LNH012: Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Quality of life assessment
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Quality of life assessment Quality of life questionnaires |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Scheduled to received CAR-T cell product.
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Having a baseline PRO assessment.
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Adult patients (≥ 18 years old).
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Written informed consent provided.
Exclusion Criteria:
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Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
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Not able to read and understand local language.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia | Bologna | Italy | ||
| 2 | Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia | Brescia | Italy | ||
| 3 | AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale | Firenze | Italy | ||
| 4 | Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti | Genova | Italy | ||
| 5 | Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia | Milano | Italy | ||
| 6 | Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico | Palermo | Italy | ||
| 7 | Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica | Pescara | Italy | ||
| 8 | Aou Pisana - Uo Ematologia Universitaria | Pisa | Italy | ||
| 9 | Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia | Roma | Italy | ||
| 10 | Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia | Rozzano | Italy | ||
| 11 | Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino | Torino | Italy | ||
| 12 | Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 | Torino | Italy | ||
| 13 | Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia | Vicenza | Italy |
Sponsors and Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
- Principal Investigator: Alice Di Rocco, Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GIMEMA _QoL _CAR-T