[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647415":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":76,"collaborators":79,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":20,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":20,"enrollmentInfo":92,"targetDuration":20,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Leflunomide","EXPERIMENTAL","This will be a single arm open label intervention study. Patients who undergo haploidentical transplant, within 7 days of engraftment, will receive leflunomide till day+180 post transplant or till patient is on systemic immunosuppression.",[13],"Drug: Leflunomide 20 mg",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Leflunomide 20 mg","Patients in study shall receive loading dose of Tab Leflunomide 100 mg daily for 3 days followed by 20 mg daily orally. Leflunomide will be given till day 180 + post haploidentical transplant or till patient is on systemic immunosuppression.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lingaraj Nayak, MD, DM","CONTACT","91-9167294976","lingarajnayak86@gmail.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Sumeet Mirgh, MD, DM","91-8130140245","drsumeetmirgh@gmail.com",[32,53,64],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre","RECRUITING","Navi Mumbai","Maharashtra","410210","India","IN",{"type":41,"coordinates":42},"Point",[43,44],73.01582,19.03681,{"lat":44,"lon":43},[47,48,49,51],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":50,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":28,"role":52,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"facility":54,"status":55,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Advanced Centre for Treatment, Research and Education in Cancer","NOT_YET_RECRUITING",{"type":41,"coordinates":57},[43,44],{"lat":44,"lon":43},[60],{"name":61,"role":24,"phone":62,"phoneExt":63,"email":26},"Lingaraj Nayak Nayak L, MBBS,MD DM Medical Oncology","+91-22- 24177000","7210",{"facility":54,"status":55,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},{"type":41,"coordinates":66},[43,44],{"lat":44,"lon":43},[69,72,74],{"name":70,"role":24,"phone":71,"phoneExt":63,"email":26},"Dr. Lingaraj Nayak, MBBS,MD DM Medical Oncology","91 22 24177000",{"name":73,"role":24,"phone":20,"phoneExt":20,"email":30},"Dr Sumeet Mirgh, DM medical Oncology",{"name":75,"role":50,"phone":20,"phoneExt":20,"email":20},"Dr Lingaraj Nayak, MBBS MD DM Medical Oncology",{"type":50,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Dr Lingaraj Nayak","Professor, Medical Oncology",[80],{"name":81,"class":82},"Indian Council of Medical Research","OTHER_GOV","100647415","phase-2-leflunomide-to-prevent-cytomegalovirus-reactivation-in-stem-cell-transplant-patients-100647415",false,"NCT07709013","Leflunomide to Prevent Cytomegalovirus Reactivation in Stem Cell Transplant Patients","Use of Leflunomide as Primary Prophylaxis Against Cytomegalovirus (CMV) Reactivation in Haploidentical Haematopoietic Stem Cell Transplant (HIT) - Single, Arm, Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Males or females undergoing Haplo-identical haematopoetic stem cell transplant.\n2. Age ≥18yrs on the day of signing informed consent\n3. Undetectable CMV from plasma sample in preceding 7 days\n4. Patient who has WBC engraftment (ANC\\>=500\u002Fcumm for 3 or more consecutive days).\n5. Within 7 days of WBC engraftment\n6. Adequate liver functions (ALT \u002F AST less than 5 times upper limit of normal and Bilirubin \\\u003C=3 times upper limit of normal) at time of starting leflunomide\n7. Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to Leflunomide\n2. History of clinically significant CMV reactivation in past 1 year\n3. Patient is receiving\u002Fhas received drug known to have anti CMV activity within in last 7 days \\[Ganciclovir, valganciclovir, foscarnet, letermovir, acyclovir (at doses \\>=3200 mg PO per day or \\>=25 mg\u002Fkg IV per day), valacyclovir (at doses \\&\\>=3000 mg PO per day)\\]\n4. Inadequate renal function (creatinine clearance \\\u003C=30 ml\u002Fmin)\n5. Chronic active hepatitis B (HBsAg+ or any HBV DNA+), hepatitis C, or\u002Fand HIV\n6. Any psychiatric condition that might limit the ability of the patient to comply with the protocol","ALL","18 Years",{"count":93,"type":94},22,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","Patients undergoing half-matched hematopoietic stem cell transplantation (HSCT) are at high risk of viral reactivation after bone marrow transplantation (BMT). The purpose of this study is to evaluate whether leflunomide can prevent cytomegalovirus (CMV) reactivation in these patients and to assess its safety.\n\nThe main questions it aims to answer are -\n\n1. Does leflunomide prevent cytomegalovirus (CMV) related organ damage?\n2. Does leflunomide prevent a rise in cytomegalovirus (CMV) copy number to more than 2000 copies\u002Fml?\n3. Does leflunomide prevent the need to start pre-emptive therapy for cytomegalovirus (CMV)?\n4. Is it safe to use in bone marrow transplant ( BMT) patients?\n5. Does leflunomide prevent other viral reactivations - like Adeno virus and BK virus?\n6. Does leflunomide affect the risk of acute graft-versus-host disease ( acute GVHD) after bone marrow transplant (BMT)?\n\nWhat medicine will the patients receive? Patients in study shall receive loading dose of Tab. Leflunomide 100 mg daily for 3 days followed by 20 mg daily orally. Leflunomide will be given till day +180 post transplant or till patient is on immunosuppressant medicines.",[100],"Hematologic Malignancies",[102,9,103,104,105],"Cytomegalovirus (CMV) Reactivation","haplo-HSCT","Haploidentical","Hematopoietic stem cell transplant","2026-07-11",{"date":108,"type":109},"2026-07-16","ACTUAL",{"date":111,"type":109},"2024-10-18",{"date":113,"type":94},"2029-04",{"name":5,"class":6},3]