NCT01448928

Zevalin Post-marketing Surveillance in Japan

Drug Use Investigation of Zevalin

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.

Conditions

• Non-Hodgkin's Lymphoma (NHL)

Interventions

Type	Name	Description
DRUG	[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)	Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.

Timeline

• Start date: 2008-09-01
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2011-10-07
• Last updated: 2021-10-01

Locations

1 site across 1 country: Japan