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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality of life assessment | Quality of life questionnaires |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12 months |
| The time to improvement in the PROMIS-Fatigue score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy
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| Name | Affiliation | Role |
|---|---|---|
| Alice Di Rocco | Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia | Bologna | Italy | ||||
| Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42285114 | Derived | Efficace F, Zinzani PL, Bonifazi F, Cutini I, Botto B, Chiappella A, Tisi MC, Bramanti S, Puglia S, Tartaglia F, Donzelli L, Farina M, Martino M, Gambella M, Ragaini S, Orciuolo E, Martelli M, Corradini P, Fazi P, Vignetti M, Rocco AD. Real-world patient-reported symptomatic adverse events and concordance with physician assessments after CAR T-cell therapy in patients with aggressive B-cell lymphomas: a prospective study. Lancet Haematol. 2026 Jun 12:S2352-3026(26)00128-6. doi: 10.1016/S2352-3026(26)00128-6. Online ahead of print. |
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To assess the time to improvement in the PROMIS-Fatigue score |
| 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 | 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 | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | After 2 years from date of registration |
| Brescia |
| Italy |
| AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale | Florence | Italy |
| Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti | Genova | Italy |
| Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia | Milan | 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 |
| 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 |
| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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