Long-term safety of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL
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
This study is testing the long-term safety of a treatment called lisocabtagene maraleucel in people with relapsed or hard-to-treat chronic lymphocytic leukemia or small lymphocytic lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06788639 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term safety of lisocabtagene maraleucel (liso-cel) in patients diagnosed with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on individuals who have received at least one infusion of liso-cel in a post-marketing setting, contributing to pharmacovigilance efforts. The observational nature of the study allows for the collection of real-world data regarding the treatment's safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have received at least one infusion of lisocabtagene maraleucel for relapsed or refractory CLL or SLL.
Not a fit: Patients currently participating in other investigational studies or treated with non-conforming CAR T-cell products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of liso-cel, potentially improving treatment protocols for CLL and SLL patients.
How similar studies have performed: Other studies have shown success in evaluating the safety of CAR T-cell therapies, making this approach relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milwaukee, Wisconsin
- Center for International Blood and Marrow Transplant Research (CIBMTR) — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.