Mantle Cell Lymphoma (MCL)
Conditions
Keywords
Mantle Cell Lymphoma (MCL)
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).
Interventions
BIOLOGICALLisocabtagene maraleucel
According to US Prescribing Information
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Up to 15 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed