Skip to main content
OpenTrials
Recruiting

NCT Number: 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)

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Darzalex

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)

Primary outcomes

  1. DLT

    Time frame: DAY 45

    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.

Secondary outcomes

  1. response to the induction treatment

    Time frame: DAY 45

    calculation of the rate of complete remission (CR) with negative residual disease (CR MRD-), CR, CR with incomplete haematological recovery (CRi), MLFS (morphological leukemia free state), partial response (PR) or treatment failure according to the 2022 NLE definition between D30 and D45.

  2. Assessment of myelotoxicity

    Time frame: Day 1

    Neutrophil recovery time (>1.0 × 109/L) from D1 - Recovery time of platelets (>100 × 109/L) from D1

  3. Overall survival (OS)

    Time frame: 6 months

    time from D1 of induction to date of last contact or death

  4. Event-free survival (EFS)

    Time frame: 6 months

    time from D1 of induction to date of relapse, death or date of last

  5. Relapse incidence

    Time frame: 6 months

  6. Flow cytometry (FCM) investigation of myeloid-derived suppressor cells

    Time frame: Day 45

  7. Comparison of MDSC values in CMF

    Time frame: Day 45

  8. research on the level of CD38 expression on blasts

    Time frame: Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

PIERRE PETERLIN

CONTACT

[email protected]

02 40 08 32 71

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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)

Acronym: DARALAM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 1, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.