Phase 4 Leukaemia Trial, Recruiting NCT05926063 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Leukaemia
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Phase 4 Leukaemia Trial, Recruiting

NCT05926063
Recruiting Phase 4

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 given voluntary written consent (or whose legal representative has given consent) before any screening takes place
  • People who are older than 16 years of age
  • People who have started intensive treatment within the past three days for one of the following blood cancer conditions: newly diagnosed acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS); OR a relapse of one of these conditions after being in remission for at least 6 months; OR preparation treatment (conditioning) before a stem cell transplant using a donor's cells; OR preparation treatment (conditioning) before a stem cell transplant using the patient's own cells
  • People whose immune cells (specifically a type called neutrophils) are expected to be at very low levels for at least 7 days
  • People who are expected to stay in hospital for at least 10 days

Who may not be able to join:

  • People who already have a confirmed or suspected infection at the time of enrolment
  • People who are already receiving broad-spectrum antibiotics (strong antibiotics that treat a wide range of infections)
  • People who are critically ill and require treatment in an Intensive Care Unit (ICU)
  • People with a SOFA score of 11 or higher — this is a medical severity score used by doctors to measure organ function (confirm with trial site)
  • People who have already had very low immune cell levels for more than 21 days before joining the trial
  • People who have previously been enrolled in this same study
  • People who are unable to provide written informed consent
  • People who have any other condition that, in the treating doctor's opinion, could affect their safety or ability to follow the study requirements
  • People who are receiving or have previously received other treatments that, in the treating doctor's opinion, could affect their safety or the reliability of the trial results

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 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Johan Maertens, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Phone: +32 16 34 48 77

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 4
Registry
ClinicalTrials.gov
Start date
26 February 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Absence of a serious medical complication (SMC) following 42 days after randomisation. SMC is defined as: Death; and/or ICU admission; and/or Septic shock requiring vasopressive therapy.

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: 23 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