Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Conditions
Keywords
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
Brief summary
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
BIOLOGICALLisocabtagene maraleucel
According to the United States 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 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
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