A phase III placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in AML patients undergoing allo-HCT (MO-TRANS Study)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 281

Inclusion Criteria

Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 2022 classification of AML and related precursor neoplasms, including therapy AML with myelodysplasia related gene mutations., Subjects with European LeukemiaNet (ELN) high risk or intermediate risk or AML in CR1, or AML of any risk in CR2. (Complete remission with incomplete count recovery [CRi] is also allowable). - Complete remission is defined as: < 5% marrow blasts by morphologic examination and no circulating peripheral blasts; absence of extramedullary disease; absolute neutrophil count = 1.0x109/L (1000/µL); platelet count = 100x109/L (100 000/µL) - CRi is defined as meeting all complete remission criteria except for residual absolute neutropenia < 1000/µL and/or thrombocytopenia <100 000/µL, Planned use of a related or unrelated donor or with no more than 1 antigen mismatch or planned use of a haploidentical donor, Life expectancy = 6 months at screening., Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Male or female, age = 18 years and = 75 years.

Exclusion Criteria

Planned use of anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis., Pulmonary dysfunction., Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. 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 x ULN, Renal dysfunction with creatinine clearance < 45 mL/min by the Cockcroft-Gault formula., History of stroke or intracranial hemorrhage within 1 year prior to screening., Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HCT., Planned use of serotherapy during conditioning, including ATG and alemtuzumab., Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection., Subjects having received prior allogeneic HCT or recipients of a solid organ transplant., Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (> 10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible., Require treatments for cardiac dysfunction, Subjects with acute promyelocytic leukemia., Blast crisis of chronic myeloid leukemia, Cardiac dysfunction

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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