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

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: dexamethasone; Drug: gemcitabine; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00491127

B9E-XM-S315

6899

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)