Trial Information

Summary: A Phase III, Open-Label, Prospective, Two-Armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment with the Zevalin (Ibritumomab Tiuxetan) Study Regimen Versus Observation in Patients with Diffuse Large B-Cell Lymphoma Who Are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy. Iogen Iden, Inc. Protocol #307940/106-20

You have been asked to participate in this research study because you have diffuse large B-cell lymphoma (DLBCL) and your disease is in complete remission (no evidence of disease by standard clinical tests) following treatment with cyclophosphamide, vincristine, prednisone, doxorubicin plus rituximab (CHOP-R).  The purpose of this study is to look at the safety and effectiveness of treatment with Zevalin plus rituximab compared with observation alone (routine check ups only) when used in subjects with DLBCL who are in complete remission following treatment with CHOP-R.  The study also involves questionnaires to compare quality of life of persons receiving Zevalin plus rituximab to persons under observation only.  Participation in this study involves about 10 weeks for the screening period.  Active treatment and/or monitoring will last for about 13 weeks.  After this time, you will receive study follow up for up to four years.  After treatment, you will be in long-term follow-up until you are removed from the study or the study has completed.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: July 7, 2008 at 2:42:25 PM