DLBCL - Diffuse Large B Cell Lymphoma
Conditions
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
Interventions
None listed
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire | at 12 months | To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire | at 12 months | To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire |
| The time to improvement in the PROMIS-Fatigue score | After 2 years from date of registration | To assess the time to improvement in the PROMIS-Fatigue score |
| The time to improvement in the EORTC QLQ-C30 questionnaires | After 2 years from date of registration | To assess the time to improvement in the EORTC QLQ-C30 questionnaires |
| The time to improvement in the QLQ-NHL-HG29 questionnaires | After 2 years from date of registration | To assess the time to improvement in the QLQ-NHL-HG29 questionnaires |
| The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire. | After 2 years from date of registration | To estimate the trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire. |
| 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 | To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire. |
| 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 | To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire. |
| 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 | 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 |
| 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 | To investigate the impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire. |
| 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 | 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. |
| 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 | 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. |
| Factors predicting response to therapy and survival outcomes | After 2 years from date of registration | To identify pretreatment factors predicting response to therapy and survival outcomes. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORAlice Di Rocco
Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
Outcome results
None listed