International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for "active disease"

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

The table provides the iwCLL criteria for "active disease", which identify patients for whom therapy is indicated. Lymphocytosis itself, even if extreme, is not an indication for treatment if patients have no symptoms and adequate bone marrow function. Likewise, hypogammaglobulinemia or monoclonal or oligoclonal paraproteinemia does not by itself constitute a basis for initiating therapy.

iwCLL: International Workshop on Chronic Lymphocytic Leukemia; LDT: lymphocyte doubling time; ECOG: Eastern Cooperative Oncology Group; PS: performance status.
* The decision to initiate treatment based on evidence of progressive marrow failure must rely on the clinical judgment of the treating physician. Hemoglobin <10 g/dL or platelet count <100,000/microL are generally regarded as indications for treatment. However, platelet counts <100,000/microL may remain stable over a long period of time in some patients; this situation does not automatically require therapeutic intervention.

Reproduced with permission of the American Society of Hematology, from: Hallek M, Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood 2018; 131:2745; permission conveyed through Copyright Clearance Center, Inc. Copyright © 2018.

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International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for "active disease"