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)

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Daratumumab

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