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

Not Recruiting

Trial ID: NCT01728805


The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

Official Title

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology


Inclusion Criteria:

   - Male and female subjects ≥ 18 years of age at the time of enrollment, except in Japan
   where subjects must be ≥ 20 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 had failed at least one prior course of systemic therapy. Psoralen plus
   ultraviolet light therapy (PUVA) is not considered to be a systemic therapy

   - Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study

   - 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 were eligible
   provided their CD4+ cell counts were ≥ 200/mm3

   - Subjects with mycosis fungoides (MF) and a known history of non-complicated
   staphylococcus infection/colonization were eligible provided they continued to receive
   stable doses of prophylactic antibiotics

   - Women of childbearing potential (WOCBP) must have had a negative pregnancy test within
   7 days of receiving study medication

   - WOCBP and male subjects as well as their female partners of childbearing potential
   must have agreed to use effective contraception throughout the study and for 3 months
   after the last dose of KW-0761

Exclusion Criteria:

   - Prior treatment with KW-0761 or vorinostat.

   - Large cell transformation. However, subjects with a history of LCT but without current
   aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes
   would be eligible.

   - Diagnosed with 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 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular
   carcinoma in situ of the breast within the past two years could enroll as long as
   there was no current evidence of disease.

   - Clinical evidence of central nervous system (CNS) metastasis.

   - Psychiatric illness, disability or social situation that would have compromised the
   subject's safety or ability to provide consent, or limited compliance with study

   - Significant uncontrolled intercurrent illness

   - Known or tested 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 had no active signs of
   active infection, and whose last active infection was more than 6 months ago, could
   enter the study, and should have continued 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 were excluded. (For example, Grave's disease; systemic
   lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).

   - Was pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.

   - History of allogeneic transplant.


biological: KW-0761

drug: Vorinostat

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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