When to initiate treatment for CLL1

Recommendation to initiate therapy

  General Practice Clinical Trial
Rai stage 0 or Binet stage A Not generally indicated* Research question
Rai stage I/II or Binet stage B Possible* Possible*
Rai stage III/IV or Binet stage C Yes Yes
Active or progressive disease Yes Yes
Without active or progressive disease No Research question

*Treatment is indicated if the disease is symptomatic or progressive, as defined below.
Anemia and/or thrombocytopenia from CLL-unrelated causes should be excluded.
Adapted from Hallek M, Cheson BD, Catovsky D, et al. Blood. 2018;131(25):2745-2760.

Treatment in early-stage disease is not indicated1

  • In general practice, patients with asymptomatic early-stage disease should be monitored and not treated unless their disease progresses or develops symptoms

Second- and subsequent-line treatment decisions should generally follow the same indications as for first-line treatment1

Criteria for active disease1

  • Treatment is indicated when a patient develops symptomatic or progressive disease (summarized as “active disease”). Active disease should be clearly documented to initiate therapy. At least 1 of the following criteria should be met:

Bone marrow
  • Development or worsening of anemia and/or thrombocytopenia
  • Platelet counts <100 x 109/L may remain stable over a long period
    • Does not automatically require therapeutic intervention
  • Spleen ≥6 cm below the left costal margin or progressive or symptomatic splenomegaly
Lymph nodes
  • Nodes ≥10 cm in longest diameter or progressive or symptomatic lymphadenopathy
  • Progressive lymphocytosis: increase ≥50% over a 2-month period, or lymphocyte doubling time (LDT) <6 months
    • Obtained by extrapolation of absolute lymphocyte count
    • Exclude factors contributing to lymphocytosis other than CLL (eg, infection, steroid administration)
  • Disease-related symptom as defined by any of the following:
    • Unintentional weight loss of ≥10% within the previous 6 months
    • Significant fatigue
    • Fevers ≥100.5°F or 38.0°C for ≥2 weeks without evidence of infection
    • Night sweats for ≥1 month without evidence of infection
  • Autoimmune complications, poorly responsive to steroids
  • Symptomatic or functional extranodal involvement

Patients with initial blood lymphocyte counts <30,000/µL may require a longer observation period to determine doubling time.

  • Patients with CLL may present with a markedly elevated leukocyte count; however, leukostasis rarely occurs in patients with CLL. Therefore, the absolute lymphocyte count should not be used as the sole indicator for treatment

CLL=chronic lymphocytic leukemia, LDT=lymphocyte doubling time, ECOG PS, Eastern Cooperative Oncology Group performance status

Importance of biomarkers in CLL

Clinical research has identified cytogenetic biomarkers in CLL that can help inform prognosis
and therapy choices.

About these biomarkers

Reference: 1. 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(25):2745-2760.

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