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RecruitingObservational

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

NCT ID: NCT06794268Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLast updated: 2025-02-24

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

Arms & interventions

  • BiologicalLisocabtagene maraleucel

    As per product label

Outcome measures

Primary

  • 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

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

CIBMTR

Milwaukee, Wisconsin, 53226

Recruiting