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)

Trial Title: 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)

NCT ID: NCT05749276

Condition: Adult Patients With Adverse Risk Acute Myeloblastic Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Daratumumab

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Continual Reassessment Method for MTD

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Darzalex
Description: DARZALEX® = Daratumumab. Solution for injection, 1800 mg/15 mL, single vial. Sub-cutaneous administration. - 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)
Arm group label: Darzalex

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

Criteria for 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 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

Gender: All

Minimum age: 60 Years

Maximum age: N/A

Healthy volunteers: No

Start date: May 2024

Completion date: January 2028

Lead sponsor:
Agency: Nantes University Hospital
Agency class: Other

Source: Nantes University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05749276