Phase IIb Placebo-controlled Study of Mocravimod as Adjunctive and Maintenance Treatment in AML Patients in Allo-HSCT

• Diagnosis of AML (excluding acute promyelocytic leukemia): European Leukemia Net (ELN) high risk AML in CR1, intermediate risk AML in CR1 if MRDpos, or AML of any risk in CR2.
• Planned allogeneic HSCT from fully matched sibling donor or unrelated donor using PBSC graft
• Planned use of protocol-suggested myeloablative conditioning regimen
• Planned use of CsA/MTX or TAC/MTX for GVHD prophylaxis
• age ≥ 18 years and ≤ 75 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Use of anti-thymocyte globulin (ATG), post-transplantation cyclophosphamide (PTCY), sirolimus, MMF, abatacept, or any other approved or non-approved medication other than MTX plus CsA or MTX plus TAC

• Diagnosis of macular edema during screening
• Cardiac/pulmonary/hepatic/renal dysfunction (conduction blockers, or quinidine)
  • 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