Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM) (DARALAM)
Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
About this trial
This is an interventional treatment trial for Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
Eligibility Criteria
Inclusion Criteria: Age >= 60 ans Poor prognosis AML defined according to the following criteria:1. For first-line AML:intermediate or unfavorable risk according to ELN 2017 2.for Relapsed AML:regardless of the ELN risk group ECOG <= 2 Patient eligible for intensive chemotherapy Who provide their written informed consent Liver workup: transaminases < 3x normal, bilirubin < 1.5 X normal Creatinine clearance > 60ml/mn LVEF >= 50%. Exclusion Criteria: Patients with FLT3 ITD or TKD mutation Patients with tuberculosis Patients with documented active infection with COVID 19 Patients with hereditary fructose intolerance (HFI) Uncontrolled infection Active or past infection with Hep B, C or HIV+ Not Affiliated with French social security system or no beneficiary from such system Pregnant women or patients who cannot take contraception ( contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 6 months after the last injection of DARATUMUMAB is not eligible for inclusion. Breastfeeding women Minors Adults under guardianship, curatorship or safeguard of justice Hypersensitivity to any of the active ingredients or excipients Patients with significant cardiovascular pathology including any of the following: myocardial infarction within 6 months prior to study entry, unstabilized coronary artery disease, uncontrolled hypertension, congestive heart failure. Patient with disease requiring systemic immunosuppressive therapy (such as high-dose steroids defined as ≥ 10mg prednisone or equivalent per day) within 4 weeks prior to the 1st scheduled dose of study treatment with the exception of dermocorticoids
Sites / Locations
Arms of the Study
Arm 1
Experimental
Darzalex
DARZALEX® Dose level 1 : 1800 mg Day 1 Dose level 2 : 1800 mg Day 1 and 8 (+/- 2 days) Dose level 3 : 1800 mg à Day 1, 8 (+/- 2 days) and D15 (+/- 2 days)