[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-all-in-complete-remission\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-all-in-complete-remission":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":42,"leadSponsor":44,"locationsCount":5},"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":21,"type":22},264,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Acute Lymphoblastic Leukemia (ALL) in Complete Remission","Acute Myeloid Leukemia (AML) in Remission",[31,32,33,34],"Sibling Donor Transplant","Allogeneic hematopoietic cell transplantation","GvHD Prophylaxis","Myeloablative regimen","RECRUITING","2025-03-12",{"date":38,"type":39},"2025-03-13","ACTUAL",{"date":41,"type":39},"2021-08-15",{"date":43,"type":22},"2026-12",{"name":45,"class":46},"King Faisal Specialist Hospital & Research Center","OTHER"]