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Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia

Michael Hallek, Bruce D. Cheson, Daniel Catovsky, Federico Caligaris-Cappio, Guillermo Dighiero, Hartmut Döhner, Peter Hillmen, Michael Keating, Emili Montserrat, Nicholas Chiorazzi, Stephan Stilgenbauer, Kanti R. Rai, John C. Byrd, Barbara Eichhorst, Susan O'Brien, Tadeusz Robak, John F. Seymour and Thomas J. Kipps

Abstract

In 2008, International Workshop on CLL (iwCLL) published consensus guidelines for the design and conduct of clinical trials for patients with chronic lymphocytic leukemia (CLL) that were revised from those previously published by the National Cancer Institute-sponsored Working Group. These guidelines provided definitions intended to standardize the assessment of patients that were adopted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the evaluation of new drugs. Since the publication of these guidelines there have been major advances in the biology and treatment of patients with CLL, prompting the iwCLL to evaluate and revise the 2008 criteria.

  • Submitted September 18, 2017.
  • Accepted March 7, 2018.