Acute LeukemiaFLAM/FLALNCT02693899
Prospective Study on the Feasibility of Plasma FLT3-Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated Intensively for Acute Leukemia
An observational study of Acute Leukemia, run by Nantes University Hospital at 1 site in France.
Trial summary
Despite advances in their classification and treatment, acute leukemia remain incurable disease for the majority of patients. It is necessary to identify new prognostic markers of survival and new therapeutic targets to improve prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Non Interventional study
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2016to 11 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults supported in the Clinical Hematology of the Nantes University Hospital between the beginning of the study and the end of 2017, for the diagnosis and treatment of myelogenous leukemia or acute lymphoblastic requiring intensive chemotherapy and possibly allogeneic haematopoietic stem cells.
Who may be able to join
- Acute myelogenous leukemia diagnosis or lymphoblastic
- Patient intensively treated
- Patients who agreed to participate in the study and having signed the consent biocollection
- Non-Inclusion Criteria:
- Patient aged under 18
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric, Biological, Uncontrolled, Prospective Study on the Feasibility of Plasma FLT3 Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated With Intensively for Acute Leukemia
Despite advances in their classification and treatment, acute leukemia remain incurable disease for the majority of patients. It is necessary to identify new prognostic markers of survival and new therapeutic targets to improve prognosis. Some studies have shown that Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an increase of this marker in the blood of patients responding to treatment. The aim of our prospective, non-interventional study is to measure the plasma levels of FLT3-L at different times of the management of patients with acute lymphoblastic leukemia but also myeloid. For this, analyzes of the samples collected in the usual care will be conducted to study the relationship between the plasma concentration of FLT3-L and outcomes. If there is any link, the FLT3-L could serve as a predictor of treatment response.
- Conditions
- Acute Leukemia
- Being tested
- Non Interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Interventional studyOther
The samples of the study were made in conjunction with blood tests done routinely, no additional venipuncture is provided by the study. Flt3L plasma concentration will be measured at different time monitoring of patients according to their pathology (Acute lymphoblastic leukemia or acute myeloid leukemia). The exact number of samples will vary for each patient depending on the course of the illness, it is expected up to 15 blood tubes 9mL.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of plasma FLT3-L in adult patients with acute leukemia
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start27 May 2016
- Primary completion6 Feb 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en cancérologie Nantes-Angers - CRCNA
- Responsible party
- Sponsor
- Investigators
- Pierre PETERLIN, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693899
- Sponsor's protocol ID
- RC15_0374
- Acronym
- FLAM/FLAL
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Biological, Uncontrolled, Prospective Study on the Feasibility of Plasma FLT3 Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated With Intensively for Acute Leukemia
- ClinicalTrials.gov ID
- NCT02693899
- Acronym / sponsor ID
- FLAM/FLAL / RC15_0374
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Centre de Recherche en cancérologie Nantes-Angers - CRCNA
- Study start
- 27 May 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 29 Feb 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.
Despite advances in their classification and treatment, acute leukemia remain incurable disease for the majority of patients. It is necessary to identify new prognostic markers of survival and new therapeutic targets to improve prognosis. Some studies have shown that Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an increase of this marker in the blood of patients responding to treatment. The aim of our prospective, non-interventional study is to measure the plasma levels of FLT3-L at different times of the management of patients with acute lymphoblastic leukemia but also myeloid. For this, analyzes of the samples collected in the usual care will be conducted to study the relationship between the plasma concentration of FLT3-L and outcomes. If there is any link, the FLT3-L could serve as a predictor of treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults supported in the Clinical Hematology of the Nantes University Hospital between the beginning of the study and the end of 2017, for the diagnosis and treatment of myelogenous leukemia or acute lymphoblastic requiring intensive chemotherapy and possibly allogeneic haematopoietic stem cells.
Key inclusion criteria (5 listed)
- Acute myelogenous leukemia diagnosis or lymphoblastic
- Patient intensively treated
- Patients who agreed to participate in the study and having signed the consent biocollection
- Patient aged under 18
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Non Interventional studyThe samples of the study were made in conjunction with blood tests done routinely, no additional venipuncture is provided by the study. Flt3L plasma concentration will be measured at different time monitoring of patients according to their pathology (Acute lymphoblastic leukemia or acute myeloid leukemia). The exact number of samples will vary for each patient depending on the course of the illness, it is expected up to 15 blood tubes 9mL. | Other | – |
Primary outcome
Dosage of plasma FLT3-L in adult patients with acute leukemia
Time frame: up to three 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 19 Feb 2019.
- 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. This study is not recruiting at the moment.
Pierre PETERLIN, Dr principal investigator
Nantes University Hospital
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 Leukemia, run by Nantes University Hospital 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 5 inclusion and 0 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 19 Feb 2019. 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?
Dosage of plasma FLT3-L in adult patients with acute leukemia (time frame: up to three 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 19 Feb 2019.