This is a phase II, non-randomized, open-label, single-arm trial that is being conducted in North America and Europe. The purpose of this study is to evaluate the role of investigational drug forodesine [(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-imino-D-ribitol hydrochloride] in the treatment of CTCL with Stage IB-IVA  refractory to standard therapy. Forodesine is an analog inhibitor of the enzyme purine nucleoside phosphorylase (PNP). PNP inhibitors specifically target T-cells causing selective suppression of  T-cells and, thus, may provide a new treatment for T-cell malignancies, such as CTCL.

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Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma

This is a multi-center, multinational, open-label, non-randomized, single-agent phase II study with oral LBH589 in adult patients with Stage IB-IVA CTCL refractory to standard therapy. LBH589 is an orally-administered histone deacetylase (HDAC) inhibitor belonging to a structurally novel cinnamic hydroxamic acid class of compounds. Histone deacetylases (HDACs) act on chromatin and on transcription factors, and modulate gene regulation including the function of the tumor suppressor genes p53.