A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic 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: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL). 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 Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Post-Marketing Setting
Overview
The purpose of this study is to characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities
Interventions
- Biological Lisocabtagene maraleucel
According to the United States 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 post-marketing setting with ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA
Exclusion criteria
- Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion
- Patients 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: NCT06788639 · CA082-1092