Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07328191

Quality of Life-Guided Transfusion in Refractory MDS or AML

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-02-12

52

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Quality of Life-Guided Transfusion in Refractory MDS or AML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Diagnosis of refractory MDS or AML, receiving palliative care only
  • Anemia with hemoglobin  8 g/dl at inclusion (or  9 g/dl if associated with cardiovascular disease)
  • Transfusion dependency, defined as requiring more than 2 red blood cell 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
Not Eligible

You will not qualify if you...

  • 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 impairing comprehension, consent, or ability to complete the EQ-5D-5L questionnaire
  • Active uncontrolled heart disease
  • Active hemolytic anemia
  • Recent major surgery
  • Life-threatening complications of MDS/AML
  • Presence of another serious or unstable disease making study participation risky
  • Vulnerable individuals
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

CHU de Nice

Nice, France, 06000

Actively Recruiting

Loading map...

Research Team

T

Thomas Cluzeau, Professor

CONTACT

L

Lydia Cherfaoui

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here