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
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
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
NCT ID
NCT00147953
First Posted
September 2, 2005
Last Updated
January 26, 2010
Sponsor
University of Cologne
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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