ZEVALIN-DUI: Zevalin Post-marketing Surveillance in Japan
Study Details
Study Description
Brief Summary
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1
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Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse drug reactions in subjects who received Zevalin [After In-111 Zevalin administration, up to 13 weeks]
- Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin [After In-111 Zevalin administration, up to 8 years]
Secondary Outcome Measures
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging] [After In-111 Zevalin administration, up to 13 weeks]
- Effectiveness evaluation assessment [complete remission rate, complete remission uncertain rate, partial remission rate, stable disease rate, progression disease rate] by investigator-determined overall best response [After In-111 Zevalin administration, up to 13 weeks]
- Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response [After In-111 Zevalin administration, up to 8 years]
- Change in hemoglobin from baseline [After In-111 Zevalin administration, up to 13 weeks]
- Change in neutrophil from baseline [After In-111 Zevalin administration, up to 13 weeks]
- Change in platelet from baseline [After In-111 Zevalin administration, up to 13 weeks]
- Change in leukocyte from baseline [After In-111 Zevalin administration, up to 13 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients who received Zevalin for relapsed or refractory:
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CD20+
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low grade B-cell non-Hodgkin's lymphoma
-
Mantle cell lymphoma
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Japan |
Sponsors and Collaborators
- Spectrum Pharmaceuticals, Inc
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15042