Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma
18 Years
N/A
Both
Non-Hodgkin's Lymphoma
Trial Information
Ibritumomab Tiuxetan Plus Rituximab as Initial Therapy for Patients With High Tumor Burden, Indolent Histology Non-Hodgkin's Lymphoma
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
CT scans
Outcome Time Frame:
before and after treatment. every 3 mo after
Safety Issue:
No
Principal Investigator
Brad S Kahl, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Institutional Review Board
Study ID:
HO04405
NCT ID:
NCT00582166
Start Date:
September 2004
Completion Date:
March 2013
Related Keywords:
- Non-Hodgkin's Lymphoma
- Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
