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

NCT ID: NCT01479387

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma (NHL)

Keywords

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Zevalin CD20+ Non-Hodgkin's lymphoma Mantle cell lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Intervention Type DRUG

Patients who have received In-111 Zevalin.

Interventions

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

Patients who have received In-111 Zevalin.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Yakuhin Co.LTD.

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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15043

Identifier Type: -

Identifier Source: org_study_id