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 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
- 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.
- 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
- Active infection (in the opinion of the investigator).