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Open Access 01-12-2016 | Research

A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients

Authors: Cinzia Pellegrini, Anna Dodero, Annalisa Chiappella, Federico Monaco, Debora Degl’Innocenti, Flavia Salvi, Umberto Vitolo, Lisa Argnani, Paolo Corradini, Pier Luigi Zinzani, On behalf of the Italian Lymphoma Foundation (Fondazione Italiana Linfomi Onlus, FIL)

Published in: Journal of Hematology & Oncology | Issue 1/2016

Abstract

Background

There is no consensus regarding optimal treatment for peripheral T-cell lymphomas (PTCL), especially in relapsed or refractory cases, which have very poor prognosis and a dismal outcome, with 5-year overall survival of 30 %.

Methods

A multicenter prospective phase II trial was conducted to investigate the role of the combination of gemcitabine plus romidepsin (GEMRO regimen) in relapsed/refractory PTCL, looking for a potential synergistic effect of the two drugs. GEMRO regimen contemplates an induction with romidepsin plus gemcitabine for six 28-day cycles followed by maintenance with romidepsin for patients in at least partial remission. The primary endpoint was the overall response rate (ORR); secondary endpoints were survival, duration of response, and safety of the regimen.

Results

The ORR was 30 % (6/20) with 15 % (3) complete response (CR) rate. Two-year overall survival was 50 % and progression-free survival 11.2 %. Grade ≥3 adverse events were represented by thrombocytopenia (60 %), neutropenia (50 %), and anemia (20 %). Two patients are still in CR with median response duration of 18 months. The majority of non-hematological toxicities were mild and transient. No treatment-related death occurred and no toxicity led to treatment interruption.

Conclusions

GEMRO combination regimen shows efficacy data similar to those of single-agent romidepsin with additional hematologic toxicities. Synergy observed in preclinical phase did not turn into ability to improve clinical outcomes.

Trial registration

The trial was registered under EudraCT 2012-001404-38; ClinicalTrials.gov number, NCT01822886.

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Title: A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients
Authors: Cinzia Pellegrini
Anna Dodero
Annalisa Chiappella
Federico Monaco
Debora Degl’Innocenti
Flavia Salvi
Umberto Vitolo
Lisa Argnani
Paolo Corradini
Pier Luigi Zinzani
On behalf of the Italian Lymphoma Foundation (Fondazione Italiana Linfomi Onlus, FIL)
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Journal of Hematology & Oncology / Issue 1/2016
Electronic ISSN: 1756-8722
DOI: https://doi.org/10.1186/s13045-016-0266-1

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Background

Methods

Results

Conclusions

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