Long-term safety of lisocabtagene maraleucel in patients with relapsed follicular lymphoma
Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Follicular Lymphoma in the Postmarketing Setting
This study is testing the long-term safety of a treatment called lisocabtagene maraleucel in people with relapsed follicular lymphoma who have already received it.
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 | chimeric antigen receptor |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06794268 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term safety of lisocabtagene maraleucel (liso-cel) in patients who have been treated for relapsed or refractory follicular lymphoma. It focuses on individuals who have received at least one infusion of liso-cel in a post-marketing setting, contributing to pharmacovigilance efforts. The study will collect data on patient outcomes and safety profiles to better understand the treatment's effects over time.
Who should consider this trial
Good fit: Ideal candidates are patients with relapsed or refractory follicular lymphoma who have received liso-cel treatment in accordance with FDA-approved guidelines.
Not a fit: Patients treated with liso-cel for follicular lymphoma Grade 3b or those participating in other investigational studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of liso-cel for patients with follicular lymphoma.
How similar studies have performed: While this study focuses on post-marketing safety, similar studies evaluating CAR T-cell therapies have shown promising results in terms of safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-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 liso-cel, infusion * Participants treated with liso-cel for the treatment of R/R FL Grade 3b * Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product
Where this trial is running
Milwaukee, Wisconsin
- 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.