MDSQ-TRANSNCT07328191
Quality of Life-Guided Transfusion in Refractory MDS or AML
A study testing Red blood cell transfusions based on EQ-5D-5L questionnaire in people with MDS and AML, Adult, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDS, AML, Adult, Anemia
- What is being tested?
- Red blood cell transfusions based on EQ-5D-5L questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2026to 9 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Red blood cell transfusions based on EQ-5D-5L questionnaire
- Keywords
- palliative care, Chronic Transfusion-Dependent Anemia, Transfusion-dependent anemia, MDS, AML
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusions based on EQ-5D-5L questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin-Based Transfusion Strategy | No intervention | 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 |
| Quality of Life-Guided Transfusion Strategy | Experimental | 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 Receives: Other: Red blood cell transfusions based on EQ-5D-5L questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Red Blood Cell Transfusions
Total number of red blood cell units transfused during the 2-month follow-up period.
Measured: 2 months
Secondary outcomes (2)
Quality of Life (EQ-5D-5L)
Change in quality-of-life scores
Measured: from baseline to 1 month and 2 months.
Overall Survival
Survival status
Measured: from inclusion to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start9 Feb 2026
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: a standard hemoglobin-based red blood cell transfusion strategy or a quality-of-life-guided transfusion strategy based on EQ-5D-5L assessments.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Cluzeau, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328191
- Sponsor's protocol ID
- 25-AOI-02
- Acronym
- Q-TRANS
- Status last verified
- Feb 2026
- First submitted
- 26 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life-based Transfusion in Refractory MDS or AML Under Advanced Palliative Care and Supportive Treatment.
- ClinicalTrials.gov ID
- NCT07328191
- Acronym / sponsor ID
- Q-TRANS / 25-AOI-02
- Conditions
- MDS, AML, Adult, Anemia
- Keywords
- palliative care, Chronic Transfusion-Dependent Anemia, Transfusion-dependent anemia, MDS, AML
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Feb 2028 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to one of two parallel groups: a standard hemoglobin-based red blood cell transfusion strategy or a quality-of-life-guided transfusion strategy based on EQ-5D-5L assessments.
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin-Based Transfusion Strategy | No intervention | –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 |
| Quality of Life-Guided Transfusion Strategy | Experimental | Other: Red blood cell transfusions based on EQ-5D-5L questionnaireRed 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusions based on EQ-5D-5L questionnaireRed 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. | Other | Quality of Life-Guided Transfusion Strategy |
Primary outcome
Number of Red Blood Cell Transfusions
Time frame: 2 months
Total number of red blood cell units transfused during the 2-month follow-up period.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Cluzeau principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red blood cell transfusions based on EQ-5D-5L questionnaire in people with MDS and AML, Adult, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Cluzeau, Professor (0492039025, cluzeau.t@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Red Blood Cell Transfusions (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.