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Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00582166
First Posted: December 28, 2007
Last Update Posted: June 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
December 19, 2007
December 28, 2007
June 4, 2014
September 2004
March 2013   (Final data collection date for primary outcome measure)
CT scans [ Time Frame: before and after treatment. every 3 mo after ]
Same as current
Complete list of historical versions of study NCT00582166 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance
Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma
Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
The objective of this study is to estimate the median progression -free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: Zevalin (Ibritumomab Tiuxetan )+ Rituximab
Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
Experimental: Zevalin with Rituximab maintenance
Intervention: Drug: Zevalin (Ibritumomab Tiuxetan )+ Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3
  • Meeting FLIPI criteria for intermediate or high risk.
  • No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;
  • Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.

Exclusion Criteria:

  • May not be pregnant or breastfeeding, have documented CNS disease, G-CSF or GM-CSF within 2 weeks prior
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00582166
HO04405
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Brad S Kahl, MD University of Wisconsin, Madison
University of Wisconsin, Madison
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP