Liso-Cel in Relapsed/Refractory Marginal Zone Lymphoma

N/AActive Not RecruitingNCT07777120

Bristol-Myers Squibb300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Marginal Zone Lymphoma

Interventions

lisocabtagene maraleucelBIOLOGICAL

As per United States prescribing information

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Center for International Blood and Marrow Transplant Research (CIBMTR)

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Incidence and severity of selected adverse events after lisocabtagene maraleucel infusion

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.

Time frame: Up to 15 years

Secondary Outcomes

Overall survival from first lisocabtagene maraleucel infusion

Overall survival is the time from the date of first lisocabtagene maraleucel infusion to the date of death due to any cause.

Time frame: Up to 15 years

Overall response rate after lisocabtagene maraleucel infusion

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.

Time frame: Up to 15 years

Complete response rate after lisocabtagene maraleucel infusion

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.

Time frame: Up to 15 years

Progression-free survival from first lisocabtagene maraleucel infusion

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.

Data from ClinicalTrials.gov

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