Quality of life and medication use after CAR-T treatment for diffuse large B‑cell lymphoma
Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
Hospices Civils de Lyon · NCT04914091
This project will follow adults with DLBCL who receive CAR‑T therapy to see how the treatment affects their quality of life and the medicines they use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT04914091 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-comparative observational study of adults with diffuse large B‑cell lymphoma treated with commercial CAR‑T cells at Hospices Civils de Lyon. Participants will complete self-administered questionnaires and take part in semi-structured interviews to document quality of life, real-world drug consumption, and patient experience. Data collection occurs during routine hematology follow-up and through the clinical pharmacy unit to capture real-life care outside clinical trials. The goal is to provide complementary real-world evidence to the pivotal phase 1–2 trials that focused mainly on efficacy and safety.
Who should consider this trial
Good fit: Adults (≥18) with DLBCL scheduled for commercial CAR‑T treatment at Hospices Civils de Lyon who can provide consent and are not institutionalized or under legal protection are ideal candidates.
Not a fit: Patients treated in other centers or enrolled in other CAR‑T clinical trials, as well as institutionalized individuals or those under legal protection, are unlikely to be eligible or benefit from this study.
Why it matters
Potential benefit: If successful, the results could help improve supportive care, medication management, and policy decisions for patients receiving CAR‑T therapy.
How similar studies have performed: Pivotal CAR‑T trials showed clinical benefit in refractory DLBCL but generally did not collect detailed real-world quality-of-life or drug-use data, making this observational focus relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pierre-Bénite
- Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique — Pierre-Bénite, France (RECRUITING)
Study contacts
- Study coordinator: Catherine RIOUFOL, Pharm. D
- Email: catherine.rioufol@chu-lyon.fr
- Phone: 04 78 86 43 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells, CAR-T cells, Quality of life, drug use