Alemtuzumab in Chronic Lymphocytic Leukemia: A Clinical Practice Guideline

Question 1. Is alemtuzumab a beneficial treatment option, with respect to outcomes such as survival, response rate, response duration, time-to-progression, and quality of life, for patients with B- cell chronic lymphocytic leukemia (CLL)? 2. What toxicities are associated with the use of alemtuzumab? 3. Which patients are more likely, or less likely, to benefit from treatment with alemtuzumab? Target Population This evidence summary applies to adult patients with CLL. Recommendation • Treatment with alemtuzumab is a reasonable option for patients with progressive and symptomatic CLL that is refractory to both alkylator-based and fludarabine-based regimens. Qualifying Statements • The evidence supporting treatment with alemtuzumab comes principally from case-series studies that evaluate disease response as the primary outcome measure. Patients should be informed that any possible beneficial effect of alemtuzumab on other outcome measures such as duration of response, quality of life, and overall survival are not supported in evidence and remain speculative at this time. • Treatment with alemtuzumab is associated with significant and potentially serious adverse treatment-related toxicities. Patients must be carefully informed of the uncertain balance between potential risks of harm and the chance for benefit reported in studies. Given the current substantial uncertainty in this balance, patient preferences will likely play a large role in determining the appropriate treatment choice. • Given the potential toxicities associated with alemtuzumab, and given the limited nature of the clinical trials testing its use in broad populations of patients with CLL, the use of alemtuzumab in patients with important co-morbidities may be associated with excessive risks.