Multicentric Phase 1 Study With Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine or CPX-351) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
To search for a Maximum Tolerated Dose (MTD) for the combination of daratumumab and induction chemotherapy with Idarubicin and cytarabine or CPX-351 in patients with Acute Myeloblastic Leukemia (AML) of poor prognosis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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%.
Locations
Other Locations
France
CHU de Nantes
RECRUITING
Nantes
Contact Information
Primary
PIERRE PETERLIN
Pierre.PETERLIN@chu-nantes.fr
02 40 08 32 71
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2028-08-06
Participants
Target number of participants: 12
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital