Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

• Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy.
• Secondary Objectives:

• To assess the ability of lomustine to increase the CR rate.
• To assess the ability of lomustine to increase the event-free survival.
• To evaluate the toxicity and side-effects of lomustine.
• To evaluate the feasibility of reduced conditioning allogeneic transplantation *between 60 and 65 years old.
• To evaluate prognostic factors.
• To evaluate QOL in elderly.
• Study design: Parallel
• Study plan:

• Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1.
• Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine.
• Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months.
• Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).
• Number of subjects: 460

Inclusion criteria

• Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.
• Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
• Performance status and Sorror score < 3 .
• Signed and dated informed consent.

Exclusion criteria

• Acute promyelocytic leukemia.
• Patients with myeloproliferative syndromes prior to diagnosis of AML.
• Patients who previously had myelodysplastic syndrome.
• Positive serology for HIV.
• Patients with unfavourable cytogenetic
• Patients with an isolated medullary extra localization of their disease