[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gvhdacute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gvhdacute":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,69,97,141],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100494485","cxcl9-and-easix-for-prediction-of-acute-graft-versus-host-disease-100494485",false,"NCT05718791","CXCL9 and EASIX for Prediction of Acute Graft Versus Host Disease","CXC-chemokine Ligand 9 (CXCL9) and Endothelial Activation and Stress Index (EASIX) for Prediction of Acute Graft Versus Host Disease","Inclusion Criteria:\n\n* Patients \\>18 year old admitted for allo SCT PB for malignant disease.","ALL","18 Years","80 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The prediction of severe acute GVHD before it occurs is of high importance for ensuing clinical decisions and overall success of allogeneic SCT. The key immunologic signatures associated with clinical outcomes after different graft versus host disease prophylaxis methods or peripheral blood stem cell transplant are largely unknown.",[25],"GVHD,Acute","RECRUITING","2026-04-29",{"date":29,"type":30},"2026-05-01","ACTUAL",{"date":32,"type":30},"2023-05-10",{"date":34,"type":21},"2027-12-30",{"name":36,"class":37},"Henry Ford Health System","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":38},"100619138","phase-2-novel-first-line-therapies-for-grade-ii-acute-gvhdgraft-versus-host-disease--100619138","NCT07340723","Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )","Novel First-line Therapies for Grade II Acute GVHD: a Randomized Controlled Trial","GVHD","Inclusion Criteria:\n\n1. Diagnosed with hematological diseases.\n2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.\n3. New onset of grade II acute GVHD or intermediate or high risk aGVHD (based on modified GVHD Glucksberg criteria) within 100 days post-transplantation.\n\nExclusion Criteria:\n\n1. Recipients of second allogeneic stem cell transplant.\n2. Acute GVHD induced by donor lymphocyte infusion, interferon.\n3. Received first line aGVHD treatment before enrollment.\n4. Overlap GVHD syndrome.\n5. Pregnant or breast-feeding women.\n6. Pregnant or breast-feeding women.\n7. Serum creatinine \\> 2.0 mg\u002FdL or creatinine clearance \\\u003C 40 mL\u002Fmin measured or calculated by Cockroft-Gault equation.\n8. Uncontrolled infection.\n9. Human immunodeficiency virus infection.\n10. Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.\n11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.\n12. Allergic history to Janus kinase inhibitors.\n13. Severe organ dysfunction unrelated to underlying GVHD, including:\n\n(1)Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).\n\n(2)Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.\n\n(3)Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.\n\n14.Received Janus kinase inhibitor therapy after allo-HSCT for any indication. 15.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.","14 Years",{"count":49,"type":21},168,"INTERVENTIONAL",[52],"PHASE2","The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for grade II acute GVHD (graft-versus-host disease )",[25,55],"Stem Cell Transplant Complications",[57,58,59],"acute graft-versus-host disease","Ruxolitinib","first line therapy","2026-01-05",{"date":62,"type":30},"2026-01-14",{"date":64,"type":30},"2025-06-01",{"date":66,"type":21},"2027-06-01",{"name":68,"class":37},"Daihong Liu",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":50,"phases":79,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":38},"100540320","phase-2-trial-of-2-step-atg-for-acute-gvhd-prevention-post-myeloablative-allogeneic-stem-cell-transplant-100540320","NCT06315309","Trial of 2 Step ATG for Acute GVHD Prevention Post Myeloablative Allogeneic Stem Cell Transplant","Phase II Clinical Trial of 2 Step ATG Combined With Tacrolimus and Mini Methotrexate for Prevention of Acute GVHD Post Myeloablative Allogeneic Stem Cell Transplant","Inclusion Criteria:\n\n1. Adult male or female, age 18-60 years\n2. Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6\u002F6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. Unrelated donor must be 8\u002F8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to NMDP criteria.\n3. A candidate for Myeloablative preparative regimen, based on age ≤ 60, or HCT-CI of ≤ 4, and considered by the treating physician to be a candidate for such regimen.\n4. Cardiac function: Ejection fraction ≥ 45%\n5. Calculated creatinine clearance greater than 50 mL\u002Fminute (using the Cockcroft-Gault formula and actual body weight).\n6. Pulmonary function: DLCO ≥50% (adjusted for hemoglobin) and FEV1≥50%\n7. Liver function: total bilirubin \\\u003C 1.5x the upper limit of normal and ALT\u002FAST \\\u003C 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value up to \\\u003C3mg\u002Fdl.\n8. Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two effective methods of contraception (hormonal contraception and male partner to use condom) or agree to complete abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.\n9. Male subjects (even if surgically sterilized), of partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.\n10. Karnofsky performance status KPS ≥ 80 (Appendix B)\n11. Patients must have a diagnosis of one of the following:\n\n    A-Acute myeloid leukemia (AML) in complete remission CR 1 with intermediate or high risk for relapse as defined by ELN 2022 criteria(Dohner et al., 2022) (appendix C), or deemed to be at high risk for relapse by treating physician, based on, therapy related, or extra medullary presentation.\n\n    B-AML in \\>CR1. C-Myelodysplastic syndrome (MDS) with IPSS-M ≥ intermediate-low.(Bernard et al., 2022; Mohty et al., 2022) D- Chronic myeloproliferative disorder (ET, PV, myelofibrosis) with bone marrow blasts \\> 5% and\u002For other evidence of progression to acute leukemia or Int or high-risk disease by MIPPS v2 score.(Ali et al., 2019; Guglielmelli et al., 2018) E- CMML especially those with high-risk features based in: The CMML-specific prognostic scoring system with molecular features (CPSS-Mol) - high risk and intermediate-2 risk, Mayo molecular model - high risk and Intermediate-2 risk, Groupe Francophone des Myélodysplasies (GFM) - high risk and selected patients with intermediate risk.(Elena et al., 2016; Itzykson et al., 2013; Patnaik et al., 2014). F- Acute lymphoblastic leukemia (ALL) in CR1 with high risk for relapse\n    * B-cell ALL: High white blood cell count at diagnosis (ie, \\>30,000\u002Fµl), Clonalcytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity, BCR-ABL1-like (Ph-like) gene signature, progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22, but not CD10), Length of time from start of induction therapy to attainment of CR greater than four weeks, and minimal residual disease (MRD) post-remission bone marrow MRD+.(Akabane \\& Logan, 2020; Lafage-Pochitaloff et al., 2017)\n    * T-cell ALL: Failure to achieve CR after one induction, MRD\\> 1X 10-4 after 2 courses of induction, Presenting WBC \\> 100 X 109\u002FL, complex cytogenetics ≥5,early T-cell Precursor ALL, poor risk genetics including lack of NOTCH1 ith\u002FFBXW7 or presence of N-RAS \\& K-RAS, EZH2 and age\\>40 years.(Marks \\& Rowntree, 2017) G- ALL in \\>CR1\n12. The subject is willing and able to sign informed consent and abide by the protocol requirements.\n\nExclusion Criteria:\n\n1. Autologous hematopoietic stem cell transplant \\\u003C 3 months prior to enrollment.\n2. Patients with florid residual AML with \\> 5% blast in the marrow or circulating blast in the peripheral blood are not eligible for this study.\n3. Previous allogeneic stem cell transplant.\n4. Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.\n5. Known hypersensitivity to the study agent (ATG)\n6. Received any investigational drugs within the 14 days prior to the first day of transplant conditioning\n7. Pregnant and\u002For breastfeeding\n8. Evidence of HIV infection or known HIV positive serology.\n9. Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).\n10. Non-hematologic malignancy within prior three (3) years, with the exception of squamous cell or basal cell skin carcinoma.\n11. Participation in another clinical study with an investigational product during the last 28 days.","60 Years",{"count":78,"type":21},29,[52],"The purpose of this study is to test whether the combination of the drugs called tacrolimus (Tac), methotrexate (MTX) and new dosing strategy of another drug called (rabbit Anti-thymocyte Globulin \\[ATG\\]) will help prevent the development and\u002For improve severity of acute and\u002For chronic GVHD.",[25,82,83,84],"Acute Leukemia","Myelodysplastic Syndromes","Myeloproliferative Disorders",[86,87,84],"Leukemia","Myelodysplastic Syndrome","2025-10-06",{"date":90,"type":30},"2025-10-08",{"date":92,"type":30},"2025-04-15",{"date":94,"type":21},"2027-05",{"name":96,"class":37},"University of Alabama at Birmingham",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":50,"phases":106,"briefSummary":108,"conditions":109,"keywords":119,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":5},"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":105,"type":21},36,[107],"PHASE1","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.",[110,111,25,112,113,114,115,116,83,117,118],"Hematologic Malignancy","GvHD","GVHD, Chronic","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",[120,121,122,123,124,125,126,127,128,129,130,131],"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":92,"type":30},{"date":135,"type":30},"2024-04-08",{"date":137,"type":21},"2027-04-15",{"name":139,"class":140},"Tr1X, Inc.","INDUSTRY",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":50,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100505005","phase-1-wharton-jelly-mesenchymal-stromal-cells-as-gvhd-prophylaxis-100505005","NCT05855707","Wharton Jelly Mesenchymal Stromal Cells as GVHD Prophylaxis","Wharton's Jelly Mesenchymal Stromal Cell (WG-MSC) Injections as GVHD Prophylaxis in Hematopoietic Allogeneic Stem Cell Transplantation With an Haplo-identical Donor : a Dose Escalation Study","HAPLO-GEL","Inclusion Criteria:\n\n* With AML\u002FALL\u002FSMD\u002FSMP or lymphoid neoplasm requiring allogeneic stem cell transplantation\n* In complete response (CR) for AML\u002FALL or CR,partial response (PR) or non pre-treated for SMD\u002FSMP and lymphoid neoplasm\n* Without a HLA matched related donor available and with identification of a haploidentical donor (brother, sister, parents, adult children or cousin)\n\nWith usual criteria for HSCT:\n\n* ECOG ≤ 2\n* No severe and uncontrolled infection\n* Cardiac function compatible with high dose of cyclophosphamide\n* Adequate organ function: ASAT and ALAT ≤ 2N, total bilirubin ≤ 1.5N, creatinine clearance ≥30ml\u002Fmin (except if those abnormalities are linked to the hematological disease)\n\n  * Requiring a RIC or non myeloablative conditioning:\n\n    (i) \\>50 years old; (ii) heavily pre-treated; (iii) Comoribidities according to Sorror et al. Blood 2005;106(8):2912-9, notamment HCT\u002FCI≥ 3 (JAMA. 2011 Nov 2;306(17):1874-83).\n  * With health insurance coverage (bénéficiaire ou ayant droit)\n  * Understand informed consent or optimal treatment and follow-up\n  * Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment and within 12 months for women of childbearing age and 6 months for men of childbearing age after the last dose of cyclophosphamide\n\nExclusion Criteria:\n\n* History of Cancer in the last 5 years\n* Uncontrolled infection: Seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive PCR HBV or HCV and hepatic cytolysis due to HBV\n* Uncontrolled coronary insufficiency, recent myocardial infarction \\\u003C6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction \\\u003C50%\n* Pulmonary failure with DLCO\\\u003C50%\n* Addition of immunosuppressant treatment for GVHD prophylaxis (except immunosuppressant allowed per protocol)\n* Renal failure with creatinine clearance \\\u003C50ml \u002F min\n* Pregnancy (β-HCG positive) or breast-feeding\n* Any debilitating medical or psychiatric illness which would preclude the realization of the SCT or the understanding of the protocol\n* Under protection by law (tutorship or curatorship)\n* Unwilling or unable to comply with the protocol","70 Years",{"count":151,"type":21},12,[107],"Despite progress in chemotherapy, targeted therapy and immunotherapy, allogeneic hematopoietic stem cell transplantation (allo-SCT) is still the only curative procedure for some hematological malignancies. The probability of finding a matched sibling donor (MSD) is estimated under the classical 30%, because of the age of patients and their relatives, and a matched unrelated donor (MUD) can take time to identify. Currently in France, 25% of the allo-SCT are performed with an haplo-identical related donor. The Baltimore group developed an approach using haploidentical related donors, RIC, T-replete bone marrow and post-transplant high dose cyclophosphamide (PTCy) in patients with advanced hematological malignancies. PTCy has shown to eradicate alloreactive donor and host T-cells, activated by respective antigens, thereby reducing the incidence of graft versus host disease (GvHD) but delaying hematopoietic recovery. Therefore, the main source of graft is peripheral blood stem cells (PBSC) mobilized by G-CSF in France. Unfortunately, with PBSC we observe a higher cumulative incidence of GvHD (around 50%) and a higher toxicity-related mortality (TRM), especially for recipients \\>50 years old. The co-transplantation of Mesenchymal Stem Cells (MSC) at the time of transplantation has previously shown a double interest in GvHD immunomodulation and hematopoiesis support. Pre-clinical studies (in mice) have shown that mesenchymal stromal cells (MSCs) from Wharton's Jelly reduce the incidence of GvHD when the infusions are weekly repeated. We propose a phase I clinical trial to find the maximum tolerated dose (MTD) of a weekly infusion of WJ-MSC administered as GvHD prophylaxis and as a support for a faster hematological reconstitution after haplo-identical allo-SCT.",[155,25,156],"Allogeneic Disease","Graft Failure","NOT_YET_RECRUITING","2023-05-04",{"date":160,"type":30},"2023-05-11",{"date":162,"type":21},"2023-09",{"date":164,"type":21},"2026-09",{"name":166,"class":37},"Central Hospital, Nancy, France"]