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RecruitingNCT06794268Updated Feb 24, 2025

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

An observational study in Follicular Lymphoma, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Follicular Lymphoma

Keywords

  • Follicular Lymphoma
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 300 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company is the lead sponsor of 17 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants receiving lisocabtagene maraleucel treatment

    Biological: Lisocabtagene maraleucel

Interventions

  • BiologicalLisocabtagene maraleucel

    As per product label

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What researchers measure

Primary outcomes

  1. 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

  2. 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 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

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Study locations

1 of 1 sites recruiting
  • CIBMTR
    Milwaukee, Wisconsin 53226, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06794268
Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Responsible party
Sponsor
First posted
Jan 27, 2025
Start date
Feb 4, 2025
Primary completion
Aug 31, 2044 (estimated)
Completion
Aug 31, 2044 (estimated)
Last update
Feb 24, 2025

Study contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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