B-Cell Lymphoma Clinical Trials

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Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials. The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies. This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Over 18 years old

• Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled

• Follow-up in the Hematology department of the Hospices Civils de Lyon

• Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator

• Having given his non-opposition to participate in the study.

Locations
Other Locations
France
Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique
RECRUITING
Pierre-bénite
Contact Information
Primary
Catherine RIOUFOL, Pharm. D
catherine.rioufol@chu-lyon.fr
04 78 86 43 70
Backup
Vérane SCHWIERTZ, Pharm. D
verane.schwiertz@chu-lyon.fr
04 78 86 43 59
Time Frame
Start Date: 2021-03-31
Estimated Completion Date: 2033-01-31
Participants
Target number of participants: 70
Treatments
Patients with diffuse large B-cell lymphoma treated with CART-cells
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov