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Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance
This study has been completed.
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582166
First received: December 19, 2007
Last updated: June 2, 2014
Last verified: June 2014
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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: 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:
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| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00582166
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, Madison |
| ClinicalTrials.gov Identifier: | NCT00582166 History of Changes |
| Other Study ID Numbers: |
HO04405 |
| Study First Received: | December 19, 2007 |
| Last Updated: | June 2, 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 |
ClinicalTrials.gov processed this record on August 16, 2017