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

Plain Language Summary

Simplified for easier understanding

This study is testing a new approach to blood transfusions for patients with refractory blood cancer (MDS or AML) who are on palliative care only. Rather than giving transfusions based solely on lab values, doctors would base the decision on how the patient is feeling — focusing on quality of life. **You may be eligible if...** - You are 18 or older and have been diagnosed with refractory MDS (myelodysplastic syndrome) or AML (acute myeloid leukemia) - You are receiving palliative (comfort-focused) care only, not aiming for a cure - You have severe anemia (hemoglobin of 8 g/dL or below, or 9 g/dL or below if you have heart disease) - You need regular blood transfusions (more than 2 per 8 weeks) - You do not have vitamin B12, B9, or iron deficiency **You may NOT be eligible if...** - You have had another cancer besides MDS or AML (except certain skin or cervical cancers) - You have uncontrolled hepatitis B, C, or HIV infection - You have cognitive impairment that prevents you from completing quality-of-life questionnaires - You are on G-CSF (a white blood cell booster drug) - You have active uncontrolled heart disease or hemolytic anemia - You have had recent major surgery or have life-threatening cancer complications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.