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 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.
Interventions
Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.
Sponsors
Bayer
Spectrum Pharmaceuticals, Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Change in neutrophil from baseline | 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 |
Countries
Japan
Outcome results
None listed