Open-label, multicenter, randomized trial evaluating the contribution of CCNU in the treatment of acute myeloid leukemia (AML) in patients over 60 years of age with non-unfavorable cytogenetics and the feasibility of allogeneic transplantation with reduced conditioning in patients aged 60 to 65 years - LAM-SA 2007

INTERVENTION: Trade Name: Belustine Pharmaceutical Form: Capsule* INN or Proposed INN: Lomustine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- CONDITION: This study evaluates the benefit of Belustine in patients over 60 years of age with acute myeloid leukemia (AML) and unfavorable cytogenetics, and the feasibility of allogeneic transplantation with attenuated conditioning in subjects aged 60 to 65 years. ; MedDRA version: 9.1 Level: LLT Classification code 10000884 Term: Acute myeloid leukemia NOS PRIMARY OUTCOME: Main Objective: Improvement of overall survival by the addition of Belustine (CCNU) in induction and post-remission Primary end point(s): ‐Primary endpoint:; The primary endpoint is overall survival estimated by the Kaplan-Meier method for patients; - Primary secondary endpoints: - Complete remission rate; - 2-year disease-free survival estimated by the Kaplan-Meier method for all patients; - Mean duration of neutropenia and thrombocytopenia during the induction, consolidation, and maintenance phases: comparison of the two randomization arms; - Incidence of serious adverse events during the induction, consolidation, and maintenance phases for the entire treatment procedure; - 2-year cumulative incidence of relapse for all patients and for each group; - 2-year cumulative incidence of death from causes unrelated to the disease (toxic deaths) for all patients and for each group. - Molecular biology techniques will be used to screen for the following abnormalities: FLT3 ITD, NPM1 mutation, and CEBP a mutation; - Comparative impact on autonomy, cognitive function, and nutritional status will be assessed between each group at diagnosis and every 3 months throughout the study; Secondary Objectives: - Increased complete remission rate; - Improved disease-free survival (DFS); - Evaluation of toxicity and adverse effects related to CCNU; - Evaluation of the feasibility of reduced-conditioning allogeneic transplantation between 60 and 65 years of age; - Evaluation of prognostic factors; - Prospective oncogeriatric evaluation INCLUSION CRITERIA: - Adult patients over 60 years of age with previously untreated AML (patients with a history of tumors other than myeloproliferative or myelodysplastic syndromes, who have already received chemotherapy and/or radiotherapy for this diagnosis, are eligible for this study). - Presenting with unfavorable cytogenetics according to BGMT criteria. - Able to receive intensive chemotherapy (WHO score <3) and Sorror score <3 and having a life expectancy greater than one month. - Having given their informed consent, in writing, upon entry into the study (Law 88-1138 of 20/12/88); if this is not possible, a third-party attestation will be required. - Subject affiliated with or beneficiary of a social security scheme. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes