CD38 as a prognostic indicator in chronic lymphocytic leukemia

Abstract

The subject invention discloses a method for determining the prognosis and probable clinical course of a subject diagnosed with B-CLL. Specifically, the invention involves comparing CD38 expression in a biological sample from the subject containing B-CLL cells to a baseline level of CD38 expression, wherein an elevated level of CD38 expression in relation to the baseline level of CD38 expression may indicate poor prognosis or aggressive course of disease in the subject. Also disclosed is a method for determining whether the Ig V genes of the B-CLL cells of a B-CLL patient are mutated, comprising comparing CD38 expression in a biological sample from the subject containing B-CLL cells to a baseline level of CD38 expression, wherein a lower level of CD38 expression in relation to the baseline level indicates IG V gene mutation.

1 - 14 . (canceled) 
     
     
         15 . A method for determining the prognosis of B cell chronic lymphocytic leukemia (“B-CLL”) in a subject with B-CLL, the method comprising
 determining whether a blood sample from the subject comprises B-CLL cells having a mutated Ig V gene, 
 wherein the absence of a mutated Ig V gene indicates a poor prognosis versus an indolent disease course. 
 
     
     
         16 . The method of  claim 15 , wherein whether the Ig V gene is mutated is assessed by comparing the DNA sequence of the Ig V gene of the B-CLL cells of the sample with a control germline DNA sequence of the Ig V gene, wherein a ≧2% difference between the DNA sequence of the Ig V gene of the B-CLL cells of the sample and the control germline DNA sequence of the Ig V gene is indicative of a mutated Ig V gene. 
     
     
         17 . The method of  claim 15 , wherein whether the Ig V gene is mutated is assessed by comparing the DNA sequence of the Ig V H  gene or Ig V L  gene of the B-CLL cells of the sample with a control germline DNA sequence of the Ig V H  gene or Ig V L  gene, wherein a ≧2% difference between the DNA sequence of the Ig V H  gene or Ig V L  gene of the B-CLL cells of the sample and the control germline DNA sequence of the Ig V H  gene or Ig V L  gene, respectively, is indicative of a mutated Ig V gene.