At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 372 enrolled
Drug / intervention
KW-0761 +1 morebiological
Likely dose
KW-0761 1.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating KW-0761 and Vorinostat for Cutaneous T-Cell Lymphoma. Completed, enrolled 372 participants across 73 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous T-Cell Lymphoma
CountriesAustralia, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionMar 2017
Study CompletionFeb 2021
TodayJul 2026
First PostedNov 20, 2012
Enrollment StartNov 1, 2012
Primary CompletionMar 1, 2017
Study CompletionFeb 17, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.6 years ago
Interventions
KW-0761biological
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Vorinostatdrug