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Recruiting Observational

Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies

NCT04290000 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2020-03-27
Last updated
2026-06-22

Condition(s) studied

Lymphoma and Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

additional biological samples during CAR-T CELL treatment

additional biological samples during CAR-T CELL treatment: Blood samples (additional tubes) and marrow (quantity taken in addition from the same aspiration) will be collected in addition to those useful for the follow up of the patients (progress of their disease after treatment with CAR-T Cells) at specific points in his treatment journey. The following samples will also be collected during Apheresis and at Car-T Cells reinjection : * Apheresis sampling * CAR-T Cells collected from bag rinsate In case of invasion, a skin biopsy will be made, 2 days and 8 days after the beginning of the CAR T Cell Treatment, during the patient's hospitalization and during a consultation visit in case of therapeutic progression or failure.

Study summary

Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukemia leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistence of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patient treated by CAR-T cell at the University Hospital of Montpellier Exclusion Criteria: * refusal to sign consent form * pregnant woman * major protected

Primary outcome measure(s)

  • Constitution of biological samples from patient treated with CAR T cells — up to 15 years
    The aim is only to collect biological samples. This collection will be used later to determine factors influencing efficacy of CAR-T cells treatments. Blood samples (additional tubes) and marrow (quantity taken in addition from the same aspiration) will be collected in addition to those useful for the follow up of the patients at specific points in his treatment and follow up. In case of invasion, a skin biopsy will be made, 2 days and 8 days after the beginning of the CAR T Cell Treatment, during the patient's hospitalization and during a consultation visit in case of therapeutic progression or failure.

Trial sites (1)

FacilityCityRegionStatus
Département d'hématologie clinique Montpellier France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04290000 on ClinicalTrials.gov ↗ ← All trials in France