Abstract

In our present summary of key features of recent RCTs, we focus on chronic lymphatic leukemia. Four recently published trials in patients with chronic lymphocytic leukemia (CLL) are presented in detail: three examine different therapeutic options for first-line therapy for CLL and one addresses the role of oblimersen sodium (Bcl-2 antisense) as an addition to cyclophosphamide and fludarabine. In lesser detail, we present the results of three other interesting trials published during the 9-month period. After a short overview of the clinical relevance and the selection of patients for these trials, we discuss important methodologic aspects of each trial, eg, randomization, loss to follow-up, dropout rate, and statistical analysis. We also discuss the results of the primary efficacy endpoints and the methods used to report health-related quality of life. The main objective of this summary report is to provide the knowledge in a way that busy practitioners can easily interpret it. Published Trials in Patients With CLL CLL is a chronic disease of the B-cell lineage that is characterized by an accumulation of ineffective lymphocytes. Because early treatment is not associated with increased length of survival, treatment is reserved for patients with clinical symptoms or rapidly progressing disease. CLL is staged according to the Binet criteria or Rai’s criteria, both of which are based on the number of lymphatic sites or organs (liver, spleen) affected as

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