Phase IIIII Randomized Study for Adults 18 to 60 Years Old with Acute Myeloid Leukemia Comparing Different Induction Chemotherapy Regimens, Consolidation Doses, and Graft Versus Host Disease Prevention After Stem Cell Transplant

What this Trial Is About

This trial studies adults aged 18 to 60 with Acute Myeloid Leukemia AML to improve overall survival using risk-adapted treatment strategies. It is an open-label, multicenter phase IIIII study evaluating different chemotherapy regimens during induction, consolidation, and, when applicable, stem cell transplantation. The study also assesses graft versus host disease GvHD prevention methods after transplant in intermediate-risk patients. Participants receive one of several chemotherapy induction regimens comparing daunorubicin and high-dose idarubicin combined with cytarabine. Consolidation treatment compares high-dose versus intermediate-dose cytarabine, sometimes combined with drugs like vosaroxin, dexamethasone, or venetoclax. For patients receiving allogeneic stem cell transplant, GvHD prophylaxis is studied comparing standard treatments such as methotrexate and cyclosporine with mycophenolic acid combinations. Treatment cycles and doses vary based on the patients risk and response. Throughout the study, participants undergo bone marrow evaluations, blood tests, and heart function assessments to monitor response and safety. Researchers track overall survival over three years, incidence of acute GvHD within 100 days post-transplant, and disease-free survival at 18 months. Participants provide informed consent and are monitored regularly during treatment and follow-up periods. The study completion is planned for January 2032.

Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR