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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Rigshospitalet, Denmark
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00834951
First received: February 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Non Hodgkin's Lymphoma
Radiation: Low dose total body irradiation
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Enrollment: 40
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Francesco d'Amore/Consultant, Haematology Department, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00834951     History of Changes
Other Study ID Numbers: LTBI-NHL-01
Study First Received: February 2, 2009
Last Updated: February 2, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Diffuse large B-cell lymphoma
Elderly patients
Low dose total body irradiation
RCHOP14

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014