IWCLL 2018: Response criteria for CLL clinical trials. Note: Marrow assessment is typically required for a formal Complete Response (CR).
Full Remission Factors (CR)
Partial Reductions (PR)
Final Response Assessment
No Response
Does not meet standardized criteria for CR or PR. If growing, consider Progressive Disease (PD).
Guidelines & Evidence
Clinical Details
Section 1
When to Use
When to Use
Assessing treatment response in patients with Chronic Lymphocytic Leukemia (CLL) following chemotherapy or targeted therapy.
Standardizing response reporting in clinical trials.
Evaluating the depth of nodes, marrow, and blood-based remission.
Patient Population
Patients with confirmed CLL participating in clinical trials or undergoing intensive therapy. (Note: in clinical practice, simpler assessment of blood counts and nodes is often sufficient).
When Not to Rely on This Score Alone
MRD status — IWCLL criteria define clinical response; molecular response (MRD) is a separate, more sensitive endpoint.
Initial diagnosis — use WHO criteria and flow cytometry for diagnosis, not response criteria.
Section 2
Formula & Logic
Complete Response (CR)
Absence of lymphadenopathy (all nodes ≤ 1.5 cm).
No splenomegaly or hepatomegaly.
Absence of constitutional symptoms.
ANC ≥ 1.5 × 10⁹/L.
Platelets ≥ 100 × 10⁹/L.
Haemoglobin ≥ 11.0 g/dL (un-transfused).
Marrow: < 30% lymphocytes and no nodules (only required in trials).
Partial Response (PR)
≥ 50% decrease in ALC.
≥ 50% decrease in lymphadenopathy sum of product diameters (SPD).
≥ 50% decrease in liver or spleen size.
Haemopoietic improvement (ANC/Plt/Hb) OR ≥ 50% increase over baseline.
Section 3
Pearls/Pitfalls
Targeted Therapies (BTKi)
With B-cell receptor inhibitors (e.g., Ibrutinib), patients often develop a transient "redistribution lymphocytosis". In the 2018 guidelines, lymphocytosis alone does not preclude a PR if other criteria (nodes/spleen) are met.
Section 4
Evidence Appraisal
Primary Consensus
iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL.
Developed by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) to update the 2008 NCI/IWG guidelines, specifically addressing novel targeted therapies and the role of MRD.