test

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

Conditions

Non-Hodgkin's Lymphoma

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

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


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

- Males 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)
within 3 months of the Pre treatment Visit

- 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:

- Prior treatment with KW-0761 or vorinostat.

- Large cell transformation.

- 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
ng/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 [ß-HCG]) or lactating.

Sponsor:
Kyowa Hakko Kirin Co., Ltd.
Dates:
05/08/2014
Last Updated:
Study HIC#:
1212011230