Marginal Zone Lymphoma
Conditions
Keywords
lisocabtagene maraleucel, liso-cel, Breyanzi, relapsed/refractory marginal zone lymphoma, R/R MZL, chimeric antigen receptor T cell therapy, CAR T cell therapy, CIBMTR registry
Brief 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.
Interventions
BIOLOGICALlisocabtagene maraleucel
As per United States prescribing information
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed