Clinical trial · Observational
Quality Of Life and Drug Use in Patients With CAR-T Cells
Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Semi-structured interviews and self-administered questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with diffuse large B-cell lymphoma treated with CART-cells
- interventionNames
- Other: Semi-structured interviews and self-administered questionnaires
Primary outcomes (1)
- measure
- Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire
- timeFrame
- Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells
- description
- Self-administered questionnaire EORTC-QLQ C30 (European Organisation for Research and Treatment of Cancer), developed to assess the quality of life of cancer patients, with 30 items. Score ranges from 0 (the worse) to 100 (the best).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available