Long-term safety and effectiveness of lisocabtagene maraleucel for Mantle Cell Lymphoma
Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
This study looks at how safe and effective the treatment lisocabtagene maraleucel is for people with relapsed or refractory Mantle Cell Lymphoma over a long period of time.
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 | NCT06788652 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) in patients with relapsed or refractory Mantle Cell Lymphoma (MCL) who have received treatment in a post-marketing setting. Participants must have undergone at least one infusion of liso-cel according to FDA-approved guidelines. The study is observational, meaning it will collect data on patient outcomes without altering their treatment regimen. The goal is to gather real-world evidence on the use of this therapy in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients with relapsed or refractory Mantle Cell Lymphoma who have received at least one infusion of lisocabtagene maraleucel.
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 outcomes and safety profile of liso-cel for patients with MCL.
How similar studies have performed: Other studies have shown promising results with CAR T-cell therapies in hematological malignancies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA Exclusion Criteria: * Participants known to be participating in investigational studies at the time of liso-cel infusion. * Participants 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.