Follicular Lymphoma
Conditions
Keywords
Follicular Lymphoma
Brief summary
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
Interventions
BIOLOGICALLisocabtagene maraleucel
As per product label
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) of interest | Up to 15 years | AEs of interest include: * Secondary malignancies * Cytokine release syndrome (CRS) Grade ≥ 3 * Neurotoxicity Grade ≥ 3 * Prolonged cytopenias * Pregnancy outcome * Tumor lysis syndrome (TLS) Grade ≥ 3 * Serious infections (ie, those requiring treatment) * Organ toxicities Grade ≥ 3 * Hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS)-like toxicities * Aggravated graft-versus-host disease (GvHD) |
| Incidence of other adverse events (AEs) of interest | Up to 15 years | Other clinically important events that have not yet been identified as part of the liso-cel safety profile |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate (CRR) | Up to 15 years |
| Duration of response (DOR) | Up to 15 years |
| Overall survival (OS) | Up to 15 years |
| Time to next treatment (TTNT) | Up to 15 years |
| Progression-free survival (PFS) | Up to 15 years |
| Overall response rate (ORR) | Up to 15 years |
Countries
United States
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed