Phase 1 Leukaemia Trial, Recruiting NCT05749276 Sponsor: Nantes University Hospital Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05749276
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 60 or older
  • People diagnosed with acute myeloid leukaemia (AML) that is considered high or intermediate risk (for newly diagnosed cases), or AML that has come back after previous treatment (for relapsed cases, regardless of risk level)
  • People whose general physical condition is reasonably good — able to carry out daily activities, with at most some limitations (confirm with trial site)
  • People whose doctors consider them well enough to receive intensive chemotherapy
  • People whose liver function tests are within acceptable ranges (specific blood test values will be checked by the trial site)
  • People whose kidneys are filtering blood at an adequate rate (specific values will be checked by the trial site)
  • People whose heart is pumping blood effectively enough to meet the trial's requirements (specific values will be checked by the trial site)
  • People who have given their written agreement to take part in the trial

Who may not be able to join:

  • People whose leukaemia has a specific genetic change called FLT3 ITD or TKD mutation
  • People with tuberculosis
  • People with an active, confirmed COVID-19 infection at the time of enrolment
  • People with a hereditary condition called fructose intolerance (HFI)
  • People with an infection that is not currently under control
  • People with a current or past infection with Hepatitis B, Hepatitis C, or HIV
  • People who are not part of the French social security system or covered as a beneficiary under it
  • People who are pregnant, or people who are able to have children but are unable to use an approved form of contraception during the trial and for at least 6 months after the last dose of the study drug Daratumumab
  • People who are breastfeeding
  • People under the age of 18
  • Adults who are under legal guardianship, curatorship, or a court-appointed protection order
  • People who have had a known allergic or sensitivity reaction to any of the ingredients in the study medications
  • People with serious heart conditions, including a heart attack in the 6 months before joining, unstable coronary artery disease, uncontrolled high blood pressure, or heart failure
  • People who are taking high-dose immune-suppressing medicines (such as steroids at 10mg prednisone or more per day, or equivalent) within 4 weeks before the first planned dose of the study treatment — with the exception of certain skin-applied steroid creams

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: MATHILDE HUNAULT, University Hospital, Angers

Phone: 02 40 08 32 71

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
6 February 2025
Est. completion
6 August 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

DLT

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov