The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities
None
Participants known to be participating in investigational studies at the time of liso-cel, infusion
Participants treated with liso-cel for the treatment of R/R FL Grade 3b
Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product
The study population will include adults with relapsed/refractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
Cohort
Prospective
Lisocabtagene maraleucel
Biological/VaccineAs per product label
Incidence of adverse events (AEs) of interest
AEs of interest include: * Secondary malignancies * Cytokine release syndrome (CRS) Grade ≥ 3 * Neurotoxicity Grade ≥ 3 * Prolonged cytopenias * Pregnancy outcome * Tumor lysis syndrome (TLS) Grade ≥ 3 * Serious infections (ie, those requiring treatment) * Organ toxicities Grade ≥ 3 * Hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS)-like toxicities * Aggravated graft-versus-host disease (GvHD)
Incidence of other adverse events (AEs) of interest
Other clinically important events that have not yet been identified as part of the liso-cel safety profile
Overall survival (OS)
Overall response rate (ORR)
Complete remission rate (CRR)
Duration of response (DOR)
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