Phase 3 Leukaemia Trial, Recruiting NCT06083129 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT06083129
Recruiting Phase 3

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 50 to 70 years old.
  • People aged 50 to 55 who have been assessed as not fit enough for the most intensive type of stem cell transplant preparation (based on a health scoring system called SORROR, with a score of 2 or higher).
  • People diagnosed with a blood cancer called AML (acute myeloid leukaemia) that requires a stem cell transplant from a donor, where the disease is currently in remission (no cancer cells detectable), or people diagnosed with a bone marrow condition called MDS (myelodysplastic syndrome) that requires a donor stem cell transplant and meets certain severity thresholds (confirm with trial site).
  • People who do not have a closely matched family member available as a stem cell donor.
  • People who have an identified closely matched unrelated donor (matched at 10 out of 10 points on a tissue-matching scale).
  • People whose general health meets standard requirements for a stem cell transplant, including: being reasonably functional day-to-day (ECOG score of 2 or less); having no severe uncontrolled infection; having adequate heart function (pumping at least 50% efficiency); having adequate lung function (above a certain breathing test threshold); and having adequately functioning liver and kidneys (confirm specific values with trial site).
  • People who have health insurance coverage.
  • People who have read and signed a written consent form agreeing to take part.
  • People who are willing to use an approved contraception method for the full duration of the trial — this applies to women of childbearing age (including options such as hormonal contraception or an intrauterine device) and to men (including condoms or abstinence, where abstinence reflects their usual lifestyle).

Who may not be able to join:

  • People who have had another cancer in the past 5 years (except certain very early-stage or minor skin or cervical cancers).
  • People with an active, uncontrolled infection.
  • People who test positive for HIV, HTLV-1, or who have active hepatitis B or C.
  • People who have received a yellow fever vaccine or any other live virus vaccine within 2 months before the transplant.
  • People with heart failure of a certain severity, or whose heart pumping function is below 50%.
  • People whose lung function falls at or below a certain breathing test threshold.
  • People who already have a bladder condition involving bleeding (acute haemorrhagic cystitis).
  • People whose kidneys are not functioning well enough (below a certain filtration rate threshold).
  • People who are pregnant or breastfeeding.
  • People with a serious medical or psychiatric condition that would prevent them from safely undergoing the transplant or from understanding the trial.
  • People receiving a particular type of government-funded medical assistance (state medical aid, as defined in the trial country).
  • People who are under a legal protection order, guardianship, or curatorship.
  • People who have a known allergy to any of the main trial medications, including the anti-rejection medicines or any other drugs planned for use in the trial (confirm specific medications with trial site).
  • People who are currently participating in another interventional clinical trial.

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 9 July 2026
Phase 3: approximately ~65% 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

Phone: +33142385073

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 3
Registry
ClinicalTrials.gov
Start date
28 November 2023
Est. completion
28 November 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Incidence of grade II-IV acute Graft Versus Host Disease (GVHD) according to the Mount Sinai Acute GVHD International Consortium (MAGIC) classification

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: 9 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