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

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine

Criteria

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).