162,"type":21},"2028-02",{"name":164,"class":42},"Stanford University",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":43},"100561447","diagnostic-refinement-and-educational-approaches-in-managing-bone-marrow-transplantation-100561447","NCT06590285","Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation","Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)","DREAM-BMT","Inclusion Criteria:\n\n* Male or female patients aged 18 or older at the time of study informed consent.\n* Have plan to undergo alloHSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative and reduced intensity conditioning are eligible.\n* Patients have access to digital device capable of downloading study app\n* Patients able to read study documents and able to complete informed consent within the study app\n\nExclusion Criteria:\n\n* Failed prior alloHSCT within the past 6 months",{"count":174,"type":21},60,[176],"NA","This randomized, phase I\u002FII, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.",[27,179],"Bone Marrow Transplant Complications","2026-04-03",{"date":182,"type":35},"2026-04-09",{"date":184,"type":35},"2026-04-02",{"date":186,"type":21},"2033-11-01",{"name":188,"class":42},"Scripps Health",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":197,"enrollmentInfo":198,"targetDuration":17,"studyType":86,"phases":4,"briefSummary":200,"conditions":201,"keywords":207,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":43},"100617151","psychiatric-status-and-symptom-severity-in-graft-versus-host-disease-gvhd-100617151","NCT07314892","Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).","Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).","Psych-GvHD","Inclusion Criteria:\n\n* Adult patients with a clinically established diagnosis of graft-versus-host disease (GvHD) receiving specialist follow-up care at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK), Gdańsk.\n\nExclusion Criteria:\n\n* Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.","75 Years",{"count":199,"type":21},200,"This prospective observational study evaluates the association between psychiatric status, GvHD-related symptom severity, and health-related quality of life in patients with graft-versus-host disease. Standardized and validated assessment tools, including the Lee Symptom Scale, will be used to collect psychiatric, clinical, and demographic data.",[202,203,27,204,205,206],"GVHD, Chronic","GVHD - Graft-Versus-Host Disease","Quality of Life","Depression Disorders","Cognitive Impairments",[91,208,209,210],"depression","quality of life","Cognitive impairment","2025-12-18",{"date":213,"type":35},"2026-01-02",{"date":215,"type":35},"2025-04-08",{"date":217,"type":21},"2028-10",{"name":219,"class":42},"Medical University of Gdansk",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":238,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":43},"100594024","phase-2-autologous-serum-obtained-by-a-closed-circuit-collection-device-100594024","NCT07014059","Autologous Serum Obtained by a Closed-Circuit Collection Device","\"In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device.\"","Inclusion Criteria:\n\n* ≥ 18 years\n* Dry eye and\u002For chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;\n* Peripheral venous access or PICC that allows the collection of whole blood.\n\nExclusion Criteria:\n\n* Active ocular infection;\n* Hemoglobin \\\u003C 11 g\u002FdL;\n* Angina, MI, or stroke in the last 30 days;\n* Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;\n* Active ocular or systemic infection at the time of collection;\n* Inability to attend follow-up visits at 6 and 12 weeks;\n* Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);\n* Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;\n* Life expectancy \\\u003C 6 months;\n* Not pregnant (as reported by the participant).",{"count":228,"type":21},16,[24],"Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.",[27,232,233,234,235,236,237],"Meibomian Gland Dysfunction (Disorder)","Stevens-Johnson Syndrome","Limbal Keratoconjunctivitis","Recurrent Erosions of Persistent Epithelial Defects","Neurotrophic Ulcer","Sjogren Syndrome With Keratoconjunctivitis",[239,240,241,232,233,234,236,235,242,243],"soro autologo","gvhd","Sjogren's Syndrome (SS)","Study Protocol - Autologous Serum","Autologous Serum","2025-06-02",{"date":246,"type":35},"2025-06-10",{"date":248,"type":21},"2025-06-20",{"date":250,"type":21},"2027-06-20",{"name":252,"class":42},"GIANCARLO FATOBENE",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":273,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":296},"100551613","phase-1-prevention-of-gvhd-in-participants-with-hematological-malignancies-undergoing-hematopoietic-stem-cell-transplant-hsct-100551613","NCT06462365","Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)","Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n1. Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)\n2. Males and Females Age ≥ 18 years.\n3. Weight of ≥ 35 Kg.\n4. Karnofsky performance status ≥ 70 %.\n5. Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.\n6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.\n7. Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.\n8. Have adequate organ function.\n9. Subjects \\> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \\\u003C 5.\n10. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.\n\nExclusion Criteria:\n\n1. Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.\n2. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.\n3. HIV positive.\n4. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.\n5. Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.\n6. Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and\u002For have not recovered from treatment related toxicities.\n7. Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.\n8. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects must agree to use a highly effective method of contraception).\n9. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.",{"count":261,"type":21},36,[144],"The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.",[265,91,266,202,267,268,269,270,149,271,272],"Hematologic Malignancy","GVHD,Acute","Hematopoietic Stem Cell Transplant","Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, Adult T-Cell","Acute Myeloid Leukemia in Remission","Chronic Myelomonocytic Leukemia, in Remission","Cancer Remission",[274,275,276,277,278,279,280,281,282,283,284,285],"AML","CMML","Stem Cell Transplant","B-ALL","T-ALL","Acute GvHD","Graft versus Host Disease","Chronic GvHD","MDS","Cellular Therapy","Autoimmune","T regulatory cells","2025-04-10",{"date":288,"type":35},"2025-04-15",{"date":290,"type":35},"2024-04-08",{"date":292,"type":21},"2027-04-15",{"name":294,"class":295},"Tr1X, Inc.","INDUSTRY",5,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":4},"100547685","phase-1-safety-and-efficacy-of-treg-cell-in-the-treatment-of-gvhd-100547685","NCT06411184","Safety and Efficacy of Treg Cell in the Treatment of GVHD","Safety and Efficacy of Treg Cell in the Treatment of GVHD After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.\n2. Those with persistent manifestations of graft-versus-host disease (GVHD) and suitable for systemic treatment.\n3. Previously received at least 1 but not more than 5 lines of systemic treatment for GVHD.\n4. Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose \\>0.5mg\u002Fkg\u002Fday for four weeks, with ongoing GVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to \\>0.25mg\u002Fkg\u002Fday or an equivalent dose.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0\\~1.\n6. Anticipated survival of more than 12 months.\n\n   General criteria:\n7. Serum pregnancy test negative for women of childbearing age during the screening period.\n8. Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.\n\nExclusion Criteria:\n\n1. Patients who have received experimental treatment for systemic GVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.\n2. Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening.\n\n   Laboratory tests:\n3. Absolute neutrophil count (ANC) \\\u003C1.5×10\\^9\u002FL (excluding GVHD as the cause).\n4. Platelet count \\\u003C50×10\\^9\u002FL (excluding GVHD as the cause).\n5. Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) \\>3×ULN (excluding GVHD as the cause).\n6. Total bilirubin (TBIL) \\>1.5×ULN (excluding GVHD as the cause).\n7. Creatinine clearance CrCl \\\u003C60 mL\u002Fmin (Cockcroft-Gault formula).\n\n   General criteria:\n8. Pregnant or lactating women.\n9. History of serious illness or other evidence indicating a serious illness, or any other condition that the investigator believes may make the subject unsuitable for this study.\n\n   * History of severe cardiovascular disease \\[New York Heart Association (NYHA) functional class III or IV\\], including but not limited to ventricular arrhythmias requiring clinical intervention, uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002F or diastolic blood pressure ≥100mmHg); within 6 months prior to enrollment, there is unstable angina, acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of class III or above; at screening, NYHA functional class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n   * Unable to take oral medications, with severe (NCI CTCAE v5.0 ≥ grade 3) chronic gastrointestinal dysfunction, the presence of malabsorption syndrome, or any other condition affecting gastrointestinal absorption.\n   * History of clear neurological or psychiatric disorders (including epilepsy or dementia), currently suffering from psychiatric disorders, or judged by the investigator to be non-compliant and unsuitable for participation in the study.\n   * History of other severe (NCI CTCAE v5.0 ≥ grade 3) systemic diseases, deemed unsuitable for participation in the clinical trial by the investigator.\n10. Other circumstances in which the investigator deems it inappropriate to participate in this study.","60 Years",{"count":306,"type":21},20,[144,24],"This is a randomized, single-center phase 1\u002F2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD.",[27],[311,27],"Regulatory T-Lymphocytes","2024-05-07",{"date":314,"type":35},"2024-05-13",{"date":316,"type":21},"2024-06-01",{"date":318,"type":21},"2027-05-31",{"name":320,"class":42},"Xuzhou Medical University",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":328,"maxAge":304,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":43},"100521871","phase-2-map-guided-preemptive-therapy-of-agvhd-by-ruxolitinib-100521871","NCT06075225","MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib","The MAGIC Algorithm Probability Guided Preemption of Steroid-refractory Graft-versus-host Disease With Ruxolitinib","Inclusion Criteria:\n\n* Any donor type (e.g., related, unrelated, haplo) or stem cell source (bone marrow, peripheral blood, cord blood).\n* Any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable.\n* GVHD prophylaxis must include a calcineurin inhibitor combined with post transplant cyclophosphamide.\n* The use of serotherapy to prevent GVHD (e.g., antithymocyte globulin) prior to day 3 post-HCT is permitted\n* Direct bilirubin must be \\\u003C2 mg\u002FdL unless the elevation is known to be due to Gilbert syndrome within 3 days prior to enrollment.\n* ALT\u002FSGPT and AST\u002FSGOT must be \\\u003C5 x the upper limit of the normal range within 3 days prior to enrollment.\n* Signed and dated written informed consent obtained from patient or legal representative.\n\nExclusion Criteria:\n\n* Patients who develop acute GVHD prior to start of study drug\n* Patients at very high risk for relapse post HCT as defined by very high disease risk index\n* Patients participating in a clinical trial where prevention of GVHD is the primary endpoint\n* Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)\n* Patients who are pregnant\n* Patients on dialysis within 7 days of enrollment\n* Patients requiring ventilator support or oxygen supplementation exceeding 40% FiO2 within 14 days of enrollment.\n* Patients receiving investigational agent within 30 days of enrollment. However, the Principal Investigator (PI) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of ruxolitinib","16 Years",{"count":330,"type":21},62,[24],"The goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:\n\n• Effect of MAGIC algorithm probability guided preemption of aGVHD with ruxolitinib on prevention of severe aGVHD.\n\nParticipants will take ruxolitinib with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days.\n\nResearchers will compare patients who don't receive preemption of aGVHD with ruxolitinib to see if there is an improvement in severe aGVHD.",[27,334],"Acute Stem Cell Transplant Complications","2023-10-03",{"date":337,"type":35},"2023-10-10",{"date":339,"type":21},"2023-10-01",{"date":341,"type":21},"2026-09-30",{"name":343,"class":42},"Sichuan University"]