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NCT Number: NCT06794268

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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIBMTR

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lisocabtagene Maraleucel

Biological

As per product label

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 15 years

  2. Overall response rate (ORR)

    Time frame: Up to 15 years

  3. Complete remission rate (CRR)

    Time frame: Up to 15 years

  4. Duration of response (DOR)

    Time frame: Up to 15 years

  5. Progression-free survival (PFS)

    Time frame: Up to 15 years

  6. Time to next treatment (TTNT)

    Time frame: Up to 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2044
Study completion
2044
First posted
Jan 27, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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