A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

Juno Therapeutics

Status: Enrolling

Conditions: Small Lymphocytic Lymphoma (SLL); Chronic Lymphocytic Leukemia (CLL)

Treatments: Biological: Lisocabtagene maraleucel

Study type: Observational

Funder types: Industry

Identifiers

NCT06788639

CA082-1092

Details and patient eligibility

About

The purpose of this study is to characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) 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 ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the 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 lisocabtagene maraleucel infusion
• Patients treated with non-conforming CAR T-cell product

Trial design

300 participants in 1 patient group

Participants treated with lisocabtagene maraleucel

Treatment:

Biological: Lisocabtagene maraleucel