Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: additional biological samples during CAR-T CELL treatment.
- Who it may be relevant to
- Registry conditions: Lymphoma and Acute Lymphoblastic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies in Montpellier University Hospital
Overview
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.
Detailed description
Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukema 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 persistance 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.
Interventions
- Other 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
Primary outcome measures
- Constitution of biological samples from patient treated with CAR T cells [Time frame: up to 15 years]
Secondary outcome measures (1)
- patient survival [Time frame: up to 15 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Département d'hématologie clinique — Montpellier
Identifiers
NCT: NCT04290000 · RECHMPL19_0345