Non-Hodgkin's Lymphoma
Conditions
Keywords
NHL, Lymphoma, Radiotherapy, Rituximab, Palliative treatment
Brief summary
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.
Detailed description
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.
Interventions
DRUGRituximab
PROCEDURETotal nodal irradiation
Sponsors
University of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (complete and partial response rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
| Time to progression | — |
| Response duration | — |
| Quality-of-Life | — |
Countries
Germany
Outcome results
None listed