Content on this page:
Content on this page:
Monitoring
Patients should be re-evaluated every 6 months within
the first year of diagnosis. For patients with early asymptomatic disease,
follow-up at 3-month intervals is recommended within the first year, then every
3-12 months thereafter depending on the patient’s status.
Physical examination and blood exams are used for
assessment of treatment response. Bone marrow biopsy and aspirate should be
conducted on patients in clinical trials.
Response Criteria for Chronic
Lymphocytic Leukemia by the International Workshop Group on Chronic Lymphocytic
Leukemia (IWCLL)
A complete response should include all of the
following, at least 2 months after treatment completion:
- Normal peripheral blood lymphocyte count
- Normal blood counts without growth factor support (neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L, Hb ≥11 g/dL
- No enlarged lymph nodes (≥1.5 cm in diameter)
- No splenomegaly or hepatomegaly
- No CLL-related constitutional symptoms (eg weight loss, fever, night sweats)
- Bone marrow is normocellular for age without typical CLL lymphocytes and B-lymphoid nodules
Partial response criteria include:
- ≥2 of the following within
2 months after completion of therapy:
- ≥50% reduced peripheral blood lymphocyte count compared to baseline
- ≥50% reduced lymphadenopathy compared to baseline
- ≥50% reduction in liver or spleen size if previously enlarged in baseline findings
- ≥1 of the blood count
normalized or increased by ≥50% prior to treatment initiation:
- Platelet count ≥100 x 109/L or ≥50% improved compared to baseline
- Hemoglobin (Hb) concentration ≥11 g/dL or ≥50% improved compared to baseline
- Neutrophil count ≥1.5 x 109/L or >50% improved compared to baseline
- Presence of CLL cells and B-lymphoid nodules in bone marrow
Disease progression involves ≥1 of the following:
- Lymphocyte count, lymphadenopathy, splenomegaly, or hepatomegaly increased by ≥50% from baseline
- Presence of new lesions or transformation to more aggressive forms
- Occurrence of cytopenia contributing to CLL progression (≥2 g/dL Hb and ≥50% platelet count decreased from baseline)
- Increase in CLL cells by ≥50% on successive bone marrow biopsies
Stable disease is defined as a disease without
complete or partial response but without disease progression.
Minimal residual disease (MRD) is detected as malignant clones by flow
cytometry or quantitative polymerase chain reaction. It is the most important
predictor of overall survival and progression-free survival after
chemoimmunotherapy.