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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B-cell Lymphoma
• Follicle Center Lymphoma

Interventions

Type	Name	Description
DRUG	Zevalin	Zevalin administered intravenous infusion.
DRUG	Y-90-Zevalin	Y-90-Zevalin administered by intravenous infusion.
DRUG	Rituximab	Rituximab administered by intravenous infusion.
DRUG	In-111 Zevalin	In-111-Zevalin administered by intravenously.

Timeline

• Start date: 2012-04-19
• Primary completion: 2014-10-23
• Completion: 2014-10-23
• First posted: 2012-01-13
• Last updated: 2021-12-16
• Results posted: 2021-12-16

Locations

93 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, France, Ireland, Israel, Italy, Netherlands, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study