DISEASE BACKGROUND AND RATIONALE Sample Clauses

DISEASE BACKGROUND AND RATIONALE. Mantle cell lymphoma is an aggressive, generally incurable, B-cell malignancy, representing approximately 6% of non-Hodgkin lymphomas (NHLs). Approximately 4000 new cases are diagnosed yearly in the United States (Leukemia & Lymphoma Society 2014). The lymphoma cells are thought to originate from naïve pregerminal center B cells within the mantle zone, and they typically express CD5, CD19, CD20, surface IgM, and surface IgD (Xxxxxxxx 2014), but not CD11c (Xxxxx et al, 2010). More than 95% of MCLs carry translocation t(11;14)(q13;q32), which places the cyclin D1 gene in proximity of the immunoglobulin heavy chain locus, resulting in overexpression of cyclin D1, which can be detected by cytogenetics or fluorescence in situ hybridization (National Comprehensive Cancer Network 2017). Most patients are male, and the median age of diagnosis is 68 years (Xxxxxx and Xxxx 2017). Patients typically present with advanced lymphadenopathy, and also show extranodal involvement of the spleen, bone marrow, and gastrointestinal (GI) tract (Xxxxxxxx et al, 2014; Xxxxxx and Xxxxxxxxxx 2015; National Comprehensive Cancer Network 2017; Xxxx 2017). Prognosis varies based on clinical and laboratory parameters and can be estimated using the mantle cell international prognostic index. This index uses the 4 independent prognostic factors of age, performance status, lactate dehydrogenase (LDH), and leukocyte count to classify patients as low risk (60% to 83% 5-year overall survival [OS]), intermediate (35% to 63% 5-year OS), or high risk (20% to 34% 5-year OS) (Hoster et al, 2008; Hoster et al, 2014).
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