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Recruiting NCT07328191

Quality of Life-Guided Transfusion in Refractory MDS or AML

No phase Interventional MDS AML, Adult Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Red blood cell transfusions based on EQ-5D-5L questionnaire.
Who it may be relevant to
Registry conditions: MDS, AML, Adult, Anemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Number of Red Blood Cell Transfusions [Time frame: 2 months]
Secondary outcome measures (2)
  • Quality of Life (EQ-5D-5L) [Time frame: from baseline to 1 month and 2 months.]
  • Overall Survival [Time frame: from inclusion to 2 months]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU de Nice — Nice

Identifiers

NCT: NCT07328191 · 25-AOI-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗