NCT07328191Recruiting
Quality of Life-Guided Transfusion in Refractory MDS or AML
Quality of Life-based Transfusion in Refractory MDS or AML Under Advanced Palliative Care and Supportive Treatment.
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 26 Dec 2025
- Start date
- 9 Feb 2026
- Primary completion date
- 9 Feb 2027
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07328191
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 9 Feb 2026 to the primary completion date, 9 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Immediate severe complications related to MDS/AML, such as uncontrolled bleeding, pneumonia with hypoxia or shock, or severe disseminated intravascular coagulopathy.
Other
- Withdrawal of the patient's voluntary informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.