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 Allografte

• Status: Recruiting
• Trial end date: 1969-12-31

Summary

This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Cyclosporine; Cyclosporins; Cytarabine; Daunorubicin; Dexamethasone; Idarubicin; Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Venetoclax