Quality of Life-Guided Transfusion in Refractory MDS or AML (Q-TRANS)

Quality of Life-based Transfusion in Refractory MDS or AML Under Advanced Palliative Care and Supportive Treatment.

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; MDS; AML, Adult
• Intervention / Treatment: Other: Red blood cell transfusions based on EQ-5D-5L questionnaire

Detailed Description

This is a prospective, single-center, randomized interventional study conducted in patients with transfusion-dependent refractory MDS or AML receiving exclusive palliative care. Palliative Care

Patients are randomized to either a standard transfusion strategy based on hemoglobin thresholds or a quality-of-life-guided strategy in which red blood cell transfusions are triggered by a clinically significant deterioration in EQ-5D-5L score.

The study aims to evaluate whether a quality-of-life-guided transfusion strategy can safely reduce the number of red blood cell transfusions without negatively impacting patient-reported outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Cluzeau, Professor; Phone Number: 0492039025; Email: cluzeau.t@chu-nice.fr
• Study Contact Backup: Name: Lydia Cherfaoui; Phone Number: 0492039025; Email: cherfaoui.l@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice
    • Contact: Lydia Cherfaoui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Hemoglobin-Based Transfusion Strategy; 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
Experimental: Quality of Life-Guided Transfusion Strategy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Red Blood Cell Transfusions	Total number of red blood cell units transfused during the 2-month follow-up period.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (EQ-5D-5L)	Change in quality-of-life scores	from baseline to 1 month and 2 months.
Overall Survival	Survival status	from inclusion to 2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Thomas Cluzeau, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): February 9, 2028

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: palliative care; AML; MDS; Transfusion-dependent anemia; Chronic Transfusion-Dependent Anemia
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Anemia
• Other Study ID Numbers: 25-AOI-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No