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

Juno Therapeutics

Status: Enrolling

Conditions: Follicular Lymphoma

Treatments: Biological: Lisocabtagene maraleucel

Study type: Observational

Funder types: Industry

Identifiers

NCT06794268

CA082-1175

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA

Exclusion criteria

• 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

Trial design

300 participants in 1 patient group

Participants receiving lisocabtagene maraleucel treatment

Treatment:

Biological: Lisocabtagene maraleucel