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

Recruiting

• Conditions: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
• Interventions: Biological: Lisocabtagene maraleucel

• Registration Number: NCT06788639
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2044-06-30
• Study Completion: 2044-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants treated with lisocabtagene maraleucel	Lisocabtagene maraleucel	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to 15 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center for International Blood and Marrow Transplant Research (CIBMTR); 🇺🇸 Milwaukee, Wisconsin, United States