Quality of Life-Guided Transfusion in Refractory MDS or AML

NCT ID: NCT07328191

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-02-01

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.

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.

Conditions

MDS; AML, Adult; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Cluzeau

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, , France

Countries

France

Central Contacts

Thomas Cluzeau, Professor

Role: CONTACT

cluzeau.t@chu-nice.fr

0492039025

Lydia Cherfaoui

Role: CONTACT

cherfaoui.l@chu-nice.fr

0492039025

Facility Contacts

Lydia Cherfaoui

Role: primary

Other Identifiers

25-AOI-02

Identifier Type: -

Identifier Source: org_study_id