Leukaemia Trial, Recruiting NCT06045819 Sponsor: University Hospital, Caen Condition: Leukaemia
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Leukaemia Trial, Recruiting

NCT06045819
Recruiting Not Applicable

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 who have been recently diagnosed with a type of blood cancer called AML (acute myeloid leukaemia) for the first time, with the diagnosis confirmed within 28 days of symptoms starting. A prior treatment to reduce white blood cell counts (such as hydroxyurea) is permitted.
  • People aged 75 or older who are not suitable for the standard intensive chemotherapy used for AML.
  • People aged between 60 and 74 who are not suitable for standard intensive chemotherapy, and who also have at least one of the following health conditions: reduced ability to carry out daily activities due to their illness; heart failure requiring treatment, reduced heart pumping function, or stable chest pain (angina); reduced lung function based on breathing tests; reduced kidney function within a specific range; liver damage (not caused by AML) with elevated bilirubin levels within a specific range; or another health condition that a doctor has determined makes standard chemotherapy unsuitable.
  • People whose condition makes them suitable for the current standard treatment for AML in this setting, which is a combination of two medicines called venetoclax and a hypomethylating agent (confirm with trial site).
  • People who have voluntarily signed and dated a consent form that has been approved by the relevant authorities.
  • People already taking part in another clinical study may still be eligible, provided that other study does not conflict with this one (confirm with trial site).

Who may not be able to join:

  • People whose blood white cell count is above 25 G/L at the time of enrolment.
  • People who have previously received any cancer treatment — including medicines, surgery, or radiotherapy — for AML, any other blood cancer, or any other cancer within the last two years.
  • People whose AML has spread to the brain or spinal fluid, or who have a specific subtype of AML called promyelocytic leukaemia (AML-M3).
  • People with a serious uncontrolled illness at the time of enrolment, such as an active infection requiring treatment, uncontrolled heart failure, unstable chest pain (angina), a heart rhythm problem, or a mental health condition or substance dependency that could affect the ability to follow the study requirements.
  • People who have a known serious allergic reaction to any of the medicines used in this trial.
  • People who have taken certain medicines or foods known to strongly affect how the body processes drugs — including grapefruit or Seville oranges — within the 7 days before starting treatment.

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 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Pierre-Marie Morice, PharmD, PhD, University Teaching Hospital of Caen

Phone: +33231272107

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
Not Applicable
Sponsor
University Hospital, Caen
Registry
ClinicalTrials.gov
Start date
8 April 2024
Est. completion
1 February 2025

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Comparison of mean plasma residual concentration of venetoclax

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: 16 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