Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.

Inclusion Criteria:age >= 18 yearsAML with a poor prognosis defined according to the criteria below:LAM First line: Age <60 years and unfavorable risk according to the 2017 ELN Age> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the ageECOG <= 2Patient eligible for intensive chemotherapyInformed consentLiver function tests: transaminases <3x normal, bilirubin <1.5X normalCreatinine clearance> 60ml / minLVEF> = 50%Exclusion Criteria:Patients with FLT3 ITD or TKD mutation eligible for FLT3 inhibitor therapyUncontrolled infectionHep B, C, HIV +History of diverticulosis / diverticulitisPatients at high risk of gastrointestinal perforationNo social security or any other schemePregnant women or patient unable to take contraception (pill, abstinence, IUD not allowed) in case of fertility. contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last SILTUXIMAB injection is not eligible for inclusion.Lactating womenMinorsAdults under guardianship, curatorship or legal protectionHypersensitivity to one of the active substances or to one of the excipients