A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
18 Years
N/A
Both
Non-Hodgkin's Lymphoma
Trial Information
A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate (complete and partial response rate)
Principal Investigator
Andreas Engert
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Cologne
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
Ritux plus TNI
NCT ID:
NCT00147953
Start Date:
June 2004
Completion Date:
Related Keywords:
- Non-Hodgkin's Lymphoma
- NHL
- Lymphoma
- Radiotherapy
- Rituximab
- Palliative treatment
- Lymphoma
- Lymphoma, Non-Hodgkin
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