Quality of Life-Guided Transfusion in Refractory MDS or AML

Recruiting now · Not applicable

Conditions studied: MDS, AML, Adult, Anemia

In brief

Patients with refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) in exclusive palliative care frequently receive red blood cell transfusions based on hemoglobin thresholds, despite limited evidence of clinical benefit in this setting. This prospective randomized study compares a standard hemoglobin-based transfusion strategy to a quality-of-life-guided strategy using the EQ-5D-5L questionnaire, with the aim of reducing transfusion burden while maintaining patient safety and quality of life.

Key facts

Study ID

NCT07328191

Run by

Centre Hospitalier Universitaire de Nice

People needed

52

Starts

2026-02-09

Expected to finish

2028-02-09

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• CHU de Nice — Nice, France (enrolling)

Full record on ClinicalTrials.gov

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