Zevalin Post-marketing Surveillance in Japan
Completed
- Conditions
- Non-Hodgkin's Lymphoma (NHL)
- Interventions
- Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Registration Number
- NCT01448928
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Patients who received Zevalin for relapsed or refractory:
- CD20+
- low grade B-cell non-Hodgkin's lymphoma
- Mantle cell lymphoma
Exclusion Criteria
- Patients who are contraindicated based on the product label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) -
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin After In-111 Zevalin administration, up to 8 years Incidence of adverse drug reactions in subjects who received Zevalin After In-111 Zevalin administration, up to 13 weeks
- Secondary Outcome Measures
Name Time Method 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 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 [progression free survival] by investigator-determined overall best response After In-111 Zevalin administration, up to 8 years Change in neutrophil from baseline After In-111 Zevalin administration, up to 13 weeks Change in hemoglobin 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