Zevalin Post-marketing Surveillance in Japan

N/ACompletedNCT01448928

Spectrum Pharmaceuticals, Inc400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Non-Hodgkin's Lymphoma (NHL)

Interventions

[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)DRUG

Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Incidence of adverse drug reactions in subjects who received Zevalin

Time frame: After In-111 Zevalin administration, up to 13 weeks

Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin

Time frame: After In-111 Zevalin administration, up to 8 years

Secondary Outcomes

Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]

Time frame: 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

Time frame: After In-111 Zevalin administration, up to 13 weeks

Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response

Time frame: After In-111 Zevalin administration, up to 8 years

Change in hemoglobin from baseline

Time frame: After In-111 Zevalin administration, up to 13 weeks

Change in neutrophil from baseline

Time frame: After In-111 Zevalin administration, up to 13 weeks

Change in platelet from baseline

Time frame: After In-111 Zevalin administration, up to 13 weeks

Change in leukocyte from baseline

Time frame: After In-111 Zevalin administration, up to 13 weeks

Data from ClinicalTrials.gov

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NCT01448928 - Zevalin Post-marketing Surveillance in Japan | Crick | Crick