An observational study in DLBCL - Diffuse Large B Cell Lymphoma, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Completed at 13 sites in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational
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.
Quality of life assessment
59 studies on the registry are indexed under Dendritic Cell Sarcoma, Interdigitating; 38 are open to participants now.
Browse Dendritic Cell Sarcoma, Interdigitating studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy
Exclusion Criteria:
Quality of life questionnaires
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
Time frame: at 12 months
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
Time frame: at 12 months
The time to improvement in the PROMIS-Fatigue score
To assess the time to improvement in the PROMIS-Fatigue score
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 2 years from date of registration
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Dendritic Cell Sarcoma, Interdigitating→
Gruppo Italiano Malattie EMatologiche dell'Adulto