Quality-of-life–guided red blood cell transfusions for people with refractory MDS or AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, randomized interventional comparison at CHU de Nice that enrolls adults with transfusion-dependent refractory MDS or AML receiving exclusive palliative care. Participants are randomized to a standard transfusion approach driven by hemoglobin thresholds or to a quality-of-life-guided strategy in which transfusions are triggered by a clinically meaningful drop in EQ-5D-5L scores. The primary aim is to determine whether the QoL-guided approach can lower transfusion burden without worsening patient-reported outcomes or safety. The protocol requires documented transfusion dependence and the ability to reliably complete the EQ-5D-5L questionnaire.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 years and older.
* Diagnosis of refractory MDS or AML, receiving palliative care only.
* Anaemia with haemoglobin ≤ 8 g/dl at inclusion (or ≤ 9 g/dl if associated with cardiovascular disease).
* Transfusion dependency, defined as requiring more than 2 GR transfusions every 8 weeks.
* No vitamin B9, vitamin B12 or iron deficiency.
* Ability to understand and sign the informed consent form.
* Ability to comply with the schedule of visits and other protocol requirements.

Non inclusion Criteria:

* Previous malignant disease other than MDS or AML (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast).
* Active uncontrolled infection (hepatitis B or C, HIV).
* Use of G-CSF.
* Confirmed neurocognitive disorders (based on prior diagnosis or clinical assessment by the investigator) impairing comprehension, consent or the ability to reliably complete the EQ-5D-5L questionnaire.
* Active uncontrolled heart disease.
* Active haemolytic anaemia.
* Recent major surgery.
* Life-threatening complications of MDS/AML.
* Presence of another serious or unstable disease which, in the investigators' opinion, would make participation in the study inappropriate or risky for the patient's safety.
* Vulnerable individuals.

Exclusion Criteria:

* Immediate severe complications related to MDS/AML, such as uncontrolled bleeding, pneumonia with hypoxia or shock, or severe disseminated intravascular coagulopathy.
* Withdrawal of the patient's voluntary informed consent.

Where it's running

• CHU de Nice
  Nice, France Recruiting

Study contacts

• Principal investigator: Thomas Cluzeau — Centre Hospitalier Universitaire de Nice
• Study coordinator: Thomas Cluzeau, Professor
• Email: cluzeau.t@chu-nice.fr
• Phone: 0492039025

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.