Actively Recruiting
Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2025-02-24
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying lisocabtagene maraleucel (liso-cel) to understand its long-term safety and effectiveness in treating patients with Mantle Cell Lymphoma (MCL) who have relapsed or refractory disease. This observational study focuses on patients treated with liso-cel following its approval and commercial release in the United States. The study aims to gather data for up to 15 years after treatment to provide a comprehensive view of patient outcomes. Participants in this study have already received at least one infusion of lisocabtagene maraleucel according to the FDA-approved guidelines and dosage. The study does not involve assigning treatments but rather observes patients who have been treated with liso-cel in routine clinical practice. There are no additional interventions or comparators. During the study, researchers will collect information about adverse events, complete remission rates, overall response rates, progression-free survival, and overall survival for up to 15 years. Participants' health will be monitored through routine data collection, without extra procedures or treatments mandated by the study. The long follow-up period allows for detailed assessment of the treatment's impact over time.
CONDITIONS
Brief Title
A Study of Patients With Relapsed/Refractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) for Mantle Cell Lymphoma (MCL) as per FDA-approved indication and dose range
You will not qualify if you...
- Participants currently participating in investigational studies at the time of liso-cel infusion
- Participants treated with non-conforming CAR T-cell products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 15 years
Participants who have been treated with lisocabtagene maraleucel for Mantle Cell Lymphoma are observed for safety and effectiveness outcomes.
Trial Site Locations
Total: 1 location
1
Center for International Blood and Marrow Transplant Research (CIBMTR)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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