Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life

Study Overview
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Brief Summary
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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.

Detailed Description
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Quality of life assessment

Official Title
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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

Conditions
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DLBCL - Diffuse Large B Cell Lymphoma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quality of life assessment<br>Quality of life questionnaires | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire | To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire | To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire | at 12 months | 
| The time to improvement in the PROMIS-Fatigue score | To assess the time to improvement in the PROMIS-Fatigue score | After 2 years from date of registration | 
| The time to improvement in the EORTC QLQ-C30 questionnaires | To assess the time to improvement in the EORTC QLQ-C30 questionnaires | After 2 years from date of registration | 
| The time to improvement in the QLQ-NHL-HG29 questionnaires | To assess the time to improvement in the QLQ-NHL-HG29 questionnaires | After 2 years from date of registration | 
| The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire. | To estimate the trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire. | After 2 years from date of registration | 
| The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire. | To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire. | After 2 years from date of registration | 
| The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire. | To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire. | After 2 years from date of registration | 
| Short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians. | To assess short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians | After + 10 day for infusion | 
| The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire. | To investigate the impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire. | After 2 years from date of registration | 
| The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire. | To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire. | After 12 and 24 months from date of registration | 
| The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire. | To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire. | After 12 and 24 months from date of registration | 
| Factors predicting response to therapy and survival outcomes | To identify pretreatment factors predicting response to therapy and survival outcomes. | After 2 years from date of registration |