Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan (ZEVALIN-SDUI)

Bayer

Status: Completed

Conditions: Non-Hodgkin's Lymphoma (NHL)

Treatments: Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Study type: Observational

Funder types: Industry

Identifiers

NCT01479387

15043

Details and patient eligibility

About

This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received In-111 Zevalin to verify that expected biodistribution is present.

Exclusion criteria

• Patients who are contraindicated based on the product label.

Trial design

72 participants in 1 patient group

Group 1

Treatment:

Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)