A Phase I Study Of Romidepsin, Gemcitabine, Dexamethasone And Cisplatin Combination Therapy In The Treatment Of Peripheral T-Cell And Diffuse Large B-Cell Lymphoma; The Canadian Cancer Trials Group Ly.15 Study Dagger

We investigated GDP (gemcitabine, 1000 mg/m(2) IV d1, d8; dexamethasone, 40 mg po d1-4; cisplatin, 75 mg/m(2) IV d1) combined with romidepsin on days 1 and 8 every 21 days to a maximum of six cycles in a standard 3 + 3, phase I dose escalation trial for patients with relapsed/refractory peripheral T-cell (PTCL) or diffuse large B-cell (DLBCL) lymphoma (NCT01846390). After treating four patients, gemcitabine and romidepsin were given on days 1 and 15 every 28 days. On the 21-day schedule at 6 mg/m(2) romidepsin, there were three dose-limiting toxicities (DLTs) among four patients. On the 28-day schedule, there were no DLTs at the 6, 8, or 10 mg/m(2) dose. At 12 mg/m(2), there were four observed grade 3 DLTs among six evaluable patients. Full doses of GDP can be combined with a recommended phase II romidepsin dose of 10 mg/m(2) if given on a day 1, 15 every 28 days schedule.