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: | 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:
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 (Adult, Senior) |
| 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
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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.
For general information, see Learn About Clinical Studies.
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 |
| 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 Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 23, 2016