NCT01822886

Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients

Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Romidepsin + Gemcitabine	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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-12-01
• Completion: 2018-07-01
• First posted: 2013-04-02
• Last updated: 2019-10-14
• Results posted: 2019-10-10

Locations

4 sites across 1 country: Italy