A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Follicular Lymphoma

Interventions

Lisocabtagene maraleucelBIOLOGICAL

As per product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CIBMTR

Milwaukee, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) of interest

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)

Time frame: 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

Time frame: Up to 15 years

Secondary Outcomes

Overall survival (OS)

Time frame: Up to 15 years

Overall response rate (ORR)

Time frame: Up to 15 years

Complete remission rate (CRR)

Time frame: Up to 15 years

Duration of response (DOR)

Time frame: Up to 15 years

Progression-free survival (PFS)

Time frame: Up to 15 years

Time to next treatment (TTNT)

Time frame: Up to 15 years

Central Contacts

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

Data from ClinicalTrials.gov

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