[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"graft-versus-host-diseasegvhd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:graft-versus-host-diseasegvhd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100636827","phase-2-low-dose-atgptcy-plus-ivarmacitinib-for-agvhd-prevention-in-haplo-pbsct-from-parous-female-donors-100636827",false,"NCT07570745","Low-Dose ATG\u002FPTCy Plus Ivarmacitinib for aGVHD Prevention in Haplo-PBSCT From Parous Female Donors","Low-Dose ATG\u002FPTCy Plus Ivarmacitinib to Prevent Acute Graft-versus-Host Disease Following Haploidentical Peripheral Blood Stem Cell Transplantation From Parous Female Donors: A Prospective, Single-Arm, Multicenter Trial","PARITY","Inclusion Criteria:\n\n1. Age 18-70 years, any gender. Recipients must be diagnosed with hematologic malignancies, such as acute leukemia, myelodysplastic syndrome, or malignant lymphoma, and are planned to undergo haploidentical peripheral blood stem cell transplantation (Haplo-PBSCT).\n2. The donor must be a haploidentical relative within three degrees of kinship and a parous female (having given birth; number of pregnancies not limited), aged 18-55 years, in good health, and cleared by donor screening.\n3. Karnofsky performance status ≥70. The recipient is expected to tolerate transplant-related toxicity. Major organ functions must meet transplantation requirements: cardiac and pulmonary function essentially normal; liver function: ALT\u002FAST \\\u003C2× upper limit of normal, total bilirubin \\\u003C1.5× upper limit of normal; renal function: creatinine clearance \\>50 mL\u002Fmin.\n4. No active infection prior to transplantation (or infection effectively controlled). Chronic infections such as HBV, HCV, or syphilis must be stable under treatment; HBV DNA negative or receiving antiviral therapy is acceptable.\n5. No significant psychiatric disorders; able to understand and voluntarily consent to participate in the study.\n6. The patient has signed the informed consent form and agrees to comply with follow-up and related examinations.\n\nExclusion Criteria:\n\n1. History of prior hematopoietic stem cell transplantation (including autologous or allogeneic transplant).\n2. Presence of donor-specific antibodies (DSA) with a mean fluorescence intensity (MFI) ≥5000.\n3. History of severe hypersensitivity or allergy to JAK inhibitors or the investigational drug.\n4. Prior treatment with JAK1\u002F2 inhibitors.\n5. Uncontrolled comorbidities prior to transplantation, such as uncontrolled hypertension, diabetes complications, or active gastrointestinal ulcer bleeding, which may increase unacceptable risk for trial participation as evaluated by investigators.\n6. Receipt of other investigational drugs within 2 weeks prior to transplantation (excluding standard chemotherapy), or simultaneous participation in other interventional clinical studies, or any other condition deemed by the investigator to make the patient unsuitable for study participation, including poor compliance or inability to complete follow-up (e.g., severe psychiatric disorders preventing cooperation).","ALL","18 Years","70 Years",{"count":21,"type":22},82,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Graft-versus-host disease (GVHD) is a major complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), significantly affecting survival and quality of life. Acute GVHD (aGVHD) typically occurs within 100 days post-transplant, commonly involving skin, gastrointestinal tract, and liver. Chronic GVHD (cGVHD) can appear months to years later.\n\nDespite prophylaxis with calcineurin inhibitors (e.g., cyclosporine or tacrolimus), methotrexate, mycophenolate mofetil, and post-transplant cyclophosphamide (PTCy), patients receiving haploidentical transplantation from parous female donors remain at high risk for moderate-to-severe aGVHD.\n\nJAK1-dependent cytokine signaling (IL-6, IFN-γ) is central to GVHD pathogenesis. Selective JAK1 inhibition may attenuate T cell-mediated inflammation while preserving hematopoiesis. Ivarmacitinib (SHR0302) is a highly selective oral JAK1 inhibitor, showing favorable safety and preliminary efficacy in autoimmune and GVHD settings, making it a candidate for early GVHD prophylaxis.",[28,29],"Graft-Versus-Host Disease(GVHD)","Bone Marrow Transplantation",[31,32,33,34],"Graft-versus-host disease","Haploidentical transplantation","Low-dose ATG\u002FPTCy","JAK1 inhibitor (Ivarmacitinib \u002F SHR0302)","RECRUITING","2026-05-01",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":36,"type":22},{"date":42,"type":22},"2029-05-01",{"name":44,"class":45},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100585705","phase-2-evaluation-of-allogenic-mesenchymal-stem-cell-msc-injection-therapy-for-refractory-graft-versus-host-disease-gvhd-unresponsive-to-conventional-treatments-100585705","NCT06905834","Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments","A Phase IIB Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments","TER-EYE","Inclusion Criteria:\n\n* Patients over 18 years of age who understand and sign the informed consent form.\n* Diagnosis of severe GVHD (graft versus host disease) according to NIH criteria (revised by Lee SJ in 2017) with ocular involvement in the form of severe SOD (severe ocular disease) in both eyes for more than 3 months, objectively defined as superficial punctate keratitis \\>2 on the Oxford scale (range 0-5) and\u002For the presence of epithelial defect, and subjectively as severe symptoms, \\>33 points on the OSDI questionnaire (0-100).\n* Patients must have previously been treated for at least three months with blood derivatives and\u002For insulin eye drops and topical cyclosporine or tacrolimus (unless any of these treatments were not tolerated and had to be discontinued).\n* Patients must be using ocular lubricants at least 4 times a day and, despite this, still meet the criteria for severe SOD as outlined in point 2.\n* Patients on low doses of topical corticosteroids for maintenance should have a stable dose for at least one month prior to inclusion.\n* The dose and frequency of all topical medications the patient begins the trial with must remain unchanged throughout the duration of the trial, unless otherwise judged by the investigator.\n* The chronic GVHD systemic treatment should be stable regarding the use of systemic immunosuppressors for at least one month prior to patient inclusion or before starting treatment.\n* Negative result in the urine pregnancy test at the baseline visit for women of childbearing age. Subjects must be advised to use contraceptive methods during their participation in the clinical trial and undergo a new pregnancy test at the treatment visit if more than 28 days have passed since the baseline visit.\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease or any condition that, in the medical judgment, could put the patient at risk or affect the interpretation of the results.\n* Uncontrolled systemic GVHD.\n* Active ocular infection.\n* Ocular surgery within the last 3 months.\n* Initiation of topical therapies for SOD indicated in the inclusion criteria less than 3 months prior to inclusion.\n* Start of topical corticosteroid use within 4 weeks prior to inclusion.\n* Cognitive impairments that could interfere with study compliance.\n* Pregnant women or women during the lactation period.",{"count":56,"type":22},30,[25],"This Phase IIB, multicenter, double-blind, randomized, and uncontrolled clinical trial aims to assess the efficacy and safety of subconjunctival injection of Mesenchymal Stem Cells (MSCs) in patients with Graft-versus-Host Disease (GVHD) and severe ocular involvement (DYD-dry eye disease). The primary objective is to evaluate the clinically and statistically significant improvement in the signs and symptoms associated with the disease.\n\nSecondary objectives include:\n\n* Analyzing adverse events related to the subconjunctival injection of MSCs to confirm the safety of this treatment in patients with GVHD ocular involvement.\n* Identifying new biomarkers that can be used to objectively assess the progression of patients with GVHD and severe ocular involvement.\n* Studying the relationship between the expression of ocular surface-specific markers by MSCs and their clinical efficacy, as well as the variation in the expression of these markers in relation to cell preservation methods.\n\nAssessing the quality of life of patients treated with two doses of MSCs using the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire).\n\n\\- Evaluating whether the cell dose impacts clinical improvement.\n\nThe trial includes 30 patients, divided into two groups of 15, and focuses on the assessment of dry eye disease, with the treatment based on MSC administration to improve clinical outcomes and quality of life for the patients.",[60,28],"Dry Eye Disease (DED)",[62,63,64],"dry eye disease","Graft-versus-Host Disease","mesenchymal stem cells","NOT_YET_RECRUITING","2026-03-24",{"date":68,"type":39},"2026-03-27",{"date":70,"type":22},"2026-05",{"date":72,"type":22},"2028-06",{"name":74,"class":45},"Instituto de Investigación Biomédica de Salamanca"]