NCT04914091 Quality Of Life and Drug Use in Patients With CAR-T Cells
| NCT ID | NCT04914091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-03-31 |
| Primary Completion | 2033-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2021-03-31 with a primary completion date of 2033-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * In an institution * Under legal protection
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04914091 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04914091 currently recruiting?
Yes, NCT04914091 is actively recruiting participants. Contact the research team at catherine.rioufol@chu-lyon.fr for enrollment information.
Where is the NCT04914091 trial being conducted?
This trial is being conducted at Pierre-Bénite, France.
Who is sponsoring the NCT04914091 clinical trial?
NCT04914091 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 70 participants.