Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
patient treated by CAR-T cell at the University Hospital of Montpellier
Disqualifiers
refusal to sign consent form
pregnant woman
major protected
Trial population
Patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
additional biological samples during CAR-T CELL treatment
Other interventionBlood 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: hematological malignancies1 intervention
Trial outcomes
Primary outcomes
1
Constitution of biological samples from patient treated with CAR T cells
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.
Time frame
up to 15 yearsSecondary outcomes
1
patient survival
assessment of the patient survival
Time frame
up to 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov