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

February 21, 2025 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Follicular Lymphoma in the Postmarketing Setting

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • CIBMTR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants receiving lisocabtagene maraleucel treatment
Biological: Lisocabtagene maraleucel
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) of interest
Time Frame: 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)
Up to 15 years
Incidence of other adverse events (AEs) of interest
Time Frame: Up to 15 years
Other clinically important events that have not yet been identified as part of the liso-cel safety profile
Up to 15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 15 years
Up to 15 years
Complete remission rate (CRR)
Time Frame: Up to 15 years
Up to 15 years
Overall response rate (ORR)
Time Frame: Up to 15 years
Up to 15 years
Progression-free survival (PFS)
Time Frame: Up to 15 years
Up to 15 years
Duration of response (DOR)
Time Frame: Up to 15 years
Up to 15 years
Time to next treatment (TTNT)
Time Frame: Up to 15 years
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2025

Primary Completion (Estimated)

August 31, 2044

Study Completion (Estimated)

August 31, 2044

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA082-1175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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