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2JF",{"type":55,"coordinates":1278},[1279,1280],-1.4659,53.38297,{"lat":1280,"lon":1279},[1283],{"name":1284,"role":38,"phone":29,"phoneExt":29,"email":1285},"Harpreet Knaur, MD","Harpreet.Kaur12@nhs.net",{"type":1287,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100472265","phase-3-mocravimod-as-adjunctive-and-maintenance-treatment-in-aml-patients-undergoing-allo-hct-100472265",false,"NCT05429632","Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT","Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT","MO-TRANS","Inclusion Criteria:\n\n* Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations\n* European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \\[CRi\\] is also allowable\n* Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft\n* Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5\n* Planned use of TAC-based GvHD prophylaxis\n* age ≥ 18 years and ≤ 75 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis\n* Diagnosis of macular edema during screening\n* Cardiac\u002Fpulmonary\u002Fhepatic\u002Frenal dysfunction\n* Hepatic dysfunction as defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN); or total bilirubin \\> 1.5 mg\u002FdL\n* Renal dysfunction with estimated creatinine clearance \\\u003C 45 mL\u002Fmin by the Cockcroft-Gault formula\n\n  * Diabetes mellitus\n  * History or presence of uveitis at screening\n  * History or diagnosis of macular edema","ALL","18 Years","75 Years",{"count":1300,"type":1301},366,"ESTIMATED","INTERVENTIONAL",[1304],"PHASE3","This is a multi-center, randomized, double-blinded, placebo controlled trial.",[1307],"Adult Acute Myeloid Leukemia","2026-06-18",{"date":1310,"type":1311},"2026-06-22","ACTUAL",{"date":1313,"type":1311},"2022-06-16",{"date":1315,"type":1301},"2029-11",{"name":5,"class":6},110]