Abstract
We investigated GDP (gemcitabine, 1000 mg/m2 IV d1, d8; dexamethasone, 40 mg po d1-4; cisplatin, 75 mg/m2 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/m2 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/m2 dose. At 12 mg/m2, 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/m2 if given on a day 1, 15 every 28 days schedule.
Keywords:
Non-Hodgkin lymphoma; combination therapy; phase I trial; romidepsin.
Publication types
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Clinical Trial, Phase I
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Aged
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Aged, 80 and over
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Canada
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Cisplatin / adverse effects
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Cisplatin / therapeutic use
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Deoxycytidine / adverse effects
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Deoxycytidine / analogs & derivatives*
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Deoxycytidine / therapeutic use
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Depsipeptides / administration & dosage*
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Depsipeptides / adverse effects
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Dexamethasone / adverse effects
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Dexamethasone / therapeutic use
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Female
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Humans
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Lymphoma, Large B-Cell, Diffuse / diagnosis
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Lymphoma, Large B-Cell, Diffuse / drug therapy*
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Lymphoma, Large B-Cell, Diffuse / mortality
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Lymphoma, T-Cell, Peripheral / diagnosis
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Lymphoma, T-Cell, Peripheral / drug therapy*
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Lymphoma, T-Cell, Peripheral / mortality
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Male
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Middle Aged
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Prognosis
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Treatment Outcome
Substances
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Depsipeptides
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Deoxycytidine
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Dexamethasone
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romidepsin
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Cisplatin