Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance - Full Text View

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 II

MedlinePlus related topics:

Cancer Lymphoma

Drug Information available for:

Rituximab Ibritumomab tiuxetan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	September 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 ( Brad Kahl, MD )
Study ID Numbers:	HO04405
First Received:	December 19, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00582166
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Patients with High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma

Study placed in the following topic categories:

Antibodies, Monoclonal

Lymphatic Diseases

Antibodies

Immunoproliferative Disorders

Rituximab

Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00582166