Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSPOLSEN, Elise A.WHITTAKER, SeanKIM, Youn H.DUVIC, MadeleinePRINCE, H. MilesLESSIN, Stuart R.WOOD, Gary S.WILLEMZE, ReinDEMIERRE, Marie-FrancePIMPINELLI, NicolaBERNENGO, Maria GraziaORTIZ-ROMERO, Pablo L.BAGOT, MartineESTRACH, TeresaGUITART, JoanKNOBLER, RobertSANCHES, Jose AntonioIWATSUKI, KeijiSUGAYA, MakotoDUMMER, ReinhardPITTELKOW, MarkHOPPE, RichardPARKER, SareetaGESKIN, LarisaPINTER-BROWN, LaurenGIRARDI, MichaelBURG, GuenterRANKI, AnnamariVERMEER, MaartanHORWITZ, StevenHEALD, PeterROSEN, SteveCERRONI, LorenzoDRENO, BrigetteVONDERHEID, Eric C.2017-11-272017-11-272011JOURNAL OF CLINICAL ONCOLOGY, v.29, n.18, p.2598-2607, 20110732-183Xhttps://observatorio.fm.usp.br/handle/OPI/22927Mycosis 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 OncologyengrestrictedAccesst-cell lymphomaof-life measureperipheral-bloodexpressiondiseaseclassificationdiagnosisphasetrialidentificationarticleCopyright AMER SOC CLINICAL ONCOLOGY10.1200/JCO.2010.32.0630Oncology