Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.

The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Inclusion Criteria:

• B-cell non-Hodgkin's lymphoma
• At least one prior antitumor therapy
• ECOG performance status 0-2
• No major organ dysfunction
• Written informed consent

Exclusion Criteria:

• The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma