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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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Rituximab
Total nodal irradiation
Sponsored by
University of Cologne
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL, Lymphoma, Radiotherapy, Rituximab, Palliative treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cologne

Outcomes

Primary Outcome Measures

Overall response rate (complete and partial response rate)

Secondary Outcome Measures

Toxicity
Time to progression
Response duration
Quality-of-Life

Full Information

First Posted
September 2, 2005
Last Updated
January 26, 2010
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT00147953
Brief Title
Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
Official Title
A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cologne

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
NHL, Lymphoma, Radiotherapy, Rituximab, Palliative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Procedure
Intervention Name(s)
Total nodal irradiation
Primary Outcome Measure Information:
Title
Overall response rate (complete and partial response rate)
Secondary Outcome Measure Information:
Title
Toxicity
Title
Time to progression
Title
Response duration
Title
Quality-of-Life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R.-P. Mueller
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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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