A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting

Condition(s) studied

Investigational drug(s) / intervention(s)

Lisocabtagene maraleucel: As per product label

Study summary

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

Eligibility

Primary outcome measure(s)

• Incidence of adverse events (AEs) of interest — Up to 15 years
  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 — Up to 15 years
  Other clinically important events that have not yet been identified as part of the liso-cel safety profile

Trial sites (1)

More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in the USA

Other trials for the same condition