University of Iowa Hospitals and Clinics

Clinical Trial Details

Short Title
A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (ibritumomab tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy
Official Title

A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (ibritumomab tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

Description

Participants in this study have diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma and must be at least 60 years old. Participants must also have received standard chemotherapy and their PET scans must show they had a complete response after chemotherapy.

This study is being done to see how well the study drug called Zevalin (ibritumomab tiuxetan) works and if it is safe to give. The study will compare the effects of the study drug with observation (no further therapy). Observation is standard care for cancer that is in complete remission. About 490 subjects with DLBCL from 80 sites worldwide will take part in this study.

Start Date
April 30, 2013
End Date
September 9, 2014
Gender Preference
None
Age Group
60 - 99 years
Principal Investigator
Brian Link, MD
Contact Info

Susan Gillen, 319-467-5827

Department
Department or Field of Study
Keywords
cancer ; DLBCL ; follicular lymphoma ; IRB#201211503 ; link ; phase 3 ; phase III ; Zevalin ;

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