At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
Romidepsindrug
Likely dose
Not stated in 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.
A Japanese Phase 1/2, Multicenter, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Romidepsin in Subjects With the Progressive or Relapsed Peripheral T-cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Romidepsin for Lymphoma, T-cell, Peripheral. Completed, enrolled 51 participants across 17 sites.
Detailed Summary
The purpose of the study was to assess efficacy, tolerability, safety and pharmacokinetics of Romidepsin in subjects with progressive or relapsed peripheral T-cell lymphoma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, T-cell, Peripheral
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartDec 2011
Primary CompletionJul 2015
Study CompletionDec 2018
TodayJul 2026
First PostedOct 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionJul 28, 2015
Study CompletionDec 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.7 years ago
Interventions
Romidepsindrug
Intravenous dosing for 4 hours on Days 1, 8, and 15 of each 28-day cycle