A new study that aims to identify biomarkers that can predict the outcomes of diffuse large B-cell lymphoma (DLBCL) therapies is now open.
The multicenter, observational study funded by the Fondazione Policlinico Universitario Agostino Gemelli IRCCS aims to recruit 300 participants with relapsed/refractory DLBCL, 18 years of age and above, in Napoli, Italy.
Read more about DLBCL therapies
The specific aims of the study are to explore the association between the expression of target antigens on the surface of neoplastic DLBCL cells and the response to targeted therapies, identify specific microRNA (miRNA) signatures that could predict the response to upfront and salvage immune chemotherapies, and refine the diagnosis and molecular profiling of DLBCL to provide information that could have prognostic relevance.
The study will last 2 years. The first 4 months will consist of the retrospective part of the study. Then, the accrual of patients for the prospective part will start. The prospective samples will be analyzed until the end of the study.
An in vitro model will be developed during the first year, and in vitro experiments will be performed until the end of the study. The statistical analysis and interpretation of the data will be done in the final months.
The primary outcome measure will be the complete remission rates according to miRNA signatures, target antigen expressions, and mutational status.
The estimated study start date is April 1, 2023, and the estimated primary completion date is March 31, 2025.
DLBCL is a cancer of the lymphatic system in which B cells become abnormal and infiltrate tissues and organs in a widespread, diffuse pattern. DLBCL can be fatal because it grows rapidly and involves multiple organ systems.
There are different subtypes of DLBCL depending on the stage of B-cell differentiation at the onset of genetic alteration and the type of genetic mutation. The molecular classification of subtypes increases the likelihood of successful treatment as it allows the use of customized therapy with novel agents targeting each subtype.
Reference
Predictive biomarkers including miRNA-based tumor signatures in diffuse large B cell lymphoma (R/R DLBCL) (MIMOSA) (MIMOSA). ClinicalTrials.gov. February 28, 2023. Accessed March 8, 2023.
