[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gvhd---graft-versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gvhd---graft-versus-host-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,73,101,131,151,184,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100648730","phase-1-study-to-evaluate-the-safety-and-effectiveness-of-withaferin-a-as-a-treatment-to-prevent-gvhd-in-transplant-patients-100648730",false,"NCT07724873","Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant Patients","A Phase I\u002FII Trial to Assess Safety and Activity of Standardized Withaferin A as GvHD Prophylaxis in Patients Undergoing Matched Related Donor Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. ECOG performance score of 0 or 1\n2. Adequate liver function (Total serum bilirubin \\\u003C twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 3-fold higher than laboratory upper normal limits)\n3. Adequate renal function (creatinine clearance \\> 50 ml\u002Fmin)\n4. Adequate cardiac function (LVEF\\>40%)\n5. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.\n6. Signed, written informed consent\n\nExclusion Criteria: -\n\n1. Known hypersensitivity or contraindications against Withaferin-A.\n2. Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n3. Any medical or psychiatric illness which precludes the participant from giving informed consent\n4. Pregnancy, lactation, or inadequate contraception.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","What is acute Graft versus host disease (aGvHD)? GvHD is a complication that can occur after an allogeneic stem cell transplant resulting in damage to some organs. The death rate of GvHD patients is 15-40%. In GvHD, the donated peripheral blood stem cells or bone marrow view the recipient's body as foreign, and the donated cells\u002Fbone marrow harm the body. aGvHD usually develops in skin, liver or gastrointestinal tract, and symptoms might appear within few weeks after transplant. Symptoms of acute GvHD are observed as skin rash or reddened areas on the skin, yellow discoloration of the skin and\u002For eyes, and abnormal blood test results, nausea, vomiting, diarrhea, or abdominal cramping.\n\nWhat is the current prevention used for GvHD? To prevent development of GvHD many standard drugs like cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide are given.\n\nWhat is standardized Withaferin-A (SWA)? Withaferin-A (WA) is the main active component of Withania somnifera (Ashwagandha). It has been shown in many studies to have properties of healing and immune-modulation (improving the immune system). Studies have been done in our Clinical Pharmacology Laboratory that have shown a significant beneficial effect of this drug, when added to the standard drugs used for prophylaxis of GvHD, on reducing the risk of acute GvHD. The drug has also been tested and proven to be very safe in humans.\n\nWhat is the rationale of this trial? As has been described earlier, GvHD is a difficult complication of allogeneic stem cell transplant which can lead to increased hospital stay and deaths post-transplant. The standard drugs for prevention of GvHD are cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cyclophosphamide. These drugs also have some side effects during the course of transplant. This points out the need for new preventive drugs that are safe and effective.\n\nSWA is an oral formulation of WA which seems to be beneficial in the early studies done in the Clinical Pharmacology Laboratory, ACTREC. SWA has also been found to be safe at very high doses.\n\nSWA will be given along with the standard drugs given to prevent GvHD. Despite of consuming these drugs, about 40 - 60% patients still develop GvHD. The investigators aim to add SWA to these standard drugs during transplant to reduce significant aGvHD.\n\nHow will SWA be given? Participants who agree to participate in this trial and are found to be eligible will be given SWA as a capsule at a dose of 500 mg\u002Fday (2 capsules of 250 mg) to 3000 mg\u002Fday (6 capsules of 250 mg) as per the dose level allotted to the Patient. The drug will be given for a total duration 90 days starting from Day +1 of transplant. All other standard treatments which are part of a transplant procedure will be carried out without any change.\n\nParticipants will be monitored clinically for any adverse events and followed up as per standard protocols post-transplant.\n\nWhat additional tests will be carried out? Additional blood sampling to study the levels of the drug WA blood samples will be collected at 0, 1, 2, 4, 8 hours on the day of start of SWA (Day +1) and Day +7. Checking immune cell profile and cytokines (which are markers of - immunity levels) will be done at Day+30, Day +90, Day+180, Day+365 from the start of SWA which is also the part of routine care. Blood sample of 5 ml will also be taken at Day 0, Day +14, Day +30, Day +60 and Day +90 after start of drug to see level of some special protein called JAK2 STAT3 protein.\n\nWhat are the risks involved in participation? According to available literature and information, SWA is a safe and well tolerated drug. In a phase 1 study, Standardized Withaferin-A was administered to Patients with advanced stage osteosarcoma. The drug was well tolerated by Patient up to a dose of 4800 mg. No severe side effects were observed. Increase in liver enzymes and skin rash were the most common side effects. Other side effects included fatigue, fever, swelling, and diarrhea.\n\nWhat is the possible impact of this trial? If indeed SWA works and prevents GvHD effectively then this could be a breakthrough in treatment. It would help many Pateints to prevent GvHD post allogeneic stem cell transplant and would be a safe, easily available, inexpensive and oral drug for the same. This possibly could benefit and help future Patients who undergo bone marrow transplant (BMT) to have better chances of survival and reduce their financial burden.",[27,28,29],"Hematopoietic Stem Cell Transplant (HSCT)","GVHD - Graft-Versus-Host Disease","Hematological Malignancy",[31,32],"Standardized Withaferin A","Matched related donor Hematopoietic stem cell transplant","RECRUITING","2026-07-20",{"date":36,"type":37},"2026-07-24","ACTUAL",{"date":39,"type":37},"2025-01-28",{"date":41,"type":20},"2029-12-03",{"name":43,"class":44},"Tata Memorial Centre","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100647328","phase-2-study-of-standardized-withaferin-a-for-the-treatment-of-steroid-refractory-acute-graft-versus-host-disease-100647328","NCT07708987","Study of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease.","A Phase II Clinical Trial of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease","Withaferin_A","Inclusion Criteria:\n\n* Patients age ≥ 12 years with a hematological malignancy who have undergone allogeneic stem cell transplant with matched related donor (MRD), Haploidentical (Haplo) donor or matched unrelated donor (MUD)\n* Evidence of myeloid engraftment (eg, absolute neutrophil count ≥0.5 × 109 \u002FL for 3 consecutive days)\n* ECOG performance score of 0 or 1\n* Patients with steroid-refractory aGvHD, defined as any of the following:\n* Patients with progressive GvHD (ie, increase in stage in any organ system or any new organ involvement) after 3 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients with GvHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 7 days of primary treatment with methylprednisolone ≥2 mg\u002Fkg\u002Fd (or equivalent)\n* Patients who previously began corticosteroid therapy at a lower dose (≥1 mg\u002Fkg\u002Fd methylprednisolone) for treatment of skin GvHD or skin GvHD accompanied by upper gut GvHD but develop new GvHD in another organ system\n* Patients who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg\u002Fkg\u002Fd, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindications against Withaferin-A.\n* Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection.\n* Any medical or psychiatric illness which precludes the participant from giving informed consent.","12 Years","65 Years",{"count":57,"type":20},34,[24],"Study Design Prospective, single center, single arm, Phase II study.\n\nResearch aims and objectives Aim:\n\nTo evaluate the efficacy and safety of standardized Withaferin A in steroid refractory acute GvHD in patients post allogeneic stem cell transplantation\n\nPrimary Objective:\n\nTo evaluate the objective Response Rate (ORR) at Day 28 from the start of SWA defined as the proportion of patients achieving Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR).\n\nMethodology\n\nTreatment plan and Interventions Administration of study treatment Name of the intervention: Standardized WA (standardized root extract of Withania somnifera. This will be provided free of cost to the trial patients.\n\nFormulation: The standardized root extract of W. somnifera contains 5% of WA w\u002Fw. SWA is available as a 500 mg capsule (AshwaMAX) that contains 25 mg of WA.\n\nRoute of administration: Per-oral (P\u002FO) Dose schedule: The dose of SWA is 1500mg\u002Fday. It will be administered as 3 capsules of 500 mg once a day.\n\nDuration of treatment:\n\n* Every patient will receive treatment for at least 12 weeks followed by a taper as per physician's discretion. WA can be tapered after 12 weeks if the patient has achieved CR or VGPR and has discontinued corticosteroids for at least 4 weeks.\n* Dose adjustments\u002Fmodifications: If the patient experiences any grade ≥3 toxicities related to SWA, further administration of SWA will be withheld immediately. Once the severity of the adverse event reduces to grade ≤1, the study agent will be rechallenged with 25% dose reduction. The same strategy will be adopted for successive grade ≥3 toxicities. If the drug is not tolerated at 25% of original dose (100 mg), no further rechallenge will be attempted.\n* Corticosteroid tapering will be done as per the treating physician's discretion and clinical condition of the patient.",[29,28,61],"Steriod Refractory",[63],"Withaferin A","2026-07-11",{"date":66,"type":37},"2026-07-16",{"date":68,"type":37},"2023-09-23",{"date":70,"type":20},"2028-09-25",{"name":43,"class":44},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":72},"100644940","phase-1-phase-i-ii-ptcy-bortezomib-and-sitagliptin-for-prevention-of-gvhd-following-allogeneic-hsct-100644940","NCT07675174","Phase I-II PTCy, Bortezomib and Sitagliptin for Prevention of GvHD Following Allogeneic HSCT","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\n1. Patients with any of the following hematologic malignancies:\n\n   1. AML in first remission (CR1) if they have intermediate- or high-risk cytogenetic and\u002For molecular features, or patients in second or subsequent complete remission (CR2, CR3, etc.). Complete remission is defined as presence of \\\u003C5% blasts in the bone marrow with no morphological evidence of leukemia. Patients in CR with incomplete count recovery may be included.\n   2. ALL with any of the following in CR1 or subsequent complete remission (CR2, CR3, etc.). Complete remission is defined as presence of \\\u003C5% blasts in the bone marrow with no morphological evidence of leukemia. Patients in CR with incomplete count recovery may be included.\n   3. MDS with a revised International Prognostic System Score (IPSS-R) of greater than 3 at diagnosis. Patients must have \\\u003C10% blasts in the bone marrow documented within 30 days of transplant.\\*\n   4. Therapy-related myelodysplastic disorder (t-MDS). Patients must have \\\u003C10% blasts in the bone marrow documented within 30 days of transplant.\\*\n   5. CMML type 1 or 2. Patients must have \\\u003C10% blasts in the bone marrow documented within 30 days of transplant.\\* \\*Patients with MDS, t-MDS, and CMML will be included only in the phase I portion of the study.\n2. Patient age ≥ 18 years\n3. KPS ≥70%\n4. Patients must also be suitable to receive an RIC regimen at the discretion of the treating physician. While there are not universally accepted or validated cut-off criteria of age, performance status, or HCT-CI for suitability for RIC, RIC transplants should be considered for patients 60 years and older and for patients \\\u003C60 years who are \"less fit\" (e.g., KPS \\\u003C90% and\u002For HCT-CI ≥3 due to lower non-relapse mortality associated with RIC).\n5. Patients receiving allogeneic PBSC grafts from HLA-matched (5\u002F6 and 6\u002F6 matches) siblings or matched unrelated donors (7\u002F8 or 8\u002F8 matches at HLA-A, B, C, DRB1 by high resolution typing) are included. All grafts will be unmanipulated (i.e., no T cell depleted or CD34 selected grafts). In addition, donors should meet institutional criteria for donation of PBSC, as well as the screening and eligibility criteria of the (NMDP) for unrelated donors, and the requirements of the United States Food and Drug Administration for HCT\u002FP (21 CFR Part 1271).\n6. Required baseline laboratory values within 16 days prior to admission:\n\n   1. Estimated creatinine clearance \\>60 mL\u002Fmin\u002F1.72 m2\n   2. Serum total bilirubin ≤2 x upper limit of normal value (except for Gilbert's disease)\n   3. AST and ALT ≤3 x upper limit of normal value\n   4. ALP ≤250 IU\u002Fl\n7. Required baseline values within 60 days prior to admission:\n\n   1. LVEF \\>40%\n   2. Adjusted carbon monoxide diffusing capacity (DLCO) \\>50%\n8. No evidence of HIV infection (patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies)\n9. Non-pregnant and non-nursing\n10. Signed written informed consent (patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)\n11. Patients must otherwise fulfill institutional criteria for eligibility to undergo reduced-intensity allogeneic stem cell transplantation\n\nExclusion Criteria:\n\n1. 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 a minimum of 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.\n2. 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 (i.e., post- vasectomy).\n3. Inability to provide informed consent.\n4. 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.\n5. Patients with active central nervous system leukemia\n6. Prior allogeneic HSCT or an autologous HSCT in past 12 months\n7. Patients with diabetes mellitus requiring insulin secretagogues and\u002For insulin at time of enrollment\n8. Patients with a history of pancreatitis\n9. Patients with symptomatic cholelithiasis\n10. Known hypersensitivity to any of the components of the investigational treatment regimen\n11. Serious medical or psychiatric illness likely to interfere with participation in this clinical study\n12. 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\n13. 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\n14. Prisoners",{"count":81,"type":20},72,[23,24],"Phase I-II studying post transplant cyclophosphamide, bortezomib and sitagliptin for GvHD prevention in allogeneic HSCT. Adults with hematologic malignancies undergoing an RIC allogeneic PBSC transplant from a 5\u002F6 or 6\u002F6 sibling or 7\u002F8 or 8\u002F8 matched unrelated donor.",[28],[86,87,88,89,90],"GvHD","Allogeneic Transplant","Post transplant cyclophosphamide","Sitagliptin","Bortezomib","NOT_YET_RECRUITING","2026-06-23",{"date":94,"type":37},"2026-06-30",{"date":96,"type":20},"2026-07-01",{"date":98,"type":20},"2032-07-01",{"name":100,"class":44},"Northwell Health",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":72},"100607812","phase-3-reduced-post-transplant-cyclophosphamide-dose-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplantation-for-hematological-malignancies-100607812","NCT07193420","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies","Reduced Post-transplant Cyclophosphamide Dose in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplantation for Hematological Malignancies: a Phase III Randomized Study","REDUCy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed hematological malignancy with an indication for allogeneic HSCT\n* Presence of a haploidentical donor willing to donate PBSC\n* Patient planned to receive a thiotepa-based conditioning regimen\n* Provision of written informed consent Affiliation to a social security system (excluding \"Aide Médicale d'État\")\n\nExclusion Criteria:\n\n* Karnofsky performance status \\\u003C 70%\n* Life expectancy \\\u003C 1 month, as determined by the attending physician\n* Acute or chronic heart failure, defined as left ventricular ejection fraction \\\u003C 40%\n* Pulmonary dysfunction with diffusion capacity \\\u003C 50% of predicted values\n* Renal impairment with estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin (calculated using the CKD-EPI formula)\n* Decompensated hemolytic anemia\n* Fanconi anemia and other DNA breakage repair disorders\n* Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy\n* Obstruction of urinary outflow\n* Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines\n* Combination with products containing Hypericum perforatum\n* Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and\u002For life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren\n* Active non-controlled infectious disease\n* Positive HIV status\n* Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose\n* Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision)\n* Hypersensitivity to the active substance or any of the excipients\n* Concurrent participation in another investigational therapeutic study\n* Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to:\n\n  * Significant language barrier in the absence of adequate translation support\n  * Social or geographic situation preventing follow-up and adherence to visit schedule\n  * Ongoing substance abuse likely to interfere with protocol compliance\n  * Documented cognitive or functional impairment not otherwise covered under legal protection",{"count":110,"type":20},180,[112],"PHASE3","Phase III comparative, open-label, randomized (1:1) trial designed to evaluate the efficacy of reducing the total dose of PTCy to 70 mg\u002Fkg on GREFS compared to the standard dose of 100 mg\u002Fkg, in patients undergoing haploidentical HSCT for the treatment of a hematological malignancy, two years after HSCT.",[28,115,116],"HSCT","Haploidentical Stem Cell Transplantation",[118,119,120,121],"Cyclophosphamide toxicities","Cyclophosphamide dose reduction","Graft-Versus-Host Disease: GVHD","Hematopoietic stem cell transplantation","2026-05-07",{"date":124,"type":37},"2026-05-12",{"date":126,"type":20},"2026-06",{"date":128,"type":20},"2030-06",{"name":130,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100636657","phase-3-a-randomized-double-blind-placebo-controlled-multicenter-phase-iii-trial-of-remestemcel-l-rknd-added-to-ruxolitinib-for-grade-iii-iv-steroid-refractory-acute-graft-versus-host-disease-100636657","NCT07568535","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease","Inclusion Criteria:\n\n1. Age 18 years or older at the time of enrollment.\n2. Able to take oral medications\n3. Have Grade III-IV SR-aGVHD at the time of enrollment, defined as aGVHD resistant to high dose corticosteroids at a dose of ≥ 1 mg\u002Fkg\u002Fday methylprednisolone (or equivalent), given alone or in combination with GVHD prophylaxis agents such as CNI, mTOR inhibitor, or MMF.\n\n   1. The minimum time between the initiation of high-dose corticosteroids and enrollment is 3 days if aGVHD has progressed in at least one organ regardless of improvement in other organs, OR\n   2. Minimum time of 5 days for aGVHD showing no improvement in GI or liver symptoms, OR\n   3. Recurrence of Grade III-IV aGVHD after an initial response to steroid therapy.\n4. Prior use of ruxolitinib is permissible in the following cases:\n\n   1. If no more than 2 doses of ruxolitinib were taken for aGVHD treatment prior to enrollment.\n   2. If there was prior use of ruxolitinib for GVHD prophylaxis. If aGVHD developed while on ruxolitinib for GVHD prophylaxis or within 3 days of its discontinuation, the patient is not eligible.\n5. Evident myeloid and platelet engraftment. Absolute neutrophil count (ANC) \\> 1000\u002Fmm3 and platelets ≥ 20,000\u002F mm3. Use of growth factor supplementation and transfusion support is allowed.\n6. Minimum Karnofsky performance score of 30 at the time of study entry.\n7. Patient (or legal representative where appropriate) must be capable of providing written informed consent\u002Fassent.\n8. Female patients of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the entire duration of study participation. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device, or steroid contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.\n9. Male patients with partners of childbearing potential must agree to use adequate contraception (barrier method with spermicide or abstinence) for the entire duration of study participation.\n10. Willing and able to comply with study requirements, remain at the clinic, and return to the clinic for the follow-up evaluation, as specified in this protocol during the study period.\n\nExclusion Criteria:\n\n1. Underwent second allogeneic hematopoietic cell transplantation within six months from the first transplant.\n2. Received systemic treatment for aGVHD other than corticosteroids +\u002F- agents used for aGVHD prophylaxis (e.g., CNIs, mTOR inhibitor, and\u002For MMF).\n3. Respiratory disease requiring continuous positive pressure ventilation or intubation. Patients who need intermittent continuous positive airway pressure (e.g., during sleep) are eligible.\n4. Any underlying or current medical or psychiatric condition that, in the opinion of the investigator, would interfere with the evaluation of the patient.\n5. Post-transplant morphologic relapsed malignancy \\[defined as \\> 5% blasts on bone marrow examination and\u002For extramedullary relapse\\].\n6. Donor leukocyte infusion (DLI) for treatment of malignant disease relapse. Patients who received DLI for indications other than relapse, including for treatment of minimal residual disease (MRD) and mixed chimerism, are eligible.\n7. Prior treatment with any mesenchymal lineage cells, including remestemcel-L.\n8. Active or inadequately treated latent infection with Mycobacterium tuberculosis (i.e., tuberculosis).\n9. Female patients who are pregnant, lactating, or planning a pregnancy during the expected remestemcel-L treatment period.\n10. Concurrently receiving an investigational agent, device or procedure. An investigational agent, device or procedure is defined as having no known FDA-approved indications. Any prior and\u002For current participation in a clinical trial of an investigational medicinal product (IMP) that is registered and being used off label requires review by the study's Protocol Officer, Protocol Chairs, and Sponsor prior to enrollment.\n11. Known hypersensitivity to DMSO or to porcine or bovine proteins.\n12. Requiring vasopressor support.\n13. Uncontrolled infections. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Persistent fever without other signs or symptoms will not be interpreted as progressing infection. Progression of infection is defined as: hemodynamic instability attributable to sepsis OR new symptoms attributable to infection OR worsening physical signs attributable to infection OR worsening radiographic findings attributable to infection. Patients with radiographic findings attributable to infection within 4 weeks prior to enrollment must have a repeat radiographic exam within one week of enrollment that documents stable or improved findings.\n14. Estimated creatinine clearance less than 15 mL\u002Fmin or those requiring hemodialysis.\n15. Clinically significant liver disorders or bilirubin greater than 3 mg\u002Fdl not attributable to aGVHD or Gilbert's.\n16. Moderate to severe cGVHD that require systemic treatment. Chronic GVHD that is not requiring systemic therapy is allowed.",{"count":110,"type":20},[112],"This study is a randomized, double-blind, placebo-controlled, multicenter Phase III trial to compare the efficacy and safety of remestemcel-L-rknd (remestemcel-L), ex-vivo cultured adult human mesenchymal stromal cells (MSC), combined with ruxolitinib vs. ruxolitinib combined with placebo as second-line therapy in adult patients with Grade III-IV steroid-refractory acute graft-versus-host disease (SR-aGVHD).",[28],"2026-04-28",{"date":143,"type":37},"2026-05-05",{"date":145,"type":20},"2026-08-31",{"date":147,"type":20},"2028-07",{"name":149,"class":150},"Mesoblast, Ltd.","INDUSTRY",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":159,"enrollmentInfo":160,"targetDuration":162,"studyType":163,"phases":4,"briefSummary":164,"conditions":165,"keywords":171,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":72},"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":161,"type":20},200,"1 Year","OBSERVATIONAL","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.",[166,28,167,168,169,170],"GVHD, Chronic","GVHD","Quality of Life","Depression Disorders","Cognitive Impairments",[86,172,173,174],"depression","quality of life","Cognitive impairment","2025-12-18",{"date":177,"type":37},"2026-01-02",{"date":179,"type":37},"2025-04-08",{"date":181,"type":20},"2028-10",{"name":183,"class":44},"Medical University of Gdansk",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":72},"100574190","phase-2-comparing-the-therapeutic-effects-of-using-ruxolitinib-and-steroids-concurrently-to-steroids-alone-as-initial-treatment-in-patients-diagnosed-with-chronic-graft-versus-host-disease-at-a-grade-of-moderate-or-higher-severity-100574190","NCT06756061","Comparing the Therapeutic Effects of Using Ruxolitinib and Steroids Concurrently to Steroids Alone as Initial Treatment In Patients Diagnosed With Chronic Graft-versus-host Disease at a Grade of Moderate or Higher Severity","A Nation-wide, Multi-center, Prospective, Randomized, Parallel-group, Open-label, Investigator Initiated Pilot Study to Evaluate Efficacy and Safety of Systemic Corticosteroid Plus Ruxolitinib as First-line Therapy in Patients With New-onset Moderate to Severe Chronic Graft-versus-host Disease","FRONTJAK-001","\\[Inclusion Data\\]\n\n1. Adult men and women aged 19 or older based on the date of signing on the informed consent form\n2. On the screening visit, those who are diagnosed of a moderate to severe chronic graft-versus-host disease according to 2014 NIH consensus criteria\n\n   -Moderate: At least one of the following conditions: \\>1 point for at least three organs \\>2 points for at least one organ except the lungs \\>1 point for the lungs\n\n   -Severe: At least one of the following conditions: \\>3 points for at least one organ\n   * At least 2 points for the lungs\n3. Those who have no history of systemic treatment for chronic graft-versus-host disease and now need systemic corticosteroid treatment\n4. Those whose ECOG (Eastern Cooperative Oncology Group) performance status is 0 to 2.\n5. Regardless of the donor (matched sibling-family donor, matched unrelated donor, or partially matched family donor), those who have successfully taken same-type stem cell transplantation (alloSCT) from the marrow, peripheral blood stem cell, or cord blood\n6. Those who voluntarily agree on participation in this clinical trial\n\n\\[Exclusion Data\\]\n\n1. Those who meet the following criteria in laboratory tests during the screening and randomization visits\n\n   * Those whose platelet count is less than or equal to 25,000\u002Fmm3 without blood transfusion\n   * Those whose absolute neutrophil count is less than or equal to 1,000\u002Fmm3\n   * Those whose total bilirubin \\> 3 x ULN for any reason other than chronic graft-versus-host disease\n2. Those with gastrointestinal troubles that hinder the intake and absorption of IMPs and concomitant medicines (systemic corticosteroid) (e.g.: signs such as ulcerative disease, unregulated nausea, vomiting, diarrhea, malabsorption, etc. or small intestine removal)\n3. Those with a history of graft-versus-host disease treatment\n\n   * Corticosteroid administration is permitted for chronic graft-versus-host disease treatment within 72 hours before the randomization visit\n   * Except those who had therapeutic or preventive use of systemic corticosteroids and\u002For systemic immunosuppressants (CNI, MMF) for acute graft-versus-host disease (In case of prednisone administration for maintenance, only 0.5 mg\u002Fkg\u002Fday or less is permitted)\n4. Those to whom the treatment for chronic graft-versus-host disease cannot begin as prednisone ≥ 0.5 mg\u002Fkg\u002Fday\n5. Those whose same-type stem cell transplantation (alloSCT) has been confirmed as engraft-failed within 6 months before the screening visit\n6. Those with an experience of ruxolitinib administration for acute graft-versus-host disease treatment (however, the patient may participate on the assumption that the response to the acute graft-versus-host disease treatment reaches the level of complete or partial response and that there is no ruxolitinib administration history within 4 weeks before the randomization visit. In addition, if ruxolitinib administration was for another disease, the patient may participate unless there is no history of ruxolitinib administration within 4 weeks before the randomization visit.)\n7. Those who suffer chronic graft-versus-host disease after an unscheduled donor lymphocyte infusion for proactive treatment to prevent the recurrence of a malignant tumor (Participation is allowed if the scheduled lymphocyte infusion is performed as part of the transplantation procedure, not for the prevention of the recurrence of a malignant tumor.)\n8. Those found to have the following history in the screening visit:\n\n   * Relapsed primary malignancy\n   * Those found to involve an unregulated sinusoidal obstruction syndrome\n   * Those with a history of progressive multifocal leukoencephalopathy (PML)\n   * Nephropathy whose creatinine clearance rate is lower than 30 mL\u002Fmin (Cockroft Gault equation)\n   * Infections that are clinically active and uncontrolled, requiring treatment, including significant bacteria, fungi, viruses, or parasitic infections. (However, if there are no signs of progression at the time of screening due to appropriate treatment, the infection is considered controlled. The progression of infection is defined by hemodynamic instability due to sepsis, new symptoms caused by the infection, worsening physical signs, or radiological findings. A persistent fever without other signs or symptoms is not interpreted as progressive infection.)\n   * Active tuberculosis\n   * HIV-infected individual\n   * Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) that the investigator views as significant\n   * Cardiovascular disease that the investigator considers as clinically significant (acute cardiac infarction (within 6 months before randomization), NYHA class III or IV congestive heart failure, unstable angina (within 6 months before randomization), clinically significant symptomatic cardiac arrhythmia (e.g.: continued ventricular tachycardia, clinically significant level 2 or 3 AV blockage with no pacemaker used), unregulated hypertension)\n9. Those allergic or sensitive to additives of IMPs and concomitant medicines (systemic corticosteroid) or similar compounds\n10. Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, glucose - galactose malabsorption, etc.\n11. Those who are administrated with more than 200 mg of Fluconazole per day\n12. Those being treated with systemic medicines that may hinder blood coagulation or platelet functions such as aspirin, heparin, and warfarin (However, those whose aspirin administration does not exceed 150 mg\u002Fday may participate.)\n13. Pregnant or breast-feeding women\n14. Those who do not agree on utilizing proper methods of contraception(e.g. a copper intrauterine device (copper loop), an intrauterine device containing hormones, condoms, a vasectomy, tubal surgery, a spermicide, a vagina-inserted contraceptive, a subdermal implant, an injectable contraceptive, a female condom, oral contraceptive, etc.) during the period of this clinical trial(the period of IP administration and at least 30 days after IP administration ends)\n15. Those who have participated in another clinical trial within 30 days before the screening visit and have a history of IMP administration\u002Fmedical equipment application (However, if the investigator views such a previous trial as not affecting this clinical trial's efficacy and safety assessment such as observational study or retrospective study, the subject may participate.)\n16. Those whose participation in this clinical trial is viewed as inappropriate in the investigator's opinion.","19 Years",{"count":194,"type":20},88,[24],"Chronic graft-versus-host disease (cGVHD) is a complication that occurs in 30-40% of recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) and is a major cause of late non-relapse mortality. In cases where the initial treatment response is inadequate, irreversible tissue damage often persists, making it a fatal complication that significantly reduces quality of life even for long-term survivors.\n\nTherefore, the success of first-line treatment is crucial, but to date, there are no approved drugs specifically for the first-line treatment of chronic graft-versus-host disease. Besides corticosteroids, which have been used palliatively for over 50 years, there are no proven effective treatments available.\n\nAgainst this background, this study was designed to explore the potential of new treatments as first-line therapy for chronic graft-versus-host disease, where effective treatment options are currently lacking.\n\nInitially, the objective response rate will be analyzed at the 48-week mark based on the NIH Consensus Criteria (Lee 2015). Additionally, the study will evaluate the proportion of patients with steroid-resistant or steroid-dependent conditions, the objective response rate(ORR), failure-free survival(FFS), duration of response(DOR), and the proportion of patients who have reduced corticosteroids. Furthermore, the differences in treatment effects between the two groups of patients will be analyzed based on safety endpoints, including adverse events, laboratory tests, physical examinations, and vital signs.",[28,198,199],"Neoplasms","Haematopoietic Stem Cell Transplantation",[201,202,203],"GvHD-Graft-Versus-Host-Disease","ruxolitinib","first-line","2025-02-18",{"date":206,"type":37},"2025-02-19",{"date":208,"type":37},"2025-01-15",{"date":210,"type":20},"2029-08-31",{"name":212,"class":44},"Byung-Sik Cho",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":221,"conditions":222,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":45},"100571038","cell-free-dna-profiling-as-a-tool-to-monitor-clinically-relevant-events-in-allogeneic-hematopoietic-stem-cell-transplantation-100571038","NCT06715046","Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patient must be affected by an hematological malignancy requiring hematopoietic stem cell transplantation (HSCT).\n\nExclusion Criteria:\n\n* Patients can not be 17 years old or yunger",{"count":220,"type":20},30,"Allogeneic hematopoietic stem cell transplantation (HSCT) is a life-saving treatment for people with severe blood-related diseases. However, it comes with serious risks, including a condition called graft-versus-host disease (GVHD), where the transplanted cells attack the patient's body. GVHD can occur in about 50% of patients acutely and 35% in a chronic form, potentially affecting organs like the skin, liver, and gastrointestinal system. Currently, doctors diagnose GVHD based on symptoms, as there are no easy tests available.\n\nInfections can also be a problem after HSCT, as dormant viruses may reactivate. These infections are monitored using specialized tests. Additionally, doctors use advanced methods, like analyzing minimal residual disease (MRD) and chimerism, to check for the risk of the original disease coming back. MRD is tracked by looking for specific genetic markers of the disease in the patient's blood or bone marrow.\n\nAnother emerging tool involves analyzing cell-free DNA (cfDNA)-tiny fragments of DNA found in bodily fluids that come from dying cells. This technique, called liquid biopsy, has been revolutionary in areas like cancer detection, pregnancy testing, and organ transplants. For example, in organ transplants, cfDNA can indicate early signs of rejection, helping reduce the need for invasive biopsies.\n\nIn HSCT, the use of cfDNA to monitor complications like GVHD or relapse has not been fully explored. This pilot study aims to investigate whether analyzing cfDNA using a technique called epigenomic profiling can help detect acute GVHD, as well as other post-transplant issues like infections, disease relapse, and chronic GVHD. The goal is to compare cfDNA analysis to current testing methods to see if it offers better or earlier detection of complications.\n\nThis research could pave the way for improved, less invasive monitoring of HSCT patients, potentially leading to better outcomes and fewer complications.",[28,223,224,225,226],"Infections After HSCT","Transplant Associated Microangiopathy TAM","Sinusoidal Obstruction Syndrome (SOS)","HSCT Engraftment",[228,229,230,115,231],"cfDNA","methylation","epigenetic profile","liquid biopsy","2024-11-27",{"date":234,"type":37},"2024-12-04",{"date":236,"type":37},"2024-01-31",{"date":238,"type":20},"2026-12-31",{"name":240,"class":44},"University of Turin, Italy"]