Daratumumab with induction chemo in older adults with poor-risk AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial aiming to establish the maximum tolerated dose of daratumumab when combined with induction therapy using idarubicin and cytarabine or CPX-351 in patients aged 60 or older with adverse-risk AML. Eligible participants must be fit for intensive chemotherapy and have adequate liver, kidney, and heart function. The trial excludes patients with active infections, certain viral infections, or certain genetic mutations, and requires informed consent and French social security affiliation. The lead sponsor is Nantes University Hospital, with site activity at CHU de Nantes. Treatments will explore escalating doses of daratumumab in combination with standard chemotherapy to identify safety and tolerability in this high-risk population.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Nantes
  Nantes, France Recruiting

Study contacts

• Principal investigator: Mathilde Hunault — University Hospital, Angers
• Study coordinator: Pierre Peterlin
• Email: Pierre.PETERLIN@chu-nantes.fr
• Phone: 02 40 08 32 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.