Acute Myeloid Leukemia Clinical Trial
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Full Description
The purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic cell transplantation (HCT).
Eligibility Criteria
Inclusion Criteria:
Diagnosis of AML according to the WHO 2022 classification (excluding acute promyelocytic leukemia) and European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1, or AML of any risk in CR2.
Planned allogeneic HCT from fully matched sibling donor or unrelated donor with no more than 1 antigen mismatch using PBSC graft
Planned use of myeloablative conditioning regimen that is expected to result in donor chimerism of > 90%
Planned use of CsA-based or TAC-based GvHD prophylaxis
age ≥ 18 years and ≤ 75 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Use of anti-thymocyte globulin (ATG), alemtuzumab, sirolimus, abatacept for GvHD prophylaxis
Diagnosis of macular edema during screening
Cardiac/pulmonary/hepatic/renal dysfunction
Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); or total bilirubin > 1.5 mg/dL
Renal dysfunction with estimated creatinine clearance < 60 mL/min by the Cockcroft-Gault formula
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There are 11 Locations for this study
Birmingham Alabama, 35233, United States
Los Angeles California, 90095, United States
Baltimore Maryland, 21201, United States
Stony Brook New York, 11794, United States
Cleveland Ohio, 44106, United States
Angers , , France
Lille , , France
Paris , , France
Villejuif , , France
Halle , , Germany
Jena , 07747, Germany
Jerusalem , , Israel
Tel Aviv , , Israel
Alessandria , 15121, Italy
Ascoli Piceno , 63100, Italy
Firenze , , Italy
Milano , , Italy
Barcelona , 08035, Spain
Barcelona , 8908, Spain
Barcelona , 8916, Spain
Granada , , Spain
Las Palmas De Gran Canaria , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Valencia , , Spain
Basel , , Switzerland
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