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)
Recruiting
Phase 1
Interventional Study
Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 60 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- Nantes University Hospital · Other
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About This Trial
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
Trial Locations
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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 pro…
Contacts