Testing Mocravimod as Additional and Maintenance Oral Treatment for Adults with Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the efficacy and safety of mocravimod as an additional and maintenance treatment in adults with acute myeloid leukemia AML undergoing allogeneic hematopoietic cell transplantation HCT. This phase III, multicenter, randomized, double-blinded, placebo-controlled trial focuses on AML patients receiving stem cell transplants to assess relapse-free survival and overall survival outcomes. Participants will be assigned to one of three groups receiving either 3 mg or 1 mg of mocravimod orally once daily for 12 months, or a matching placebo orally once daily for the same duration. The study drugs are taken continuously over the one-year treatment period following transplantation, with the goal to evaluate mocravimod as a supportive therapy alongside standard care. During the study, participants will be monitored with regular clinical assessments, including evaluation of relapse-free survival at 12 months and overall survival at 24 months. Safety and efficacy will be closely observed through follow-up visits. The total participation duration spans at least one year of treatment plus extended survival monitoring, ensuring comprehensive data collection on the impact of mocravimod in this patient population.

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