A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
1 other identifier
observational
300
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2025
CompletedStudy Start
First participant enrolled
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2044
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2044
February 24, 2025
February 1, 2025
19.7 years
January 17, 2025
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
Up to 15 years
Secondary Outcomes (4)
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
Study Arms (1)
Participants treated with lisocabtagene maraleucel
Interventions
According to US Prescribing Information
Eligibility Criteria
The study population will include adults diagnosed with Relapsed/Refractory Mantle Cell Lymphoma (MCL) who are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry and have been treated with lisocabtagene maraleucel.
You may qualify if:
- 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
You may not qualify if:
- Participants known to be participating in investigational studies at the time of liso-cel infusion.
- Participants treated with non-conforming CAR T-cell product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for International Blood and Marrow Transplant Research (CIBMTR)
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2025
First Posted
January 23, 2025
Study Start
February 4, 2025
Primary Completion (Estimated)
September 30, 2044
Study Completion (Estimated)
September 30, 2044
Last Updated
February 24, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share