Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma

Phase II Study of Cisplatin With Gemcitabine in Fixed Dose Rate Infusion and Dexamethasone in Second-Line in Patients With Aggressive Non-Hodgkin's Lymphoma

The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines.

Inclusion Criteria:

• The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification:

  • Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma)
  • Peripheral T-cell lymphoma
  • Anaplastic lymphoma of large T-cells /null cells

• Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible.

• ECOG PS (performance status) less than or equal to 2

• Presence of bidimensionally measurable disease in accordance with WHO criteria.

Exclusion Criteria:

• Involvement of the CNS.
• Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin.
• Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma.
• Active infection (in the opinion of the investigator).