Clinical trial · Observational
Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life
Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life: A Multicenter Prospective Observational Study
- 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)
This study will ultimately aim at providing the scientific community with patient-reported health status data that will contribute facilitate decision-makings. Short- and long-term HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing, symptom burden and daily functioning. This study will capture useful information on the impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned collection of PRO and physician-reported adverse events ad early time point will help to compare and integrate these two points of view in healthcare assessment.
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 |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Quality of life assessment
- description
- Quality of life questionnaires
Primary outcomes (1)
- measure
- The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
- timeFrame
- at 12 months
- description
- To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
Secondary outcomes (12)
- measure
- The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
- timeFrame
- at 12 months
- description
- To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma. * Scheduled to received CAR-T cell product. * Having a baseline PRO assessment. * Adult patients (≥ 18 years old). * Written informed consent provided. Exclusion Criteria: * Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment. * Not able to read and understand local language.
References
Publications (1)
- DERIVEDEfficace F, Zinzani PL, Bonifazi F, Cutini I, Botto B, Chiappella A, Tisi MC, Bramanti S, Puglia S, Tartaglia F, Donzelli L, Farina M, Martino M, Gambella M, Ragaini S, Orciuolo E, Martelli M, Corradini P, Fazi P, Vignetti M, Di Rocco A. Real-world patient-reported symptomatic adverse events and concordance with physician assessments after CAR T-cell therapy in patients with aggressive B-cell lymphomas: a prospective study. Lancet Haematol. 2026 Jul;13(7):e460-e470. doi: 10.1016/S2352-3026(26)00128-6. Epub 2026 Jun 12. PMID 42285114