Canadian Cancer Trials Group Bulletins

Trial Management Group

Trial Activation

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:

  1. 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);

  2. Identify the maximum tolerated doses of romidepsin, gemcitabine, dexamethasone and cisplatin used in combination;

  3. Evaluate preliminary evidence of anti-tumour activity; and,

  4. 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.

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.