Non-Hodgkin's Lymphoma (NHL)
Conditions
Keywords
Zevalin, CD20+, Non-Hodgkin's lymphoma, Mantle cell lymphoma
Brief 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.
Interventions
DRUG[111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Patients who have received In-111 Zevalin.
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Japan
Outcome results
None listed