Zevalin Post-marketing Surveillance in Japan (ZEVALIN-DUI)

Spectrum Pharmaceuticals

Status: Completed

Conditions: Non-Hodgkin's Lymphoma (NHL)

Treatments: Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Study type: Observational

Funder types: Industry

Identifiers

NCT01448928

15042

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who received Zevalin for relapsed or refractory:

• CD20+
• low grade B-cell non-Hodgkin's lymphoma
• Mantle cell lymphoma

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

400 participants in 1 patient group

Group 1

Treatment:

Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)