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Active, not recruiting

NCT Number: NCT07777120

Liso-Cel in Relapsed/Refractory Marginal Zone Lymphoma

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for International Blood and Marrow Transplant Research (CIBMTR)

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lisocabtagene Maraleucel

Biological

As per United States prescribing information

Primary outcomes

  1. Incidence and severity of selected adverse events after lisocabtagene maraleucel infusion

    Time frame: 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

  1. Overall survival from first lisocabtagene maraleucel infusion

    Time frame: 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.

  2. Overall response rate after lisocabtagene maraleucel infusion

    Time frame: 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.

  3. Complete response rate after lisocabtagene maraleucel infusion

    Time frame: 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.

  4. Progression-free survival from first lisocabtagene maraleucel infusion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2048
Study completion
2048
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

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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