RecruitingObservational

Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Post-Marketing Setting

NCT ID: NCT06788639Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLast updated: 2025-02-24

Summary

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

Arms & interventions

BiologicalLisocabtagene maraleucel
According to the United States Prescribing Information

Outcome measures

Primary

Adverse events (AEs)
Time frame: Up to 15 years

Secondary

Complete remission rate (CRR
Time frame: Up to 15 years
Overall response rate (ORR)
Time frame: Up to 15 years
Progression-free survival (PFS)
Time frame: Up to 15 years
Overall survival (OS)
Time frame: Up to 15 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Center for International Blood and Marrow Transplant Research (CIBMTR)

Milwaukee, Wisconsin, 53226

Recruiting