[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430719":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":226,"collaborators":228,"id":234,"slug":235,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":236,"sex":242,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":39,"studyType":248,"phases":249,"briefSummary":251,"conditions":252,"keywords":262,"overallStatus":70,"whyStopped":39,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},{"fullName":5,"class":6},"University of Birmingham","OTHER",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm Thymoglobulin + Cyclosporine + MMF","ACTIVE_COMPARATOR","Thymoglobulin is given as an intravenous infusion of 2.5 mg\u002Fkg\u002Fday over 2 days (days -2 and -1; total dose 5 mg\u002Fkg) via a central line through a 0.2 micron inline filter. Each dose will be infused over 6-8 hours. No test dose will be given. 30 minutes before Thymoglobulin, the patient should receive methylprednisolone 1mg\u002Fkg intravenously, 1g paracetamol PO and 10mg chlorphenamine IV. Patients should be monitored carefully and receive appropriate therapy for any infusion-related or anaphylactic reactions as per local policy.\n\nPatients will receive IV\u002FPO cyclosporine according to local policy to begin on day -1 maintaining a trough level of 100-200 µg\u002FL until day 90 before a subsequent taper in the absence of any active GvHD.\n\nMMF will be given IV\u002FPO according to local policy at a dose of 1g TDS to begin on day -1 and discontinued on day 35 without taper if there is no evidence of active GvHD. In adults weighing \\\u003C55kg, MMF should be given at a lower dose of 0.75g IV\u002FPO TDS.",[13,14,15],"Drug: Thymoglobulin","Drug: Cyclosporine","Drug: Mycophenolate Mofetil",{"label":17,"type":18,"description":19,"interventionNames":20},"Experimental arm (PTCy + Cyclosporine + MMF)","EXPERIMENTAL","Cyclophosphamide is given as an IV infusion of 50 mg\u002Fkg\u002Fday over 2 days (days 3 and 4; total dose 100 mg\u002Fkg) together with IV hydration and Mesna, as per local policy.\n\nPatients will receive IV\u002FPO cyclosporine according to local policy to begin on day 5 maintaining a trough level of 100-200 µg\u002FL until day 90 before a subsequent taper in the absence of active GvHD.\n\nMMF will be given IV\u002FPO according to local policy at a dose of 1g TDS to begin on day 5 and discontinued on day 35 without taper if there is no evidence of active GvHD. In adults weighing \\\u003C55kg, MMF should be given at a lower dose of 0.75g IV\u002FPO TDS.",[21,14,15],"Drug: Cyclophosphamide",{"label":23,"type":18,"description":24,"interventionNames":25},"Experimental arm (PTCy + Sirolimus + MMF)","Cyclophosphamide is given as an IV infusion of 50 mg\u002Fkg\u002Fday over 2 days (days 3 and 4; total dose 100 mg\u002Fkg) together with IV hydration and Mesna, as per local policy.\n\nSirolimus will be initially given PO as a loading dose of 6 mg on day 5 followed by 2 mg daily; doses will be adjusted to maintain a trough level (in whole blood) of 8 to 14 ng\u002FmL until day 60, thereafter 5-8 ng\u002FmL until day 90. In the absence of active GvHD, the dose of sirolimus will be tapered from day 90. We recommend that the daily maintenance dose of sirolimus is reduced empirically to 0.5-1mg daily with concomitant treatment with a triazole anti-fungal agent.\n\nMMF will be given IV\u002FO according to local policy at a dose of 1g TDS to begin on day 5 and discontinued on day 35 without taper if there is no evidence of active GvHD. In adults weighing \\\u003C55kg, MMF should be given at a lower dose of 0.75g IV\u002FPO TDS.",[21,26,15],"Drug: Sirolimus",[28,35,40,44,47],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Thymoglobulin","GVHD prophylaxis",[9],[34],"ATG",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Cyclophosphamide","Post transplant cyclophosphamide strategy for GVHD prophylaxis",[17,23],null,{"type":29,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Cyclosporine","immunosuppressant",[9,17],{"type":29,"name":45,"description":42,"armGroupLabels":46,"otherNames":39},"Sirolimus",[23],{"type":29,"name":48,"description":42,"armGroupLabels":49,"otherNames":50},"Mycophenolate Mofetil",[9,17,23],[51],"MMF",[53],{"name":54,"affiliation":55,"role":56},"Ronjon Professor Chakraverty","Oxford Cancer & Haematology Centre, The Churchill Hospital, Old Road - Headington, Oxford, OX3 7LE Email: ronjon.chakraverty@ndcls.ox.ac.uk","STUDY_DIRECTOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":39,"email":62},"MoTD Trial","CONTACT","0121 371 7859","MoTD@trials.bham.ac.uk",{"name":64,"role":60,"phone":65,"phoneExt":39,"email":66},"Andrea Dr Hodgkinson","0121 371 4365","A.Hodgkinson@bham.ac.uk",[68,85,94,103,112,124,133,142,151,157,166,172,181,190,199,208,217],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University Hospital of Wales","RECRUITING","Cardiff","Wales","CF14 4XW","United Kingdom","UK",{"type":77,"coordinates":78},"Point",[79,80],-3.18,51.48,{"lat":80,"lon":79},[83],{"name":84,"role":60,"phone":39,"phoneExt":39,"email":39},"Emma Kempshall",{"facility":86,"status":70,"city":87,"state":39,"zip":88,"country":74,"countryCode":75,"cosmosGeoPoint":89,"geoPoint":93,"contacts":39},"Queen Elizabeth Hospital","Birmingham","B15 2GW",{"type":77,"coordinates":90},[91,92],-1.89983,52.48142,{"lat":92,"lon":91},{"facility":95,"status":70,"city":96,"state":39,"zip":97,"country":74,"countryCode":75,"cosmosGeoPoint":98,"geoPoint":102,"contacts":39},"Bristol Haematology and Oncology Centre","Bristol","BS2 8ED",{"type":77,"coordinates":99},[100,101],-2.59665,51.45523,{"lat":101,"lon":100},{"facility":104,"status":70,"city":105,"state":39,"zip":106,"country":74,"countryCode":75,"cosmosGeoPoint":107,"geoPoint":111,"contacts":39},"Addenbrookes Hospital","Cambridge","CB2 0QQ",{"type":77,"coordinates":108},[109,110],0.11667,52.2,{"lat":110,"lon":109},{"facility":113,"status":70,"city":114,"state":39,"zip":115,"country":74,"countryCode":75,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Queen Elizabeth Hospital Glasgow","Glasgow","G51 4TF",{"type":77,"coordinates":117},[118,119],-4.25763,55.86515,{"lat":119,"lon":118},[122],{"name":123,"role":60,"phone":39,"phoneExt":39,"email":39},"Andrew Clark",{"facility":125,"status":70,"city":126,"state":39,"zip":127,"country":74,"countryCode":75,"cosmosGeoPoint":128,"geoPoint":132,"contacts":39},"St Jame's University Hospital","Leeds","LS9 7TF",{"type":77,"coordinates":129},[130,131],-1.54785,53.79648,{"lat":131,"lon":130},{"facility":134,"status":70,"city":135,"state":39,"zip":136,"country":74,"countryCode":75,"cosmosGeoPoint":137,"geoPoint":141,"contacts":39},"University College London Hospital","London","NW1 2BU",{"type":77,"coordinates":138},[139,140],-0.12574,51.50853,{"lat":140,"lon":139},{"facility":143,"status":70,"city":135,"state":39,"zip":144,"country":74,"countryCode":75,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"King's College Hospital","SE5 9RS",{"type":77,"coordinates":146},[139,140],{"lat":140,"lon":139},[149],{"name":150,"role":60,"phone":39,"phoneExt":39,"email":39},"Pramilla Krishnamurphy",{"facility":152,"status":70,"city":135,"state":39,"zip":153,"country":74,"countryCode":75,"cosmosGeoPoint":154,"geoPoint":156,"contacts":39},"Hammersmith Hospital","W12 0HS",{"type":77,"coordinates":155},[139,140],{"lat":140,"lon":139},{"facility":158,"status":70,"city":159,"state":39,"zip":160,"country":74,"countryCode":75,"cosmosGeoPoint":161,"geoPoint":165,"contacts":39},"Manchester Royal Infirmary","Manchester","M13 9WL",{"type":77,"coordinates":162},[163,164],-2.23743,53.48095,{"lat":164,"lon":163},{"facility":167,"status":70,"city":159,"state":39,"zip":168,"country":74,"countryCode":75,"cosmosGeoPoint":169,"geoPoint":171,"contacts":39},"The Christie","M20 3QH",{"type":77,"coordinates":170},[163,164],{"lat":164,"lon":163},{"facility":173,"status":70,"city":174,"state":39,"zip":175,"country":74,"countryCode":75,"cosmosGeoPoint":176,"geoPoint":180,"contacts":39},"Freeman Hospital","Newcastle upon Tyne","NE7 7DN",{"type":77,"coordinates":177},[178,179],-1.61396,54.97328,{"lat":179,"lon":178},{"facility":182,"status":70,"city":183,"state":39,"zip":184,"country":74,"countryCode":75,"cosmosGeoPoint":185,"geoPoint":189,"contacts":39},"Nottingham City Hospital","Nottingham","NG5 1PB",{"type":77,"coordinates":186},[187,188],-1.15047,52.9536,{"lat":188,"lon":187},{"facility":191,"status":70,"city":192,"state":39,"zip":193,"country":74,"countryCode":75,"cosmosGeoPoint":194,"geoPoint":198,"contacts":39},"Churchill Hospital","Oxford","OX3 7LE",{"type":77,"coordinates":195},[196,197],-1.25596,51.75222,{"lat":197,"lon":196},{"facility":200,"status":70,"city":201,"state":39,"zip":202,"country":74,"countryCode":75,"cosmosGeoPoint":203,"geoPoint":207,"contacts":39},"Derriford Hospital","Plymouth","PL6 8DH",{"type":77,"coordinates":204},[205,206],-4.14305,50.37153,{"lat":206,"lon":205},{"facility":209,"status":70,"city":210,"state":39,"zip":211,"country":74,"countryCode":75,"cosmosGeoPoint":212,"geoPoint":216,"contacts":39},"Royal Hallamshire Hospital","Sheffield","S102JF",{"type":77,"coordinates":213},[214,215],-1.4659,53.38297,{"lat":215,"lon":214},{"facility":218,"status":70,"city":219,"state":39,"zip":220,"country":74,"countryCode":75,"cosmosGeoPoint":221,"geoPoint":225,"contacts":39},"The Royal Marsden Hospital","Sutton","SM2 5PT",{"type":77,"coordinates":222},[223,224],-0.2,51.35,{"lat":224,"lon":223},{"type":227,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[229,232],{"name":230,"class":231},"The Jon Moulton Charity Trust","UNKNOWN",{"name":233,"class":231},"IMPACT (funded by NHS Blood & Transplant, Anthony Nolan and Leukaemia UK)","100430719","phase-2-methods-of-t-cell-depletion-trial-motd-100430719",false,"NCT04888741","Methods of T Cell Depletion Trial (MoTD)","A Multi-centre Phase II Trial of GVHD Prophylaxis Following Unrelated Donor Stem Cell Transplantation Comparing Thymoglobulin vs. Calcineurin Inhibitor or Sirolimus-based Post-transplant Cyclophosphamide","MoTD","Inclusion Criteria:\n\n* Availability of suitably matched unrelated donor (9\u002F10 or 10\u002F10)\n* Planned to receive one of the following RIC protocols:\n\n  * Fludarabine-Melphalan (Fludarabine 120-180mg\u002Fm2 IV; melphalan ≤ 150mg\u002Fm2 IV)\n  * BEAM or LEAM (carmustine 300mg\u002Fm2 IV or lomustine 200mg\u002Fm2 IV with: etoposide 800 mg\u002Fm2 IV; cytarabine 1600mg\u002Fm2 IV; melphalan 140mg\u002Fm2 IV)\n  * Fludarabine-Busulphan (Fludarabine 120-180mg\u002Fm2 IV; Busulphan ≤ 8mg\u002Fkg PO or 6.4mg\u002Fkg IV)\n  * Fludarabine- Treosulfan (Fludarabine 150mg\u002Fm2 IV; Treosulfan 30g\u002Fm2 IV)\n* Planned use of PBSCs for transplantation\n* Planned allo-SCT for one of the following haematological malignancies:\n\n  * AML in CR (patients enrolled onto the COSI trial are not eligible for this study)\n  * ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study)\n  * CMML \\\u003C10% blasts\n  * MDS \\\u003C10% blasts (patients enrolled onto the COSI trial are not eligible for this study)\n  * NHL in CR\u002FPR\n  * HL in CR\u002FPR\n  * MM in CR\u002FPR\n  * CLL in CR\u002FPR\n  * CML in 1st or 2nd chronic phase\n  * Myelofibrosis\n* Age 16-70 years\n* Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant\n\nExclusion Criteria:\n\n* Use of any method of graft manipulation (excluding storage of future DLI)\n* Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined\n* Known hypersensitivity to study drugs or history of hypersensitivity to rabbits\n* Pregnant or lactating women\n* Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period\n* Life expectancy \\\u003C8 weeks\n* Active HBV or HCV infection\n* Organ dysfunction defined as:\n\n  * LVEF \\\u003C45%\n  * GFR \\\u003C50ml\u002Fmin\n  * Bilirubin \\>50µmol\u002Fl\n  * AST\u002FALT\\>3 x ULN\n* Participation in COSI or ALL-RIC trials\n* Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC.\n* Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.","ALL","16 Years","70 Years",{"count":246,"type":247},400,"ESTIMATED","INTERVENTIONAL",[250],"PHASE2","A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.",[253,254,255,256,257,258,259,260,261],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndromes","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Multiple Myeloma","Chronic Myelogenous Leukemia","Myelofibrosis",[263,264,265,266,267,268,269,270,36,30,271,45,48],"GvHD","Allogeneic Stem Cell Transplant","AML","MDS","CML","CMML","NHL","HL","Cyclosporin","2026-04-29",{"date":274,"type":275},"2026-05-05","ACTUAL",{"date":277,"type":275},"2021-02-22",{"date":279,"type":247},"2027-08-23",{"name":5,"class":6},17]