Abstract
Background: Recent studies have suggested promising roles for immunotherapy through CD40 ligand /IL-2 signaling pathway in CLL patients. Differential expression of the IL-2 receptor (IL-2 R) has been reported in CLL and other B-cell malignancies. Because CLL is divided into two distinct prognostic groups (based on the level of somatic hypermutation or alternatively on the presence or absence of ZAP-70), it is important to determine the correlation of IL-2 R expression with mutational status and/or ZAP-70 positivity in CLL for better patient group stratification in clinical trials. 
 Methods: In this study, 132 pts (82 M/50F; M: F 1.6) with an age range of 33-91 yrs (median 66 yrs) were included. Of these, 67/132 (51%) were found to be CD25+, 44/132 (33%) CD25- and 16% were CD25 dim (not further analyzed). In terms of ZAP positivity, 19/132 (14%) pts were ZAP-70+ and 113 (86%) were ZAP-70-. 
 Results: Mutational data (n=93) revealed 60/93 (65%) patients with SHM and 33/ 93 (35%) without. Correlation between ZAP-70+ and absence of SHM was highly significant (p< 0.0001), however, no statistically significant correlation was noted between CD25 expression and SHM (p= 0.331) or ZAP positivity (p= 0.785). 
 Conclusions: This data suggests that IL-2 R expression, although noted among a significant proportion of patients with B-CLL, is independent of somatic hypermutation or ZAP-70 expression. This observation will be important in evaluation of clinical efficacy of immunotherapy among CLL patients, and points to the existence of another mechanism for the presence of IL-2 R in these patients. 
 
 Abbreviations: B-CLL (B-cell Chronic Lymphocytic Leukemia), SHM (Somatic Hypermutation)
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