The iwCLL defines "active disease" by the presence of one or more of the following criteria: |
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.* |
Massive (ie, ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly. |
Massive nodes (ie, ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy. |
Progressive lymphocytosis with an increase of >50% over a 2-month period or LDT of <6 months. LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. Patients with initial blood lymphocyte counts of <30,000/microL, may require a longer observation period to determine the LDT. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infection) should be excluded. |
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids. |
Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine). |
Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs: a. Unintentional weight loss of ≥10% within the previous 6 months b. Significant fatigue (ie, ECOG PS ≥2; inability to work or perform usual activities) c. Fevers >100.5°F or 38.0°C for ≥2 weeks without other evidence of infection d. Night sweats for ≥1 month without evidence of infection |
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