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

Acute Leukemia Clinical Trial

— FLAM/FLAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693899
• Other study ID #: RC15_0374
• Status: Completed
• Start date: May 27, 2016
• Est. completion date: December 11, 2018

Study information

• Verified date: February 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 11, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Centre de Recherche en cancérologie Nantes-Angers - CRCNA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of plasma FLT3-L in adult patients with acute leukemia		up to three months