Clinical trial NCT06026644: Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life
Official title: Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life: A Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy

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

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
timeFrame: at 12 months
Secondary outcomes:
measure: The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
timeFrame: at 12 months
measure: The time to improvement in the PROMIS-Fatigue score
timeFrame: After 2 years from date of registration
measure: The time to improvement in the EORTC QLQ-C30 questionnaires
timeFrame: After 2 years from date of registration
measure: The time to improvement in the QLQ-NHL-HG29 questionnaires
timeFrame: After 2 years from date of registration
measure: The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.
timeFrame: After 2 years from date of registration
measure: The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.
timeFrame: After 2 years from date of registration
measure: The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.
timeFrame: After 2 years from date of registration
measure: 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.
timeFrame: After + 10 day for infusion
measure: The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.
timeFrame: After 2 years from date of registration
measure: The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.
timeFrame: After 12 and 24 months from date of registration
measure: The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.
timeFrame: After 12 and 24 months from date of registration
measure: Factors predicting response to therapy and survival outcomes
timeFrame: After 2 years from date of registration
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
city: Firenze
country: Italy
facility: AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale
city: Genova
country: Italy
facility: Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
city: Milano
country: Italy
facility: Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
city: Palermo
country: Italy
facility: Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico
city: Pescara
country: Italy
facility: Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
city: Pisa
country: Italy
facility: Aou Pisana - Uo Ematologia Universitaria
city: Roma
country: Italy
facility: Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
city: Rozzano
country: Italy
facility: Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
city: Torino
country: Italy
facility: Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
city: Torino
country: Italy
facility: Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
city: Vicenza
country: Italy
facility: Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Study officials:
affiliation: Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
name: Alice Di Rocco
role: PRINCIPAL_INVESTIGATOR
References: