At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Romidepsin + Gemcitabinedrug
Likely dose
Romidepsin + Gemcitabine 12 mg/m2from 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.
Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
In Brief
A Phase 2 clinical trial evaluating Romidepsin + Gemcitabine for Peripheral T-cell Lymphoma. Completed, enrolled 20 participants across 4 sites.
Detailed Summary
Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL (peripheral T-cell lymphoma) in a selected population of patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral T-cell Lymphoma
CountriesItaly
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedApr 2013
Primary CompletionDec 2014
Study CompletionJul 2018
TodayJul 2026
First PostedApr 2, 2013
Enrollment StartJan 1, 2013
Primary CompletionDec 1, 2014
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.3 years ago
Interventions
Romidepsin + Gemcitabinedrug
Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD