Zevalin Post-marketing Surveillance in Japan
Conditions
Non-Hodgkin's Lymphoma (NHL)
Conditions: official terms
Lymphoma, Non-Hodgkin
Conditions: Keywords
Zevalin, CD20+, Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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
Location
Many Locations, Japan
Status: Recruiting
Start Date
September 2008
Completion Date
January 2018
Sponsors
Bayer
Source
Bayer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page