(BRAMble) Brukinsa Real-world Analysis in Marginal zone Lymphoma
BRAMbLe (Brukinsa Real-world Analysis in Marginal zone Lymphoma) is a UK Lymphoma Research Group multicentre, non-interventional, retrospective, observational study aimed at collecting clinical outcome data for patients with relapsed/refractory MZL who were treated with zanubrutinib within the Pre-Reimbursement Access Programme (PRAP) in the United Kingdom.
National Institute for Clinical Excellence (NICE) approval was granted to zanubrutinib in July 2024 for the treatment of patients with relapsed or refractory MZL after at least one prior line of anti-CD20 based therapy based on results of the MAGNOLIA trial (National Institute for Clinical Excellence, 2024). Prior to NICE approval, zanubrutinib was delivered in England via a PRAP to approximately 160 patients, more than double the number treated within the pivotal trial, with less stringent eligibility criteria. The current study will evaluate clinical outcomes in this larger, real-world cohort, serving as a confirmatory study and more robust evidence-base for outcomes in high-risk subsets, older and frailer patients, in turn to inform clinical decision-making, future research and international reimbursement approvals.
The study will evaluate patient characteristics and outcome data for real-world patients and report longer-term treatment outcomes to support the use of Zanubrutinib in MZL and widened patient access in other countries.
Primary Objectives:
Secondary Objectives:
This is a multicentre, retrospective, real world observational study in patients with relapsed or refractory MZL treated with zanubrutinib on the Pre-Reimbursement Access Programme.
Sites that treated at least one patient on the scheme will be identified and approached for permission to share investigator contact details with the study team to facilitate site set-up.
Data will be collected at sites and uploaded in a pseudonymised format to a secure online platform (Medidata RAVE). Data will be cleaned, checked and analysed at the Southampton Clinical Trials Unit. Data will be collected from initial diagnosis until death or last follow up at the time of data-lock. In addition to demographic and disease characteristics data, basic data will be collected on prior therapy for MZL including details of systemic therapies and response rates. Details of zanubrutinib treatment will be collected including start date, dosing (including delays and dose reductions), discontinuation reason. Efficacy and safety data will be collected including initial and best response, dates of progression, last follow-up and death, details of grade 3-5 adverse events (AEs) and grade 1-5 adverse events of special interest (AESI; cardiovascular toxicity and bleeding). Limited data on subsequent therapy will be collected.
No patient intervention is planned and data collection is expected to take 12 months.
Open
Adult patients with R/R MZL treated with zanubrutinib via the PRAP between January 2022 – July 2024. Approximately 160 patients are expected to be eligible for inclusion.
The trial is funded by BeOne (formely BeiGene)
Senior Trial Manager:
Josh Caddy
Trial Coordinator:
Ben Lindfield
Trial Assistant:
Lauren Ward
Data Manager:
Zoe Konn
Clinical Data Coordinator:
Katrin Eichorst
Statistician:
Louise Stanton
Email: bramble@soton.ac.uk
Phone: 023 8120 5154
BRAMble - Protocol, 12-Mar-2025
BRAMble - Template PI Protocol Acknowledgement Form v1.0 18-Sep-2025
BRAMble - Master Patient List v1.0, 18-Sep-2025
BRAMble - Investigator Site File Index v1.0, 20-Oct-2025
BRAMble - Site Delegation Log v1.0 18-Sep-2025
BRAMble - SIV Slides v2.0 29-Sep-2025
No publications yet.
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Coming soon