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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

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ClinicalTrials.gov Identifier: NCT00147953
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : January 27, 2010
Sponsor:
Information provided by:
University of Cologne

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Toxicity
  2. Time to progression
  3. Response duration
  4. Quality-of-Life


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147953


Locations
Germany
University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert University of Cologne
Principal Investigator: R.-P. Mueller University of Cologne

ClinicalTrials.gov Identifier: NCT00147953     History of Changes
Other Study ID Numbers: Ritux plus TNI
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: January 2010

Keywords provided by University of Cologne:
NHL
Lymphoma
Radiotherapy
Rituximab
Palliative treatment

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents