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The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving lisocabtagene maraleucel treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisocabtagene maraleucel | Biological | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) of interest | AEs of interest include:
| Up to 15 years |
| Incidence of other adverse events (AEs) of interest | Other clinically important events that have not yet been identified as part of the liso-cel safety profile | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to 15 years | |
| Overall response rate (ORR) | Up to 15 years | |
| Complete remission rate (CRR) |
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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:
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The study population will include adults with relapsed/refractory follicular lymphoma that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIBMTR | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Up to 15 years |
| Duration of response (DOR) | Up to 15 years |
| Progression-free survival (PFS) | Up to 15 years |
| Time to next treatment (TTNT) | Up to 15 years |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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