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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479387
First Posted: November 24, 2011
Last Update Posted: November 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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:


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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479387


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

Additional Information:
Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01479387     History of Changes
Other Study ID Numbers: 15043
First Submitted: August 11, 2011
First Posted: November 24, 2011
Last Update Posted: November 24, 2011
Last Verified: November 2011

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

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