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

Purpose

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

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Zevalin (Ibritumomab Tiuxetan )+ Rituximab	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Ibritumomab tiuxetan

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

CT scans [ Time Frame: before and after treatment. every 3 mo after ]


Enrollment:	18
Study Start Date:	September 2004
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zevalin with Rituximab maintenance	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

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582166

Locations


United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators


Principal Investigator:	Brad S Kahl, MD	University of Wisconsin, Madison

More Information


Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00582166 History of Changes
Other Study ID Numbers:	HO04405
First Submitted:	December 19, 2007
First Posted:	December 28, 2007
Last Update Posted:	June 4, 2014
Last Verified:	June 2014

Keywords provided by University of Wisconsin, Madison:


Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:


Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders	Immune System Diseases Rituximab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

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