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)

Nantes University Hospital (NUH)

Status and phase: Not yet enrolling; Phase 1

Conditions: Adult Patients With Adverse Risk Acute Myeloblastic Leukemia

Treatments: Drug: Darzalex

Study type: Interventional

Funder types: Other

Identifiers

NCT05749276

RC22_0372

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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 2022 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Darzalex

Experimental group

Description:

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)

Treatment:

Drug: Darzalex