Acute Myeloid LeukaemiaNCT02844257
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
An observational study of Acute Myeloid Leukaemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Read more about this study
- Who is it for?
- Ages 15 to 83 years
- Conditions the study is for
- Acute Myeloid Leukaemia
- How many people
- 1,067 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 83 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute myeloid leukaemia (AML)
Who may be able to join
- Patient > 15 years old
- Newly diagnosed AML or post myelodysplastic syndrome (MDS)
Who cannot join
- Patients with M3 AML of French-American-British (FAB) classification (APL, Acute Promyelocytic Leukemia)
- World Health Organization (WHO) performance status >2; (ii)
- Left ventricular systolic ejection fraction below the normal range
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
- AST or ALT levels > 2.0 x upper limit of normal (ULN), except if AML-related
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, 69310
About this study
Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.
Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.
Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.
- Conditions
- Acute Myeloid Leukaemia
- Keywords
- Acute myeloid leukaemia, Transfusion dependency, Transfusion intensity, Prognosis, Chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause. Patients not known to have this event are censored on the date they were last examined
Measured: Date of last contact if alive (up to 11 months)
Secondary outcomes (2)
Complete remission (CR) rate
Response to induction therapy was assessed after one or two courses of chemotherapy (Between day 28 and day 35 of each course of chemotherapy). CR was defined according to standard criteria as less than 5 % blasts in bone marrow aspirates with evidence of maturation of cell lines and restoration of peripheral blood counts.
Measured: up to 11 months
Number of blood products for each type of administration
Transfusion of a single unit of packed red blood cell (PRBC) or one whole-blood-derived platelet concentrate (PC) or platelets collected by apheresis (PA).
Prophylactic transfusions were consistently given at morning platelet counts of <20×109/l and haemoglobin level <80 g/l. Patients requiring platelets were transfused with PC (PCs pooled from several units with 0.7 to 1×1011 platelets/10 kg of weight). Blood products were leukoreduced through discarding the buffy coat and administered through a standard blood filter but were not irradiated or routinely leukodepleted. Only patients planned to be allografted or autografted were transfused with irradiated transfusion products.
Measured: Duration of study (11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukaemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier THOMAS, MD-PhD, Principal investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844257
- Sponsor's protocol ID
- 69HCL16_0464
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
- ClinicalTrials.gov ID
- NCT02844257
- Acronym / sponsor ID
- 69HCL16_0464
- Conditions
- Acute Myeloid Leukaemia
- Keywords
- Acute myeloid leukaemia, Transfusion dependency, Transfusion intensity, Prognosis, Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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.
Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.
Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.
Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute myeloid leukaemia (AML)
Key inclusion criteria (2 listed)
- Patient > 15 years old
- Newly diagnosed AML or post myelodysplastic syndrome (MDS)
Key exclusion criteria (6 listed)
- Patients with M3 AML of French-American-British (FAB) classification (APL, Acute Promyelocytic Leukemia)
- World Health Organization (WHO) performance status >2; (ii)
- Left ventricular systolic ejection fraction below the normal range
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: Date of last contact if alive (up to 11 months)
Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause. Patients not known to have this event are censored on the date they were last examined
2 secondary outcomes
Complete remission (CR) rate
Time frame: up to 11 months
Number of blood products for each type of administration
Time frame: Duration of study (11 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Xavier THOMAS, MD-PhD principal investigator
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
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 Leukaemia, run by Hospices Civils de Lyon 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (OS) (time frame: Date of last contact if alive (up to 11 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 26 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.