Long-term safety and effectiveness of lisocabtagene maraleucel for Mantle Cell Lymphoma
Official title: Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed/Refractory Mantle Cell Lymphoma in the Post-Marketing Setting
Run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT06788652 · Data updated 2026-11-12
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 |
|---|---|
| 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 | September 30, 2044 |
| Study ends | September 30, 2044 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT06788652 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with relapsed or refractory Mantle Cell Lymphoma who have received at least one infusion of lisocabtagene maraleucel.
✕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 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.
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 gone: Other studies have shown promising results with CAR T-cell therapies in hematological malignancies, suggesting potential success for this approach.
Who can join: the full rules
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 it's running
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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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma
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This trial will test whether combining pirtobrutinib with rituximab is effective and safe for adults newly diagnosed with indolent mantle cell lymphoma.
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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.