DARALAM
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)
Sponsor study identifier
interventional
12
1 country
1
Study Start
February 6, 2025
Actual (reported)Primary Completion
August 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2023
Actual (reported)March 1, 2023
Actual (reported)February 6, 2025
Actual (reported)August 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
DLT
Dose at which no toxic effect is observed, by determination of the LDT (Toxic Limit Dose). A TLD is defined by the occurrence of grade ≥ 3 daratumumab related toxicity that is not reversible after 7 days (except for haematological toxicity) or the absence of emergence from aplasia at D45 of induction (in the absence of treatment failure). Toxicity is assessed according to NCI-CTCAE version 5 criteria. The search for DLT is continued until D45 of induction.
DAY 45
response to the induction treatment
DAY 45
Assessment of myelotoxicity
Day 1
Overall survival (OS)
6 months
Event-free survival (EFS)
6 months
Relapse incidence
6 months
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)
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)
CHU de Nantes
Nantes, 44093, France
MATHILDE HUNAULT
University Hospital, Angers
MARC BERNARD
Rennes University Hospital
First Submitted
February 13, 2023
First Posted
March 1, 2023
Study Start
February 6, 2025
Actual (reported)Primary Completion
August 6, 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 6, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 25, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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