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)

NCT ID: NCT05749276

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2028-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Darzalex

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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 provide their written informed consent
• Liver workup: transaminases < 3x normal, bilirubin < 1.5 X normal
• Creatinine clearance > 60ml/mn
• LVEF >= 50%.

Exclusion Criteria

• Patients with FLT3 ITD or TKD mutation
• Patients with tuberculosis
• Patients with documented active infection with COVID 19
• Patients with hereditary fructose intolerance (HFI)
• Uncontrolled infection
• Active or past infection with Hep B, C or HIV+
• 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
• Hypersensitivity to any of the active ingredients or excipients
• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MATHILDE HUNAULT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

MARC BERNARD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Central Contacts

PIERRE PETERLIN

Role: CONTACT

Pierre.PETERLIN@chu-nantes.fr

02 40 08 32 71

Other Identifiers

RC22_0372

Identifier Type: -

Identifier Source: org_study_id