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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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: Cancer Lymphoma
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 ]

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

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, Madison
ClinicalTrials.gov Identifier: NCT00582166     History of Changes
Other Study ID Numbers: HO04405
Study First Received: December 19, 2007
Last Updated: April 17, 2013
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:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013