Long-term safety of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL
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
Run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT06788639 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | February 4, 2025 |
| Main results expected | June 30, 2044 |
| Study ends | June 30, 2044 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT06788639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in evaluating the safety of CAR T-cell therapies, making this approach relevant and potentially beneficial.
Who can join: the full rules
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 it's running
-
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
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.