check_circleStudy Completed

Non-Hodgkin's Lymphoma (NHL)

Bayer Identifier:

15043

ClinicalTrials.gov Identifier:

NCT01479387

EudraCT Number:

Not Available

EU CT Number:

Not Available
Zevalin post-marketing surveillance for adequateness of image interpretation criteria in Japan

Trial 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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who received In-111 Zevalin to verify that expected biodistribution is present.
  • - Patients who are contraindicated based on the product label.

Trial summary

Enrollment Goal
72
Trial Dates
August 2008 - February 2011
Phase
N/A
Could I Receive a placebo
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]
    date_rangeTime Frame:
    At 48-72 hours after In-111 Zevalin injection
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    Safety Issue:
    No
  • Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]
    date_rangeTime Frame:
    At 48-72 hours after In-111 Zevalin injection
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special drug use investigation of Zevalin
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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