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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)

NCT05749276 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-18

No results posted yet for this study

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

Conditions

  • Adult Patients With Adverse Risk Acute Myeloblastic Leukemia

Interventions

DRUG

Darzalex

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)

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • MATHILDE HUNAULT · University Hospital, Angers

  • MARC BERNARD · CHU Rennes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2028-01-31
Completion
2028-01-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05749276 on ClinicalTrials.gov