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New treatment option for MDS
Official title Quality of Life-Guided Transfusion in Refractory MDS or AML
ClinicalTrials.gov ID: NCT07328191
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Immediate severe complications related to MDS/AML, such as uncontrolled bleeding, pneumonia with hypoxia or shock, or severe disseminated...
- Withdrawal of the patient's voluntary informed consent.
See the full eligibility 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nice, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.