Quality of Life-Guided Transfusion in Refractory MDS or AML

NCT07328191 | Recruiting

• 1 other identifier: 25-AOI-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MDS; AML, Adult; Anemia

Keywords

palliative care; Chronic Transfusion-Dependent Anemia; Transfusion-dependent anemia; MDS; AML

Outcome Measures

Primary Outcomes (1)

• Number of Red Blood Cell Transfusions

  Total number of red blood cell units transfused during the 2-month follow-up period.

  2 months

Secondary Outcomes (2)

• Quality of Life (EQ-5D-5L)

  from baseline to 1 month and 2 months.

• Overall Survival

  from inclusion to 2 months

Study Arms (2)

Hemoglobin-Based Transfusion Strategy

NO INTERVENTION

Red blood cell transfusions are performed according to standard hemoglobin thresholds (Hb \<7 g/dL, or \<8 g/dL in patients with cardiovascular comorbidities). Standard of care arm

Quality of Life-Guided Transfusion Strategy

EXPERIMENTAL

Red blood cell transfusions are performed when a clinically significant deterioration (≥1 level decrease in at least one EQ-5D-5L domain compared to baseline) is observed

Other: Red blood cell transfusions based on EQ-5D-5L questionnaire

Interventions

Red blood cell transfusions based on EQ-5D-5L questionnaire OTHER

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.

Quality of Life-Guided Transfusion Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older.
• Diagnosis of refractory MDS or AML, receiving palliative care only.
• 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.

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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Thomas Cluzeau

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Cluzeau, Professor

CONTACT

0492039025; cluzeau.t@chu-nice.fr

Lydia Cherfaoui

CONTACT

0492039025; cherfaoui.l@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: a standard hemoglobin-based red blood cell transfusion strategy or a quality-of-life-guided transfusion strategy based on EQ-5D-5L assessments.

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 9, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): February 9, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)