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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01479387
First received: August 11, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Non-Hodgkin's Lymphoma (NHL)
 Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of Zevalin

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No] [ Time Frame: At 48-72 hours after In-111 Zevalin injection ] [ Designated as safety issue: No ]
  • Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No] [ Time Frame: At 48-72 hours after In-111 Zevalin injection ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: August 2008
Study Completion Date: February 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Patients who have received In-111 Zevalin.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population of this study is 40 patients who received In-111 Zevalin to access biodistribution of Zevalin.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479387

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01479387     History of Changes
Other Study ID Numbers: 15043
Study First Received: August 11, 2011
Last Updated: November 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Zevalin
CD20+
Non-Hodgkin's lymphoma
Mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013