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

NCT ID: NCT04290000

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-27

Study Completion Date

2040-03-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma and Acute Lymphoblastic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hematological malignancies

hematological malignancies treated with CAR-T Cells

additional biological samples during CAR-T CELL treatment

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Département d'hématologie clinique

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sylvain LAMURE, MD

Role: CONTACT

0033467336733

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lamure a Sylvain, MD

Role: primary

0033467336733

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL19_0345

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma
NCT07024147 NOT_YET_RECRUITING PHASE1