[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386629":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"King Faisal Specialist Hospital & Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Intervention","EXPERIMENTAL","Peripheral blood matched related donor HCT, using myeloablative conditioning regimen (IV Busulfan\u002FIV Fludarabine for AML, IV VP16\u002FTBI for ALL) HCT with cyclophosphamide, and oral tacrolimus (or another calcineurin inhibitor if intolerant for tacrolimus) for GVHD prophylaxis. Cyclophosphamide will be given at a dose of 50 mg\u002Fkg\u002Fday IV on Day +3 and Day +5 post stem cell infusion (only 2 doses).",[13],"Drug: Cyclophosphamide 50mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Standard of Care","ACTIVE_COMPARATOR","Peripheral blood matched related donor HCT, using myeloablative conditioning regimen (IV Busulfan\u002FIV Fludarabine for AML, IV VP16\u002FTBI for ALL) HCT with methotrexate, and oral tacrolimus (or another calcineurin inhibitor if intolerant for tacrolimus) for GVHD prophylaxis",[19],"Drug: Methotrexate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Cyclophosphamide 50mg","Cyclophosphamide as GVHD prophylaxis will be on day +3 and day +5",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Methotrexate","Methotrexate as GVHD prophylaxis will be on day +1, day +3, and day +6",[15],[32,36,38],{"name":33,"affiliation":34,"role":35},"Riad O El Fakih, MD","KFSH&RC","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":35},"Mahmoud D Aljurf, MD, MPH",{"name":39,"affiliation":34,"role":35},"Marwan Y Shaheen, MD",[41],{"name":33,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","+ 966114647272","34760","relfakih1@kfshrc.edu.sa",[47],{"facility":5,"status":48,"city":49,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Riyadh","Saudi Arabia","SA",{"type":53,"coordinates":54},"Point",[55,56],46.72185,24.68773,{"lat":56,"lon":55},[59],{"name":33,"role":42,"phone":26,"phoneExt":26,"email":26},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100386629","phase-3-comparing-post-transplant-cyclophosphamide-as-gvhd-prophylaxis-to-standard-of-care-for-acute-leukemia-patients-100386629",false,"NCT04314219","Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients","Comparing Post-Transplant Cyclophosphamide with Calcineurin Inhibitors As a GVHD Prophylaxis to Standard Care of Methotrexate and Calcineurin Inhibitors for Acute Leukemia Incorporating Patient Pharmacogenomics Profiling","PTCy-PMAT","Inclusion Criteria:\n\n* Patients with Acute Leukemias (AML, ALL) in morphologic complete remission with or without hematologic recovery\n* Patients must have a fully matched (8\u002F8) related donor willing to donate peripheral blood stem cells and must meet institutional criteria for donation\n* Planned Myeloablative conditioning regimen\n* Cardiac function: ejection fraction at rest ≥ 50% by MUGA or TTE\n* Estimated creatinine clearance greater than 50 mL\u002Fminute\n* Pulmonary function: DLCO ≥ 50% (adjusted for hemoglobin), and FVC and FEV1 ≥ 50%\n* Liver function: total bilirubin \\\u003C 2x the upper limit of normal (unless elevated bilirubin is attributed to Gilbert's Syndrome) and ALT\u002FAST \\\u003C 2.5x the upper normal limit\n* Signed informed consent\n\nExclusion Criteria:\n\n* Karnofsky or Lansky Performance Score \\\u003C 70%.\n* Active disease\n* Patients with uncontrolled bacterial, viral, or fungal infections\n* Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated\n* Patients seropositive for HIV-1 or -2\n* Patients seropositive for HTLV-I or -II\n* Patients with active Hepatitis B or C viral replication by PCR\n* Women who are pregnant (positive serum or urine βHCG) or breastfeeding\n* Females with childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation\n* History of uncontrolled autoimmune disease or on active treatment\n* Patients with prior malignancies, except resected non-melanoma skin cancer or treated cervical carcinoma in situ; cancer treated with curative intent ≥ 5 years previously will be allowed; cancer treated with curative intent \\\u003C 5 years previously will not be allowed.","ALL","14 Years","65 Years",{"count":74,"type":75},264,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","This randomized clinical trial will evaluate two approaches of GvHD prophylaxis; the standard of care GVHD prophylaxis regimen (methotrexate\u002Fcalcineurin inhibitors) and post-transplant cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.",[81,82],"Acute Lymphoblastic Leukemia (ALL) in Complete Remission","Acute Myeloid Leukemia (AML) in Remission",[84,85,86,87],"Sibling Donor Transplant","Allogeneic hematopoietic cell transplantation","GvHD Prophylaxis","Myeloablative regimen","2025-03-12",{"date":90,"type":91},"2025-03-13","ACTUAL",{"date":93,"type":91},"2021-08-15",{"date":95,"type":75},"2026-12",{"name":5,"class":6},1]