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RecruitingObservational
Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
NCT ID: NCT06788652Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLast updated: 2025-02-24
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).
Arms & interventions
- BiologicalLisocabtagene maraleucel
According to US 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 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 locations (1)
Center for International Blood and Marrow Transplant Research (CIBMTR)
Milwaukee, Wisconsin, 53226