Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan

Non-Hodgkin's Lymphoma (NHL) Clinical Trial

— ZEVALIN-SDUI  

Official title:

Special Drug Use Investigation of Zevalin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479387
• Other study ID #: 15043
• Status: Completed
• Phase: N/A
• First received: August 11, 2011
• Last updated: November 22, 2011
• Start date: August 2008
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma (NHL)

Intervention

Drug:
• [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Patients who have received In-111 Zevalin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]		At 48-72 hours after In-111 Zevalin injection	No
Primary	Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]		At 48-72 hours after In-111 Zevalin injection	No

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