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NCT00834951 Clinical Trial

Adjuvant Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma

Non Hodgkin's Lymphoma Clinical Trial

Official title:
A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00834951
Other study ID # LTBI-NHL-01
Secondary ID
Status Completed
Phase Phase 2
First received February 2, 2009
Last updated February 2, 2009
Start date January 2003
Est. completion date December 2008

Study information
Verified date February 2009
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count.

Exclusion Criteria:

- Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Radiation:
• Low dose total body irradiation
Low dose total body irradiation is given 3 weeks after the end of chemo-immunetherapy in the form of 4 daily fractions 0.2 Gy per fraction to be repeated after 2 weeks of rest

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Rigshospitalet, Denmark
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