Know Cancer

forgot password

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

Phase 3
18 Years
Open (Enrolling)
Cutaneous T-Cell Lymphoma

Thank you

Trial Information

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

Phase 3 randomized study to compare the progression free survival of subjects with
relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects
who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Safety Issue:


Principal Investigator

Michael Kurman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

September 2015

Related Keywords:

  • Cutaneous T-cell Lymphoma
  • Cutaneous T-Cell Lymphoma (CTCL)
  • myocis fungoides (MF)
  • Sezary Syndrome (SS)
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



Memorial Sloan Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Rush University Medical Center Chicago, Illinois  60612-3824
University of Colorado Denver, Colorado  80217
University of Rochester School of Medicine Rochester, New York  14642
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Tulane University Medical Center New Orleans, Louisiana  70112
University of Washington Seattle, Washington  98195
University of Pennsylvania Philadelphia, Pennsylvania  19104
Northwestern University Chicago, Illinois  60611
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Cleveland Clinic Cleveland, Ohio  44195
UCLA Medical Center Los Angeles, California  90095-7059
Ohio State University Columbus, Ohio  43210
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
Indiana University Indianapolis, Indiana  46202
Stanford Medical Center Stanford, California  94303
Columbia Presbyterian New York City, New York  10032
M.D.Anderson Cancer Center Houston, Texas  77030
University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania  15232
University of Alabama - Birmingham Birmingham, Alabama  35294
Yale University School of Medicine - Yale Cancer Center New Haven, Connecticut  06520
The Winship Cancer Institute (Emory University) Atlanta, Georgia  30322