Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Registration Number
- NCT06026644
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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.
- Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
- Not able to read and understand local language.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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 QLQ-NHL-HG29 questionnaires After 2 years from date of registration To assess the time to improvement in the QLQ-NHL-HG29 questionnaires
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.
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.
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 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-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.
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.
Trial Locations
- Locations (13)
Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia
🇮🇹Bologna, Italy
AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale
🇮🇹Firenze, Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico
🇮🇹Palermo, Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
🇮🇹Pescara, Italy
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
🇮🇹Brescia, Italy
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
🇮🇹Genova, Italy
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
🇮🇹Milano, Italy
Aou Pisana - Uo Ematologia Universitaria
🇮🇹Pisa, Italy
Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
🇮🇹Roma, Italy
Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
🇮🇹Rozzano, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
🇮🇹Torino, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
🇮🇹Torino, Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
🇮🇹Vicenza, Italy