蕈样真菌病
医学
临床试验
皮肤T细胞淋巴瘤
淋巴瘤
皮肤病科
内科学
作者
Elise A. Olsen,Sean Whittaker,Youn H. Kim,Madeleine Duvic,H. Miles Prince,Stuart R. Lessin,Gary S. Wood,Rein Willemze,Marie‐France Demierre,Nicola Pimpinelli,Maria Grazia Bernengo,Pablo L. Ortiz‐Romero,M. Bagot,Teresa Estrach,Joan Guitart,Robert Knobler,José Antônio Sanches,Keiji Iwatsuki,Makoto Sugaya,Reinhard Dummer
标识
DOI:10.1200/jco.2010.32.0630
摘要
Mycosis fungoides (MF) and Sézary 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.
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