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

Recruiting

• Conditions: Follicular Lymphoma
• Interventions: Biological: Lisocabtagene maraleucel

• Registration Number: NCT06794268
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Status Verified: 2025-02
• Study Start: 2025-02-04
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2044-08-31
• Study Completion: 2044-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving lisocabtagene maraleucel treatment	Lisocabtagene maraleucel	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 15 years
Overall response rate (ORR)	Up to 15 years
Complete remission rate (CRR)	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

Trial Locations

Locations (1)

CIBMTR; 🇺🇸 Milwaukee, Wisconsin, United States