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: April 17, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

April 17, 2013

Start Date ^ICMJE

September 2004

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CT scans [ Time Frame: before and after treatment. every 3 mo after ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00582166 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance

Official Title ^ICMJE

Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma

Brief Summary

Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Zevalin with Rituximab maintenance

Intervention: Drug: Zevalin (Ibritumomab Tiuxetan )+ Rituximab

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00582166

Other Study ID Numbers ^ICMJE

HO04405

Has Data Monitoring Committee

Yes

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Brad S Kahl, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

April 2013

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

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