Complete remission (CR) |
Requires all of the following criteria: - Absolute lymphocyte count <4000/microL (4 × 109/L).
- No lymph nodes >1.5 cm in diameter.
- No hepatomegaly or splenomegaly.
- No constitutional symptoms attributable to CLL.*
- Bone marrow recovery as demonstrated by ANC >1500/microL (1.5 × 109/L), platelet count >100,000/microL (100 × 109/L), and hemoglobin concentration >11 g/dL (110 g/L) in the absence of transfusion or growth factor support.
- Bone marrow at least normocellular for age, without evidence for typical CLL lymphocytes by morphologic criteria and immunohistochemistry and without nodular lymphoid aggregates.¶
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CR with incomplete bone marrow recovery (CRi) |
Fulfills all requirements for CR except has persistent neutropenia, anemia, or thrombocytopenia thought to be unrelated to the disease and likely related to drug toxicity. These patients must have a normal bone marrow aspirate and biopsy with no evidence of clonal infiltrates. |
Partial remission (PR) |
At least two of these criteria must be documented: - A decrease in the peripheral absolute lymphocyte count by at least 50% from the level prior to therapy.
- A reduction in previously enlarged nodes by at least 50% with no increase in the size of any single lymph node and no new enlarged lymph nodes. An increase of <25% in a lymph node <1.5 cm is not considered significant.
- A decrease in the size of the liver and/or spleen by at least 50%.
One of the following hematologic parameters must be met in addition to two of the above criteria in order to qualify for a PR: - Platelet count ≥100,000/microL (100 × 109/L) or at least 50% improvement over baseline (if this value was abnormally low at baseline).
- Hemoglobin concentration ≥11 g/dL (110 g/L) or 50% improvement over baseline (if this value was abnormally low at baseline) without red blood cell transfusions or erythropoietin support.
If only one parameter was abnormal before therapy, only one needs to improve to achieve PR. |
Nodular PR |
Persistent bone marrow nodules on bone marrow biopsy in patients achieving a CR or PR. Lymphoid aggregates should be evaluated with immunohistochemistry to determine whether they are comprised of CLL cells, lymphocytes other than CLL cells, or T cells. If nodules are not composed of CLL cells, a CR can be documented provided all other criteria are met. |
Progressive disease (PD)Δ |
At least one of these criteria must be documented: - The appearance of a newly enlarged lymph node (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltration.
- An increase of 50% or more in size of a previously involved site (eg, lymph nodes, spleen, or liver) measuring ≥1.5 cm.
- An increase of 50% or more in the total circulating lymphocyte count with absolute lymphocyte count of 5000/microL (5 × 109/L) or greater.◊
- Richter's transformation documented by lymph node or other tissue biopsy.
- Development of neutropenia, anemia, or thrombocytopenia attributable to CLL.§
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Stable disease |
Patients who do not meet the criteria for a complete remission, partial remission, or progressive disease, have stable disease. Stable disease is therapeutically equivalent to a nonresponse (ie, refractory disease). |