The National Cancer Institute-sponsored Working Group (NCI-WG) developed criteria to identify patients with chronic lymphocytic leukemia showing disease activity. These are similar to the criteria of Rai et al for making a therapeutic intervention.


NCI-WG criteria for active CLL - presence of at least one of the following:

(1) one or more of the following disease-related symptoms

(1a) weight loss >= 10% within the previous 6 months, without trying to lose weight

(1b) extreme fatigue

(1c) fevers > 100.5°F for >= 2 weeks without evidence of infection

(1d) night sweats without evidence of infection

(2) evidence of progressive marrow failure

(3) autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy

(4) massive or progressive splenomegaly

(5) massive or progressive lymphadenopathy

(6) progressive lymphocytosis with an increase > 50% over a 2 month period, or an anticipated doubling time of < 6 months.



• Progressive marrow failure is indicated by the development of, or worsening of, anemia and thrombocytopenia.

• Extreme fatigue is ECOG performance status 2 or worse; the patient cannot work or is unable to perform usual activities.

• Massive splenomegaly is > 6 cm below the left costal margin.

• Massive lymphadenopathy is > 10 cm in maximum diameter.


Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient evidence of active disease.


The criteria of Rai et al differ from those of the NCI-WG in that the following were included as criteria for starting treatment:

(6) A doubling time of < 12 months, rather than < 6 months

(6) A blood lymphocyte count > 150,000 per µL

(7) An increased susceptibility to bacterial infection


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