Quality-of-life–guided red blood cell transfusions for people with refractory MDS or AML
Quality of Life-based Transfusion in Refractory MDS or AML Under Advanced Palliative Care and Supportive Treatment.
We test whether using routine EQ-5D-5L quality-of-life scores to decide when to give red blood cell transfusions can safely reduce the number of transfusions for adults with refractory MDS or AML who are receiving only palliative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT07328191 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with refractory MDS or AML on exclusive palliative care who are transfusion-dependent (more than 2 packed red cell transfusions every 8 weeks), meet the hemoglobin entry criteria, have no correctable B9/B12/iron deficiency, and can reliably complete the EQ-5D-5L and consent process are ideal candidates.
Not a fit: Patients with active uncontrolled infections or heart disease, those receiving disease-modifying therapy or G-CSF, those with neurocognitive impairment preventing reliable questionnaire completion, or those who are not transfusion-dependent are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce the number of transfusions, lower transfusion-related risks and clinic visits, and preserve or improve patient quality of life during palliative care.
How similar studies have performed: Using quality-of-life questionnaires to trigger transfusions is a relatively novel strategy with limited randomized evidence, though symptom-guided or restrictive transfusion approaches have been explored in other patient groups with mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nice
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.