Testing Daratumumab With Chemotherapy in Older Adults With Acute Myeloid Leukemia
Tests daratumumab with chemotherapy in adults aged 60 and older with a hard-to-treat leukemia.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Nantes, FranceSee the site
- Phase
- Phase 1
Where in France
- CHU de NantesNantes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nantes University Hospital
- Trial code
- NCT05749276
- Record updated
- 25 June 2026
- Original description
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 prognosisRead full original descriptionShow less
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)
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
Inclusion: 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: 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; Patients with tuberculosis; Patients with documented active infection with COVID 19; Uncontrolled infection; Active or past infection with Hep B, C or HIV+; Hypersensitivity to any of the active ingredients or excipients; Patients with FLT3 ITD or TKD mutation; Patients with hereditary fructose intolerance (HFI); 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.