Zevalin Post-marketing Surveillance in Japan (ZEVALIN-DUI)

September 30, 2021 updated by: Spectrum Pharmaceuticals, Inc

Drug Use Investigation of Zevalin

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions in subjects who received Zevalin
Time Frame: After In-111 Zevalin administration, up to 13 weeks
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
After In-111 Zevalin administration, up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
After In-111 Zevalin administration, up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Hodgkin's Lymphoma (NHL)

Clinical Trials on [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe