drugset
drugset / Trial / NCT01510184

Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy

NCT01510184 ↗

Phase 3 Terminated 79 enrolled Spectrum Pharmaceuticals, Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

Timeline

Start
2012-04-19
Primary completion
2014-10-23
Completion
2014-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject 90Y-ibritumomab tiuxetan Other / unclassified 11.1 mbq/kg Intravenous
Subject 90Y-ibritumomab tiuxetan Other / unclassified 14.8 mbq/kg Intravenous
Subject ibritumomab tiuxetan Monoclonal antibody — Intravenous
Background In-111-Zevalin Unknown 185 mbq Intravenous
Background Rituximab Monoclonal antibody 250 mg/m2 Intravenous

Indications

diffuse large B-cell lymphoma follicular lymphoma