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

Recruiting

• Conditions: Lymphoma and Acute Lymphoblastic Leukemia
• Interventions: Other: additional biological samples during CAR-T CELL treatment

• Registration Number: NCT04290000
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Study Start: 2020-03-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-03-27
• Study Completion: 2040-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hematological malignancies	additional biological samples during CAR-T CELL treatment	hematological malignancies treated with CAR-T Cells

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
patient survival	up to 15 years	assessment of the patient survival

Trial Locations

Locations (1)

Département d'hématologie clinique; 🇫🇷 Montpellier, France