Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Observational, single-center, tissue-based cohort study involving both retrospective and prospective enrollment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study
Detailed description
This is a pharmacological observational study, with collection of biological material, single-centre, no-profit, involving both retrospective and prospective enrolment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study.
Primary outcome measures
- Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma.. [Time frame: 1,3 ,6 12 months post CAR-T therapy]
- Develop a predictive model of CRS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma [Time frame: 7 days post CAR-T therapy]
- Develop a predictive model of ICANS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma [Time frame: +7 days post CAR-T infusion]
Secondary outcome measures (3)
- To estimate the overall survival (OS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat) [Time frame: 12 months post CAR-T infusion]
- To estimate the progression-free survival (PFS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat) [Time frame: 12 months post CAR-T infusion]
- To describe the characteristics of all therapy-related toxicity events (other than CRS and ICANS) in patients with relapsed/refractory non-Hodgkin lymphoma who received CAR-T cell therapy up to 12 months post-infusion. [Time frame: untill 12 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Patients with relapsed/refractory non-Hodgkin lymphoma, candidates to receive CAR-T cell therapy according to clinical indication
- Acquisition of informed consent for participation in the study
- Acquisition of consent to the processing of personal data.
Exclusion criteria
none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06720701 · CLIO · RC-2024-2790609