A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

Recruiting

• Conditions: Mantle Cell Lymphoma (MCL)
• Interventions: Biological: Lisocabtagene maraleucel

• Registration Number: NCT06788652
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Brief Summary

The purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of Mantle Cell Lymphoma (MCL).

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: 2044-09-30
• Study Completion: 2044-09-30

Recruitment & Eligibility

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

Inclusion Criteria

• Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA

Exclusion Criteria

• Participants known to be participating in investigational studies at the time of liso-cel infusion.
• Participants 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