Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 29, Issue 18, Pages 2598-2607Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2010.32.0630
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Funding
- BioCryst
- Eisai
- Johnson Johnson
- Yaupon Therapeutics
- Genmab
- Gloucester Pharmaceuticals
- Merck
- Allos Therapeutics
- Eli Lilly
- TenX Biopharma
- Therakos
- Roche
- Novartis
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Mycosis fungoides (MF) and Sezary syndrome (SS), the major forms of cutaneous T-cell lymphoma, have unique characteristics that distinguish them from other types of non-Hodgkin's lymphomas. Clinical trials in MF/SS have suffered from a lack of standardization in evaluation, staging, assessment, end points, and response criteria. Recently defined criteria for the diagnosis of early MF, guidelines for initial evaluation, and revised staging and classification criteria for MF and SS now offer the potential for uniform staging of patients enrolled in clinical trials for MF/SS. This article presents consensus recommendations for the general conduct of clinical trials of patients with MF/SS as well as methods for standardized assessment of potential disease manifestations in skin, lymph nodes, blood, and visceral organs, and definition of end points and response criteria. These guidelines should facilitate collaboration among investigators and collation of data from sponsor-generated or investigator-initiated clinical trials involving patients with MF or SS. J Clin Oncol 29:2598-2607. (C) 2011 by American Society of Clinical Oncology
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