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

Gruppo Italiano Malattie EMatologiche dell'Adulto13 sites in 1 country170 target enrollmentJune 29, 2022

ConditionsDLBCL - Diffuse Large B Cell Lymphoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Enrollment: 170
Locations: 13
Primary Endpoint: The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Quality of life assessment

Registry

clinicaltrials.gov

Start Date

June 29, 2022

End Date

April 15, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire

Time Frame: at 12 months

To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire

Secondary Outcomes

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)
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 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(After 2 years from date of registration)
The time to improvement in the QLQ-NHL-HG29 questionnaires(After 2 years from date of registration)
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)
Factors predicting response to therapy and survival outcomes(After 2 years from date of registration)
The time to improvement in the EORTC QLQ-C30 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.(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.(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.(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.(After 12 and 24 months from date of registration)