Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582166
First received: December 19, 2007
Last updated: June 2, 2014
Last verified: June 2014

December 19, 2007
June 2, 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582166
HO04405
Yes
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