- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728805
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
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Victoria
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Melbourne, Victoria, Australia, 3000
- Parkville Cancer Clinical Trials Unit
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Aarhus, Denmark, 8000
- Aarhus University Hospital
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Nantes, France, 44093
- CHU de Nantes
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Paris, France, 75010
- Hôpital Saint Louis
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Pessac, France, 33604
- CHU Bordeaux - Hôpital Haut-Lévêque
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Pierre-Benite Cedex, France, 69495
- Centre Hospitalier Lyon Sud
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Mannheim, Germany, D-68167
- University Medical Centre Mannheim
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Muenster, Germany, 48149
- University Hospital Muenster
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Bologna, Italy, 40138
- Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna
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Turin, Italy, 10124
- Università degli studi di Torino
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Aichi
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Nagoya-shi, Aichi, Japan, 467-8602
- Nagoya City University Hospital
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Fukushima
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Fukushima-shi, Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Gunma
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Maebashi-shi, Gunma, Japan, 371-8511
- Gunma University Hospital
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hokkaido
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Asahikawa, Hokkaido, Japan, 078-8510
- Asahikawa Medical University Hospital
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 890-0064
- Imamura Bun-in Hospital
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Kanagawa
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Yokohama-shi, Kanagawa, Japan, 236-0004
- Yokohama City University Hospital
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Kochi
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Nankoku-shi, Kochi, Japan, 783-8505
- Kochi Medical School Hospital
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Mie
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Tsu-shi, Mie, Japan, 514-8507
- Mie University Hospital
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Miyagi
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Sendai-shi, Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Nagano
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Matsumoto-shi, Nagano, Japan, 390-8621
- Shinshu University Hospital
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Okayama
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Okayama-shi, Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka
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Hirakata-shi, Osaka, Japan, 571-1191
- Kansai Medical University Hospital
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Suita-shi, Osaka, Japan, 565-0871
- Osaka University Hospital
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Shizuoka
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Hamamatsu-shi, Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8655
- The University of Tokyo Hospital
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Fuchu-shi, Tokyo, Japan, 183-8524
- Tokyo Metropolitan Tama Medical Center
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Koto-ku, Tokyo, Japan, 135-8550
- Japanese Foundation for Cancer Research
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Leiden, Netherlands, 2300RC
- Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Salamanca, Spain, 37007
- Hospital Universitario de Salamanca
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Zurich, Switzerland, 8091
- University Hospital Zurich
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Birmingham, United Kingdom, B15 2TH
- University Hospital Birmingham
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London, United Kingdom, SE1 7EH
- Guys & St. Thomas NHS Trust
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M20 4BX
- The Christie Hospital Foundation NHS Trust
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama - Birmingham
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Arizona
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Gilbert, Arizona, United States, 85234
- Banner MD Anderson
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California
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Duarte, California, United States, 91010
- City of Hope National Medical Center
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Los Angeles, California, United States, 90095
- UCLA Medical Center
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Stanford, California, United States, 94305
- Stanford Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University School of Medicine - Yale Cancer Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30322
- The Winship Cancer Institute (Emory University)
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Kansas
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Westwood, Kansas, United States, 66205
- University of Kansas Cancer Center
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Boston, Massachusetts, United States, 02118
- Boston Medical Center, Department of Medicine, Section of Hem/Onc
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
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New York
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Fairport, New York, United States, 14450
- Universal Dermatology, PLLC
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10037
- Columbia Presbyterian
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Rochester, New York, United States, 14642
- University of Rochester School of Medicine
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Columbus, Ohio, United States, 43210
- Ohio State University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, United States, 15208
- University of Pittsburgh School of Medicine
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, United States, 77030
- M.D.Anderson Cancer Center
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98109
- University of Washington
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Wisconsin
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Milwaukee, Wisconsin, United States, 53266
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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 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 requirements.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: KW-0761
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
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1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Other Names:
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Active Comparator: Vorinostat
vorinostat 400 mg once daily
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression Free Survival
Time Frame: From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
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Progression was defined as follows, based on Olsen (2011):
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From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Response Rate
Time Frame: at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months
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The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later.
Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.
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at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months
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Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
Time Frame: Cycle 1, 3, and 5
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LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate. |
Cycle 1, 3, and 5
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Pruritis Evaluation
Time Frame: Cycle 1, 3, and 5
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The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life. LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate. |
Cycle 1, 3, and 5
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dmitri O. Grebennik, MD, Kyowa Kirin, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, T-Cell, Cutaneous
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Histone Deacetylase Inhibitors
- Vorinostat
- Mogamulizumab
Other Study ID Numbers
- 0761-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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