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

NCT06794268 | Recruiting FDA Drug

• 1 other identifier: CA082-1175
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Follicular Lymphoma

Keywords

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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)

  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

Secondary Outcomes (6)

• 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

Study Arms (1)

Participants receiving lisocabtagene maraleucel treatment

Biological: Lisocabtagene maraleucel

Interventions

Lisocabtagene maraleucel BIOLOGICAL

As per product label

Participants receiving lisocabtagene maraleucel treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (1)

CIBMTR

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): August 31, 2044
• Study Completion (Estimated): August 31, 2044
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)