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:
‡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.
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.