Clinical trial NCT01448928: Zevalin Post-marketing Surveillance in Japan
Official title: Drug Use Investigation of Zevalin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Hodgkin's Lymphoma (NHL)
Keywords: Zevalin
CD20+
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2011-10-07
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 400cases: This study is all case investigation of which the enrollment period is five years, and all patients who received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma will be recruited.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse drug reactions in subjects who received Zevalin
timeFrame: After In-111 Zevalin administration, up to 13 weeks
measure: Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
timeFrame: After In-111 Zevalin administration, up to 8 years
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]
timeFrame: After In-111 Zevalin administration, up to 13 weeks
measure: 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
timeFrame: After In-111 Zevalin administration, up to 13 weeks
measure: Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response
timeFrame: After In-111 Zevalin administration, up to 8 years
measure: Change in hemoglobin from baseline
timeFrame: After In-111 Zevalin administration, up to 13 weeks
measure: Change in neutrophil from baseline
timeFrame: After In-111 Zevalin administration, up to 13 weeks
measure: Change in platelet from baseline
timeFrame: After In-111 Zevalin administration, up to 13 weeks
measure: Change in leukocyte from baseline
timeFrame: After In-111 Zevalin administration, up to 13 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References: