Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Inclusion Criteria:

• Males and female subjects > 18 years of age at the time of enrollment
• Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
• Stage IB, II-A, II-B, III and IV
• Subjects who have progressed following at least one prior course of systemic therapy

• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤

  1 at study entry

• Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
• Adequate hematological, renal and hepatic function
• Subjects previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are > 200/mm3
• Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
• Women of childbearing potential(WOCBP)must have a negative pregnancy test within 7 days of receiving study medication
• WOCBP and male subjects and their female partners of child bearing potential must agree to use effective contraception throughout the study

Exclusion Criteria:

• Transformed MF
• Have had a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of <0.1 µg/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast with in the past two years may enroll as long as there is no current evidence of disease.
• Clinical evidence of central nervous system (CNS) metastasis.
• Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
• Significant uncontrolled intercurrent illness
• Known or tests positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
• Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and have no active signs of active infection, and whose last active infection was more than 6 months ago, may enter the study, and should continue to take the prescribed medication for the duration of the study.
• Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
• Known active autoimmune disease will be excluded. (For example; Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
• Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.