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

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.

Timeline

Start

2015-01

Primary completion

2025-07-30

Completion

2032-01

Publications

• Hunault M, Pautas C, Bertoli S, Dumas PY, Raffoux E, Hospital MA, Marchand T, Heiblig M, Chantepie S, Carre M, Peterlin P, Gallego-Hernanz MP, Lemasle E, Guieze R, Simand C, Turlure P, Huynh A, Leguay T, Devillier R, Quoc SN, Duployez N, Luquet I, Penther D, Celli-Lebras K, Mineur A, Raus N, Gardin C, Socie G, Cahn JY, Ifrah N, Vey N, de Latour RP, Delabesse E, Preudhomme C, Hamel JF, Pigneux A, Recher C, Dombret H. Intermediate-Dose Cytarabine as Postinduction AML Therapy. NEJM Evid. 2025 Jul;4(7):EVIDoa2400326. doi: 10.1056/EVIDoa2400326. Epub 2025 Jun 24.

Drugs

Indications