NCT06026644Completed
Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 170 (actual)
- First submitted
- 5 Jul 2023
- Start date
- 29 Jun 2022
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06026644
What you commit to
- Study type: Observational
- Participants enrolled: 170
- From 29 Jun 2022 to the primary completion date, 15 Feb 2024
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
Other
- Not able to read and understand local language.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| Aou Pisana - Uo Ematologia Universitaria Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.