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

NCT02693899 | Completed

• 1 other identifier: RC15_0374
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Dosage of plasma FLT3-L in adult patients with acute leukemia

  up to three months

Interventions

Non Interventional study OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Centre de Recherche en cancérologie Nantes-Angers - CRCNA: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma (15 maximum plasma tubes of 9 mL per patient during follow-up)

Study Officials

• Pierre PETERLIN, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 29, 2016
• Study Start: May 27, 2016
• Primary Completion: February 6, 2018
• Study Completion: December 11, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)