|Canadian Cancer Trials Group LY.15 - 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 - was centrally activated on April 30, 2013.
The objectives of this trial are to:
Up to 24 people will take part in this study. The study should take 2 years to complete and the results should be known in about 4 years.
- Evaluate the safety and feasibility of the combination of gemcitabine, dexamethasone and cisplatin (GDP) and romidepsin in relapsed/refractory aggressive lymphomas (including PTCL and DLBCL);
- Identify the maximum tolerated doses of romidepsin, gemcitabine, dexamethasone and cisplatin used in combination;
- Evaluate preliminary evidence of anti-tumour activity; and,
- Establish a recommended phase II dose of romidepsin to be given in combination with GDP in a planned randomized phase II trial in newly diagnosed untreated PTCL.