lisocabtagene maraleucel: As per United States prescribing information
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Center for International Blood and Marrow Transplant Research (CIBMTR)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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