Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

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