At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 131 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 Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy (GPI-06-0002)
In Brief
A Phase 2 clinical trial evaluating Romidepsin for Peripheral T-cell Lymphoma. Completed, enrolled 131 participants across 90 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral T-cell Lymphoma
CountriesAustralia, Czechia, France, Germany, Poland, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartJun 2007
Primary CompletionNov 2010
Study CompletionMay 2018
TodayJul 2026
First PostedJan 25, 2007
Enrollment StartJun 19, 2007
Primary CompletionNov 11, 2010
Study CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.4 years ago
Interventions
Romidepsindrug
Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.