Diagnosis Of

Two CLL working groups, the International Workshop on CLL (IWCLL) and the National Cancer Institute Working Group

(NCIWG) have summarized the diagnostic criteria for CLL.20,21 The IWCLL proposed the following criteria:

1. A sustained peripheral blood lymphocyte count above 10 X 109 /L, with most of the cells being mature-appearing lymphocytes

2. A bone marrow aspirate showing more than 30 percent lymphocytes

3. Peripheral blood lymphocytes identified as monoclonal B cells

The diagnosis of CLL is established if either criteria 1 and 2 or 3 apply. If the peripheral blood lymphocyte count is below 10 X 109/L, then both criteria 2 and 3 must apply.

The NCIWG criteria are similar to those proposed by the IWCLL:

1. A peripheral blood lymphocyte count above 5 X 109/L, with less than 55 percent of the cells being atypical or immature lymphoid cells. The cells should be monoclonal B lymphocytes having B-cell surface antigens (CD19, CD20, CD23) and a low density of surface immunoglobulin (IgM or IgD), with either kappa or lambda light chains, and should be CD5-positive.

2. Fewer than 30 percent of marrow nucleated cells should be lymphocytes.

The IWCLL addressed the minimum diagnostic requirements for CLL that can be applied universally, whereas the NCIWG concentrated on criteria of eligibility to enroll patients in prospective studies. For these purposes, the NCIWG required immunophe-notyping. Thus, these criteria accept a lower threshold lymphocyte count of more than 5 X 109/L to diagnose B-cell CLL, whereas for clinical applications of minimum diagnostic criteria, particularly in countries where immunophenotyping is not available, the IWCLL recommends a threshold lymphocyte count of >10 X 109/L. With the use of immunophenotying, a bone marrow examination is not required to make the diagnosis of CLL but, as discussed below, it provides prognostic information.

Several B-cell malignancies in which there are increased numbers of small lymphoid cells in the peripheral blood have overlapping clinical manifestations and should be differentiated from CLL. The three disorders most likely to be confused with CLL are prolymphocytic leukemia (PLL), the leukemic phase of non-Hodgkin's lymphoma (usually mantle-cell lymphoma, fol-licular lymphoma, or splenic lymphoma with circulating villous lymphocytes), and hairy cell leukemia. Immunophenotyping is helpful in differentiating these disorders (Table 7-1).

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