Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma

Inclusion Criteria

• •Patients with histologically confirmed PTCL. Biopsy proof of disease at initial diagnosis is mandatory. A biopsy at relapse is preferred but not mandatory.
• •Patients must have received one or two previous regimens of therapy for their disease (salvage chemotherapy plus autologous stem cell transplantation is considered to be one regimen).
• •Clinically and / or radiologically measurable disease (1 site bidimensionally measurable). Measurements / evaluations must be done within 28 days prior to registration.
• •Age 18 to 75 years.
• •ECOG performance status 0, 1 or 2.
• •Life expectancy of ≥ 90 days (3 months).
• •Laboratory Requirements: (must be done within 7 days of registration)
• •Hematology:
• •Granulocytes (AGC) ≥ 1.0 x 10\^9/L
• •Platelets ≥ 75 x 10\^9/L (≥ 50 if bone marrow involvement by lymphoma)
• •Biochemistry:
• •AST and ALT ≤ 2.5x ULN (≤ 5x ULN if hepatic involvement of disease)
• •Serum total bilirubin ≤ 1.5x ULN (≤ 3x ULN if hepatic involvement of disease, or ≤5x ULN if Gilberts Disease)
• •Serum Potassium ≥ 3.8 mmol/L\*
• •* Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 50 mL /min.
• •* Women must be post-menopausal, surgically sterile or use reliable forms of contraception while on study and for 90 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
• •* Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
• •* Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
• •* In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient registration.