Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
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ClinicalTrials.gov Identifier: NCT01728805 |
Recruitment Status :
Completed
First Posted : November 20, 2012
Results First Posted : April 11, 2019
Last Update Posted : April 25, 2024
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Sponsor:
Kyowa Kirin, Inc.
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd. ( Kyowa Kirin, Inc. )
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Tracking Information | ||||
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First Submitted Date ICMJE | October 25, 2012 | |||
First Posted Date ICMJE | November 20, 2012 | |||
Results First Submitted Date ICMJE | October 11, 2018 | |||
Results First Posted Date ICMJE | April 11, 2019 | |||
Last Update Posted Date | April 25, 2024 | |||
Actual Study Start Date ICMJE | November 2012 | |||
Actual Primary Completion Date | March 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] Progression was defined as follows, based on Olsen (2011):
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Original Primary Outcome Measures ICMJE |
Progression free survival [ 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 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL. | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cutaneous T-Cell Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. doi: 10.1016/S1470-2045(18)30379-6. Epub 2018 Aug 9. Erratum In: Lancet Oncol. 2018 Nov;19(11):e581. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
372 | |||
Original Estimated Enrollment ICMJE |
217 | |||
Actual Study Completion Date ICMJE | February 17, 2021 | |||
Actual Primary Completion Date | March 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01728805 | |||
Other Study ID Numbers ICMJE | 0761-010 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Kyowa Kirin Co., Ltd. ( Kyowa Kirin, Inc. ) | |||
Original Responsible Party | Kyowa Hakko Kirin Pharma, Inc. | |||
Current Study Sponsor ICMJE | Kyowa Kirin, Inc. | |||
Original Study Sponsor ICMJE | Kyowa Hakko Kirin Pharma, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Kyowa Kirin Co., Ltd. | |||
Verification Date | April 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |