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
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.
Study Type
OBSERVATIONAL
Enrollment
125
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, Italy
Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma..
The outcome of objective 1 is the occurrence of one of the following conditions: complete response (CR) or partial response (PR) or stable response (SD) or progression of disease (PD). The outcome will be assessed by performing a PET/CT radiological examination. The response to treatment \[(Overall Response Rate (ORR), or CR + PR\] is defined as negativization of the uptake or Deauville score ≤3. The non-response to treatment/refractoriness \[SD + PD\] is defined as persistence/increase of the uptake, or Deuville Score \>3.
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
The outcome of this objective is the occurrence of CRS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 CRS toxicity on treatment is defined as the incidence of CRS events of grade ≥1 and/or the incidence of ICANS of grade ≥1
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
The outcome of this objective is the occurrence of ICANS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 ICANS toxicity on treatment is defined as the incidence of ICANS events of grade ≥1.
Time frame: +7 days post CAR-T infusion
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)
Death from any cause
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)
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disease status by PET/CT examination and defined as negative uptake or Deauville score ≤3.
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.
Type, grade (according to CTCAE 5.0), onset date, end date, outcome
Time frame: untill 12 months