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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies in Montpellier University Hospital

Conditions
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Lymphoma and Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Other: additional biological samples during CAR-T CELL treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hematological malignancies<br>hematological malignancies treated with CAR-T Cells | Other: additional biological samples during CAR-T CELL treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient survival | assessment of the patient survival | up to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR T-Cell, lymphoma, Acute Lymphoblastic Leukemia