Actively Recruiting
Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel for Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic 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 the long-term safety of lisocabtagene maraleucel (liso-cel) in patients who have relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This study is part of post-marketing pharmacovigilance activities to monitor patients treated with liso-cel outside of clinical trials. The study observes patients who have received at least one infusion of lisocabtagene maraleucel according to the approved U.S. prescribing information and commercial product specifications. It is a non-interventional observational study monitoring these patients in their regular care setting without assigning specific treatments. Participants will be followed for up to 15 years to record adverse events and evaluate outcomes such as complete remission rate, overall response rate, progression-free survival, and overall survival. Data collection will focus on safety and effectiveness measures to better understand the long-term impact of liso-cel treatment.
CONDITIONS
Brief Title
A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have received at least one infusion of lisocabtagene maraleucel for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following the approved U.S. prescribing information and commercial product specifications
You will not qualify if you...
- Participants currently involved in other investigational studies at the time of lisocabtagene maraleucel infusion
- Patients treated with CAR T-cell products that do not conform to approved specifications
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 received lisocabtagene maraleucel are observed over time to assess safety and treatment outcomes in a non-interventional setting.
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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