CompletedNot Applicable

Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life

Italy170 participantsStarted 2022-06-29

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study tracked real-world quality of life in DLBCL patients treated with CAR-T cell therapy — can you tell me what the fatigue data showed, and whether patients typically saw meaningful improvement or worsening after treatment?
2Since this was an observational study measuring how patients actually felt during CAR-T therapy in everyday clinical settings rather than a controlled trial, how do its findings compare to what I might experience based on my specific situation?
3The trial is now completed — has the data been published or presented anywhere, and can we review the quality-of-life results together so I understand what the fatigue and wellbeing experience looks like for real patients going through CAR-T?
4CAR-T cell therapy is an intensive treatment — based on what this study found about how patients coped day-to-day, do you think my current health and support situation would allow me to manage that kind of treatment demands?
5Are there standard treatment options I should consider before or instead of CAR-T therapy, and how do the quality-of-life trade-offs compare based on what studies like this one have reported?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire

Timeframe: at 12 months

Trial details

NCT IDNCT06026644

SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-15

View on ClinicalTrials.gov More DLBCL - Diffuse Large B Cell Lymphoma trials