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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04290000
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 240
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma and Acute Lymphoblastic Leukemia	Other: additional biological samples during CAR-T CELL treatment

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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies in Montpellier University Hospital
• Actual Study Start Date: Mar 27, 2020
• Anticipated Primary Completion Date: Mar 27, 2025
• Anticipated Study Completion Date: Mar 27, 2040

Arms and Interventions

Arm

Intervention/Treatment

hematological malignancies hematological malignancies treated with CAR-T Cells

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 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. patient survival [up to 15 years]

   assessment of the patient survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département d'hématologie clinique	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04290000
• Other Study ID Numbers: RECHMPL19_0345
• First Posted: Feb 28, 2020
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: CAR T-Cell; lymphoma; Acute Lymphoblastic Leukemia
• Additional relevant MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hematologic Neoplasms

Study Results

No Results Posted as of Dec 22, 2021