Acute Myeloid LeukemiaERAPHNCT06786897
Expectations of Patients in Palliative Situation
An observational study of Acute Myeloid Leukemia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
To date, there is a lack of data about the benefit of blood cell transfusions for patients diagnosed of a hematologic malignancy who are not eligible for curative treatments. Furthermore, there is no clear guideline about how to transfuse these patients and when the blood cell transfusions should be stopped. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2025to 1 Jan 2028
- Phase
- Observational
- 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
Study population: Patients will be recruted in palliative department of the hospital
Who may be able to join
- Patients aged 18 years or more AND
- Diagnosed of an intermediate or high-risk acute leukemia and not eligible for allogenic stem cell transplantation Or
- Diagnosed of a high-risk myelodisplasic syndrome and not eligible for allogenic stem cell transplantation Or
- Diagnosed of an intermediate or high-risk myelofibrosis and not eligible for allogenic stem cell transplantation Or
- Diagnosed of a chronic myeloid leukemia in blast crisis phase and not eligible for allogenic stem cell transplantation Or
- Relapsing after allogenic stem cell transplantation and not eligible for a second allogenic stem cell transplantation
Who cannot join
- Patients who can't read
- Patients who can't write
- Patients who can't express their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expectations of Patients in Palliative Situation and Their Caregivers Concerning Blood Cell Transfusions in Haematology Department
To date, there is a lack of data about the benefit of blood cell transfusions for patients diagnosed of a hematologic malignancy who are not eligible for curative treatments. Furthermore, there is no clear guideline about how to transfuse these patients and when the blood cell transfusions should be stopped.
Allogenic stem cell transplantation is nowadays the only curative treatment for patients with high-risk myeloid neoplasms. Knowing that the median age at diagnostic for acute myeloid leukemia is 68 years and this incidence increases after 65 years, a lot of patients won't be eligible for allogenic stem cell transplantation.
Read more
Besides, patients with haematologic malignancies are prone to cytopenias, due to their pathology and the treatments used to limit its progression. A study estimate that these patients need a median of 4 blood cell units per month, and it is known that repeated transfusions are associated with an increased risk of dying in hospital.
Finally, it is estimate that there was a lack of 20 000 blood cell units in France in 2022.
It therefore seems essential to find ways to optimize blood transfusion prescriptions in this population of patients who won't be eligible for curative treatments, with the main idea of maintaining or even improving their quality of life.
The investigators will study the expectations of patients in palliative situation, paramedics and medical staff concerning blood cell transfusions, by asking them if whether or not they believe that the transfusion planed to be administer will benefit the patient. To do this, investigators will distribute questionnaires before each blood cell transfusions to patients who will be included, to the paramedic who administered the transfusion and to the physician who prescribed the transfusion.
It is to investigators knowledge the first study to compare the expectations of patients in palliative situation, paramedics and medical staff concerning blood cell transfusions in hematology department, and follow the evolution of these expectations prospectively.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Questionnaire and Physical Exam
- Keywords
- haematology, palliative situation
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
Questionnaires evaluating the expectations of patients in palliative situation, of paramedics and medical staff, concerning blood cell transfusions.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient in palliative situation Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the benefit of blood cell transfusion before each blood cell transfusion
Evaluate the concordance for the perceptions of the benefit of blood cell transfusions in a palliative situation in hematology department between patients, paramedical and medical staff
Measured: up to 52 weeks
Secondary outcomes (1)
Number of days before death
Define the median number of days before death, from which patients believe they no longer benefit from blood transfusions
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start31 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786897
- Sponsor's protocol ID
- RECHMPL24_0289
- Other IDs
- 2024-A02148-39
- Acronym
- ERAPH
- Status last verified
- Jun 2026
- First submitted
- 10 Jan 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectations of Patients in Palliative Situation and Their Caregivers Concerning Blood Cell Transfusions in Haematology Department
- ClinicalTrials.gov ID
- NCT06786897
- Acronym / sponsor ID
- ERAPH / RECHMPL24_0289
- Conditions
- Acute Myeloid Leukemia
- Keywords
- haematology, palliative situation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 Jan 2025 (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.
To date, there is a lack of data about the benefit of blood cell transfusions for patients diagnosed of a hematologic malignancy who are not eligible for curative treatments. Furthermore, there is no clear guideline about how to transfuse these patients and when the blood cell transfusions should be stopped.
Allogenic stem cell transplantation is nowadays the only curative treatment for patients with high-risk myeloid neoplasms. Knowing that the median age at diagnostic for acute myeloid leukemia is 68 years and this incidence increases after 65 years, a lot of patients won't be eligible for allogenic stem cell transplantation.
Besides, patients with haematologic malignancies are prone to cytopenias, due to their pathology and the treatments used to limit its progression. A study estimate that these patients need a median of 4 blood cell units per month, and it is known that repeated transfusions are associated with an increased risk of dying in hospital.
Finally, it is estimate that there was a lack of 20 000 blood cell units in France in 2022.
It therefore seems essential to find ways to optimize blood transfusion prescriptions in this population of patients who won't be eligible for curative treatments, with the main idea of maintaining or even improving their quality of life.
The investigators will study the expectations of patients in palliative situation, paramedics and medical staff concerning blood cell transfusions, by asking them if whether or not they believe that the transfusion planed to be administer will benefit the patient. To do this, investigators will distribute questionnaires before each blood cell transfusions to patients who will be included, to the paramedic who administered the transfusion and to the physician who prescribed the transfusion.
It is to investigators knowledge the first study to compare the expectations of patients in palliative situation, paramedics and medical staff concerning blood cell transfusions in hematology department, and follow the evolution of these expectations prospectively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Questionnaire and Physical ExamPatient in palliative situation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruted in palliative department of the hospital
Key inclusion criteria (6 listed)
- Patients aged 18 years or more AND
- Diagnosed of an intermediate or high-risk acute leukemia and not eligible for allogenic stem cell transplantation Or
- Diagnosed of a high-risk myelodisplasic syndrome and not eligible for allogenic stem cell transplantation Or
- Diagnosed of an intermediate or high-risk myelofibrosis and not eligible for allogenic stem cell transplantation Or
- Diagnosed of a chronic myeloid leukemia in blast crisis phase and not eligible for allogenic stem cell transplantation Or
Key exclusion criteria (3 listed)
- Patients who can't read
- Patients who can't write
- Patients who can't express their 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 |
|---|---|---|
| Questionnaire and Physical ExamQuestionnaires evaluating the expectations of patients in palliative situation, of paramedics and medical staff, concerning blood cell transfusions. | Other | Patient |
Primary outcome
Evaluation of the benefit of blood cell transfusion before each blood cell transfusion
Time frame: up to 52 weeks
Evaluate the concordance for the perceptions of the benefit of blood cell transfusions in a palliative situation in hematology department between patients, paramedical and medical staff
1 secondary outcome
Number of days before death
Time frame: through study completion, an average of 1 year
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 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Publication of the results
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by University Hospital, Montpellier 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the benefit of blood cell transfusion before each blood cell transfusion (time frame: up to 52 weeks). 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 22 Jun 2026.