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Chronic%20lymphocytic%20leukemia Management
Follow Up
- Patients should be re-evaluated every 6 months within the 1st year of diagnosis
- For patients with early asymptomatic disease, follow-up at 3-monthly intervals is recommended within the 1st year, then every 3-12 months thereafter depending on 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 (CLL) by the International Workshop Group on CLL (IWCLL)
- Peripheral blood lymphocyte count <4 x 109/L
- Normal blood counts without growth factor support [neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L, hemoglobin (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
- ≥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/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
- Hb concentration ≥11 g/dL or ≥50% improved compared to baseline
- Neutrophil count ≥1.5 x 109/L or >50% improved compared to baseline
- Lymphocyte count, lymphadenopathy, splenomegaly or hepatomegaly increased by 50% from baseline
- Presence of new lesions or transformation to more aggressive forms
- Occurrence of cytopenias contributing to CLL progression (≥2 g/dL Hb and >50% platelet count decreased from baseline)
- Detects malignant clones by flow cytometry or quantitative polymerase chain reaction
- Most important predictor of overall survival and progression-free survival after chemoimmunotherapy
Maintenance Therapy
- Treatment with Lenalidomide after completion of initial therapy may be considered for high-risk CLL patients without del(17p)/TP53 mutation (MRD ≥10-2 or ≥10-4 and <10-2 with unmutated IGHV)
- Treatment with Lenalidomide or Ofatumumab may be considered in CLL patients with refractory/relapsed disease with complete or partial response after completion of 2nd-line therapy
- For patients previously treated with Ibrutinib being considered for Acalabrutinib treatment, Bruton's tyrosine kinase (BTK) mutation analysis should be considered; BTK mutation-positive patients may be unresponsive to Acalabrutinib therapy
Second-line and Subsequent Therapy
- Relapsed disease occurs when disease progression appears ≥6 months after initial complete or partial response
- Refractory disease is when a patient fails to achieve a response or disease progression occurs within 6 months of the last treatment dose
Second-line and Subsequent Therapy
- Depends on the presence of del(17p)/TP53 mutation, patient’s age, and presence of comorbidities
- Patients without del(17p)/TP53 mutation, ≥65 years old or <65 years old with significant comorbidities
- Acalabrutinib1
- Dose-dense Rituximab4
- Duvelisib2
- High-dose Methylprednisolone (HDMP) + Rituximab or Obinutuzumab3
- Ibrutinib1
- Idelalisib ± Rituximab2
- Lenalidomide ± Rituximab2
- Obinutuzumab2
- Ofatumumab2
- Rituximab + Bendamustine3
- Rituximab + Chlorambucil2
- Venetoclax2
- Venetoclax + Rituximab1
- Zanubrutinib2
- CLL without del(17p)/TP53 mutation <65 years old without significant comorbidities
- Acalabrutinib1
- Alemtuzumab ± Rituximab4
- Bendamustine + Rituximab2
- Bendamustine, Rituximab + Ibrutinib4
- Duvelisib2
- Ibrutinib1
- Idelalisib ± Rituximab2
- FC + Ofatumumab4
- FCR2 (Fludarabine, Cyclophosphamide, Rituximab)
- HDMP + Rituximab or Obinutuzumab3
- Lenalidomide ± Rituximab2
- Obinutuzumab2
- Ofatumumab2
- Venetoclax2
- Venetoclax + Rituximab1
- Zanubrutinib2
- CLL with del(17p)/TP53 mutation
- Acalabrutinib1
- Alemtuzumab ± Rituximab4
- Duvelisib2
- HDMP + Rituximab
- Ibrutinib1
- Idelalisib ± Rituximab2
- Lenalidomide ± Rituximab2
- Ofatumumab2,5
- Venetoclax2
- Venetoclax + Rituximab1
- Zanubrutinib2
1Indicated as Category 1 by the National Comprehensive Cancer Network (NCCN).
2Indicated as Category 2A by the NCCN.
3Indicated as Category 2B by the NCCN.
4Indicated as Category 3 by the NCCN.
5Not recommended for patients with lymph nodes >5 cm.
