Recruiting NCT06788652
A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lisocabtagene maraleucel.
- Who it may be relevant to
- Registry conditions: Mantle Cell Lymphoma (MCL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
Overview
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
- Biological Lisocabtagene maraleucel
According to US Prescribing Information
Primary outcome measures
- Adverse events (AEs) [Time frame: Up to 15 years]
Secondary outcome measures (4)
- 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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Center for International Blood and Marrow Transplant Research (CIBMTR) — Milwaukee
Identifiers
NCT: NCT06788652 · CA082-1093