Zevalin(Ibritumomab Tiuxetan)+ Rituximab Maintenance
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ClinicalTrials.gov Identifier: NCT00582166 |
Recruitment Status
:
Completed
First Posted
: December 28, 2007
Last Update Posted
: June 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Hodgkin's Lymphoma | Drug: Zevalin (Ibritumomab Tiuxetan )+ Rituximab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
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
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- CT scans [ Time Frame: before and after treatment. every 3 mo after ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582166
United States, Wisconsin | |
University Of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Brad S Kahl, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00582166 History of Changes |
Other Study ID Numbers: |
HO04405 |
First Posted: | December 28, 2007 Key Record Dates |
Last Update Posted: | June 4, 2014 |
Last Verified: | June 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 |