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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 (FLAM/FLAL)

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ClinicalTrials.gov Identifier: NCT02693899
Recruitment Status : Completed
First Posted : February 29, 2016
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Centre de Recherche en cancérologie Nantes-Angers - CRCNA
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Acute Leukemia Other: Non Interventional study

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 27, 2016
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia


Intervention Details:
  • Other: Non Interventional study
    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.


Primary Outcome Measures :
  1. Dosage of plasma FLT3-L in adult patients with acute leukemia [ Time Frame: up to three months ]

Biospecimen Retention:   Samples Without DNA
Plasma (15 maximum plasma tubes of 9 mL per patient during follow-up)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693899


Locations
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France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Centre de Recherche en cancérologie Nantes-Angers - CRCNA
Investigators
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Principal Investigator: Pierre PETERLIN, Dr Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02693899     History of Changes
Other Study ID Numbers: RC15_0374
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Flt3 ligand protein
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents