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

This study has been completed.
Information provided by:
University of Cologne Identifier:
First received: September 2, 2005
Last updated: January 26, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Rituximab
Procedure: Total nodal irradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Overall response rate (complete and partial response rate)

Secondary Outcome Measures:
  • Toxicity
  • Time to progression
  • Response duration
  • Quality-of-Life

Estimated Enrollment: 30
Study Start Date: June 2004
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00147953

University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Principal Investigator: Andreas Engert University of Cologne
Principal Investigator: R.-P. Mueller University of Cologne
  More Information Identifier: NCT00147953     History of Changes
Other Study ID Numbers: Ritux plus TNI
Study First Received: September 2, 2005
Last Updated: January 26, 2010

Keywords provided by University of Cologne:
Palliative treatment

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 23, 2017