Zevalin Post-marketing Surveillance in Japan

Non-Hodgkin's Lymphoma (NHL) Clinical Trial

— ZEVALIN-DUI  

Official title:

Drug Use Investigation of Zevalin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448928
• Other study ID #: 15042
• Status: Completed
• Start date: September 2008
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma (NHL)

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc	Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions in subjects who received Zevalin		After In-111 Zevalin administration, up to 13 weeks
Primary	Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin		After In-111 Zevalin administration, up to 8 years
Secondary	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
Secondary	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
Secondary	Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response		After In-111 Zevalin administration, up to 8 years
Secondary	Change in hemoglobin from baseline		After In-111 Zevalin administration, up to 13 weeks
Secondary	Change in neutrophil from baseline		After In-111 Zevalin administration, up to 13 weeks
Secondary	Change in platelet from baseline		After In-111 Zevalin administration, up to 13 weeks
Secondary	Change in leukocyte from baseline		After In-111 Zevalin administration, up to 13 weeks