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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/10/2018
Start Date:November 2012
End Date:December 2018

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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

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

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, 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 have 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
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 as well as their female partners of childbearing potential
must agree to use effective contraception throughout the study and for 6 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 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.
We found this trial at
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Seattle, Washington 98104
(206) 543-2100
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Aurora, Colorado 80045
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450 Brookline Ave
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303 East Superior Street
Chicago, Illinois 60611
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
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Fairport, New York 14450
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Gilbert, Arizona 85234
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Houston, Texas 77030
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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757 Westwood Plaza
Los Angeles, California 90024
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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New Orleans, Louisiana 70112
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New York, New York 10032
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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Pittsburgh, Pennsylvania 15261
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Rochester, New York 14642
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Winston-Salem, North Carolina 27157
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