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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Ibritumomab tiuxetan

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	September 2004
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Zevalin with Rituximab maintenance: Experimental	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

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

No publications provided

Responsible Party:	University Of Wisconsin ( Brad Kahl, MD )
Study ID Numbers:	HO04405
Study First Received:	December 19, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00582166 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

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

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions

Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 20, 2009