Liso-Cel in Relapsed/Refractory Marginal Zone Lymphoma

NCT07777120 — Active not recruiting, 300 participants, Bristol-Myers Squibb

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

RegistryNCT07777120
StatusActive not recruiting
Study typeObservational
Enrollment300 (Estimated)
SponsorBristol-Myers Squibb (Industry)
ConditionsMarginal Zone Lymphoma
Interventionslisocabtagene maraleucel (Biological)
Datesstart 2026-03-24, primary completion 2048-03-31 (estimated), completion 2048-03-31 (estimated), first posted 2026-08-20, last updated 2026-08-20
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Marginal Zone Lymphoma All trials of lisocabtagene maraleucel

-Summary

This non-interventional study will use information already reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) registry during routine clinical care. The study will assess the long-term safety and effectiveness of lisocabtagene maraleucel in participants with relapsed/refractory marginal zone lymphoma.

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+Arms and interventions

ArmTypeInterventionsDescription
Lisocabtagene maraleucelBiological: lisocabtagene maraleucelAdult participants with relapsed or refractory marginal zone lymphoma (R/R MZL) treated with lisocabtagene maraleucel
  • lisocabtagene maraleucel (Biological): As per United States prescribing information

+Outcome measures

Primary outcomes

  • Incidence and severity of selected adverse events after lisocabtagene maraleucel infusion [Up to 15 years]: Selected adverse events include: * secondary malignancies * cytokine release syndrome (CRS) Grade ≥ 3 * neurotoxicity Grade ≥ 3 * prolonged cytopenias * pregnancy outcome * treatment-emergent adverse events including: hypogammaglobulinemia, tumor lysis syndrome Grade ≥ 3, serious infections requiring treatment, organ toxicities Grade ≥ 3, hemophagocytic lymphohistiocytosis/macrophage activation syndrome-like toxicities, aggravated graft-versus-host disease, and other toxicities occurring after lisocabtagene maraleucel infusion.

Secondary outcomes

  • Overall survival from first lisocabtagene maraleucel infusion [Up to 15 years]: Overall survival is the time from the date of first lisocabtagene maraleucel infusion to the date of death due to any cause.
  • Overall response rate after lisocabtagene maraleucel infusion [Up to 15 years]: Overall response rate is the proportion of participants with a best overall response of complete response or partial response, recorded from the time of lisocabtagene maraleucel infusion until disease relapse or progression, end of study, or the start of new anti-cancer therapy including hematopoietic stem cell transplantation.
  • Complete response rate after lisocabtagene maraleucel infusion [Up to 15 years]: Complete response rate is the proportion of participants with a best overall response of complete response from the time of lisocabtagene maraleucel infusion until disease relapse or progression, end of study, or the start of another anti-cancer therapy including hematopoietic stem cell transplantation.
  • Progression-free survival from first lisocabtagene maraleucel infusion [Up to 15 years]: Progression-free survival is the time from the date of first lisocabtagene maraleucel infusion to the date of event, defined as the first documented relapse or progression or death due to any cause, whichever happens first.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Participants who meet the following eligibility criteria will be selected from the registry:

* Participants of 18 years of age or older at the time of infusion
* Participants with a diagnosis of relapsed or refractory marginal zone lymphoma (R/R MZL)
* Participants have received at least two prior lines of systemic therapy
* Participants have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel:

  * used for the treatment of R/R MZL,
  * within the FDA-approved indication and dosage per the United States prescribing information and
  * product specifications approved for commercial release in the USA.
* Participants have consented to share their data with the registry and the Sponsor.

Exclusion Criteria:

Participants who meet the following exclusion criterion will not be eligible for selection from the registry:

• Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion.

+Locations (1)

FacilityCityCountryStatus
Center for International Blood and Marrow Transplant Research (CIBMTR)Milwaukee, WisconsinUnited States

+Investigators

  • Bristol Myers Squibb, Study director, Bristol-Myers Squibb