Initial Safety Report Finds Acceptable Safety With Ibrutinib for Asymptomatic, High-Risk CLL

[AussieNeil]

"Initial findings from the CLL12 trial on the use of ibrutinib in the treatment of chronic lymphocytic leukemia (CLL) in asymptomatic patients at risk of disease progression found risks in using the agent to be acceptable. The German CLL Study Group conducted the trial, whose findings were presented by Petra Langerbeins, MD, of the University of Cologne, at the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), in Sydney, Australia.

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This study used a comprehensive prognostic score to identify patients whose early stage, asymptomatic CLL was at risk for disease progression. It is the first prospective, placebo-controlled, double-blind, phase 3 trial to investigate if ibrutinib improves event-free survival in asymptomatic patients with early stage CLL.

Asymptomatic CLL was classified as intermediate, high, or very-high risk and patients were randomized one-to-one to receive ibrutinib 420 mg daily or placebo on 28 day cycles.

Among the 266 patients screened, nine (3.4%) had the del17p mutation, and 24 (9.0%) had the del11q mutation. Both mutations are associated with poor outcomes, but the del17p mutation renders the disease unresponsive to chemotherapy with a dire prognosis for patients. However, the CLL subtype responds to treatment with ibrutinib as well as idelalisib, another novel oral kinase inhibitor. "

From Oncology Nurse Advisor:

oncologynurseadvisor.com/le...

Neil

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