Table 2.

Criteria for treatment initiation

• Progressive BM failure with the development or aggravation of anemia and/or thrombocytopenia.

• Massive or progressive or symptomatic splenomegaly.

• Significantly enlarged or symptomatic or progressive lymphadenopathies.

• Progressive lymphocytosis, with an increase of more than 50% over a period of 2 months or an LDT of less than 6 months. In patients with an initial lymphocyte count <30 × 109/L, LDT alone should not be used as a single parameter to decide treatment initiation and should be interpreted in the overall clinical context.

• Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapies.

• The presence of constitutive symptoms as defined by 1 or more of the following signs or symptoms related to the disease:

Unintentional weight loss of 10% or more in the previous 6 months, significant fatigue (ECOG PS 2 or worse; inability to perform usual activities), fever over 38.0 °C for 2 weeks or more without signs of infection, and night sweats lasting more than a month with no sign of infection.

At least one of the criteria must be fulfilled.