RecruitingNot ApplicableNCT07328191

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.

Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

52 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

MDS Anemia AML, Adult

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria17

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.
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 Criteria2

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.

Interventions

OTHERRed blood cell transfusions based on EQ-5D-5L questionnaire

Red blood cell transfusions are administered based on patient-reported quality-of-life assessments using the EQ-5D-5L questionnaire, collected weekly. A transfusion is performed when a deterioration of at least one level in any EQ-5D-5L dimension is observed.