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Recruiting NCT05749276

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)

Phase I Interventional Adult Patients With Adverse Risk Acute Myeloblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Darzalex.
Who it may be relevant to
Registry conditions: Adult Patients With Adverse Risk Acute Myeloblastic Leukemia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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

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)

Primary outcome measures

  • DLT [Time frame: DAY 45]
Secondary outcome measures (8)
  • response to the induction treatment [Time frame: DAY 45]
  • Assessment of myelotoxicity [Time frame: Day 1]
  • Overall survival (OS) [Time frame: 6 months]
  • Event-free survival (EFS) [Time frame: 6 months]
  • Relapse incidence [Time frame: 6 months]
  • Flow cytometry (FCM) investigation of myeloid-derived suppressor cells [Time frame: Day 45]
  • Comparison of MDSC values in CMF [Time frame: Day 45]
  • research on the level of CD38 expression on blasts [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Nantes — Nantes

Identifiers

NCT: NCT05749276 · RC22_0372

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗