Phase 2 Leukaemia Trial, Recruiting NCT05917405 Sponsor: Nantes University Hospital Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05917405
Recruiting Phase 2

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:

  • Adults aged 18 or older
  • People who have a type of blood cancer called AML (either newly diagnosed or developed from another condition) that is in complete remission at the time of transplant, or who have MDS/AML with a low level of abnormal cells in the bone marrow (5% or fewer)
  • People currently in their first or second round of treatment for their condition
  • People aged 60 or older, or people under 60 who have one or more other health conditions, making them suitable for a reduced-intensity treatment approach rather than a full-strength conditioning regimen
  • People who have a matching stem cell donor, either a family member or an unrelated person
  • People whose transplant will use stem cells collected from the blood (not bone marrow or cord blood)
  • People with a general health and activity level rated as reasonably functional (ECOG score of 0, 1, or 2) (confirm with trial site)
  • People who give their written agreement to take part
  • People who have previously had a stem cell transplant
  • People covered by the French social security system
  • Women who meet specific pregnancy prevention requirements, including using recommended contraception and having a negative pregnancy test before starting the study drug, or who are post-menopausal, or who have had a surgical procedure that means they cannot become pregnant

Who may not be able to join:

  • People with a specific subtype of leukaemia called pro-myelocytic leukaemia
  • People whose health allows them to have a full-strength (myeloablative) conditioning regimen
  • People whose donor is a half-matched family member, a partially matched unrelated donor, or whose transplant would use umbilical cord blood
  • Women who are pregnant or breastfeeding, or anyone unwilling to use required contraception
  • People who are HIV positive
  • People with active Hepatitis B or C infection
  • People whose heart pumping function is below 50% (confirm with trial site)
  • People with significantly reduced lung function (a specific lung capacity measure below 40%) (confirm with trial site)
  • People with an infection that is not currently under control
  • People with a type of anaemia involving the breakdown of red blood cells that is not currently under control
  • People whose kidneys are not filtering blood well enough (below a certain threshold on standard kidney function tests) (confirm with trial site)
  • People with significantly elevated liver function markers in their blood (confirm with trial site)
  • People who have or have had another cancer, unless it was a skin cancer, cervical cancer, or another solid cancer that was fully treated with no signs of disease for at least 2 years
  • People whose personal, family, social, or geographic circumstances may make it difficult to follow the trial schedule and requirements
  • People who have taken part in another interventional clinical trial in the past month, or who plan to take part in another interventional trial at the same time as this study

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 13 July 2026
Phase 2: approximately ~30% 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.

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
14 September 2023
Est. completion
14 September 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

To compare 2-year OS between patients with AML in complete remission receiving either a CloB2A2 or a FB2A2 RIC regimen for allo-SCT.

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: 13 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