NCT01479387

Brief Summary

This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin. When the imaging shows no altered distribution, Y-90 Zevalin is injected to the patient for the actual treatment. The objective of this study is to assess appropriateness and necessity of revision of the standardized criteria for image interpretation of In-111 Zevalin by comparing assessment by the investigator and the members of the committee for image interpretation of In-111 Zevalin. A total 40 patients will be recruited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

First QC Date

August 11, 2011

Last Update Submit

November 22, 2011

Conditions

Non-Hodgkin's Lymphoma (NHL)

Keywords

ZevalinCD20+Non-Hodgkin's lymphomaMantle cell lymphoma

Outcome Measures

Primary Outcomes (2)

  • Assessment of abnormal distribution of In-111 Zevalin by the investigator [Two scales; Yes or No]

    At 48-72 hours after In-111 Zevalin injection

  • Assessment of abnormal distribution of In-111 Zevalin by the central committee [Two scales; Yes or No]

    At 48-72 hours after In-111 Zevalin injection

Study Arms (1)

Group 1

Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Interventions

[111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)DRUG

Patients who have received In-111 Zevalin.

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population of this study is 40 patients who received In-111 Zevalin to access biodistribution of Zevalin.

You may qualify if:

  • Patients who received In-111 Zevalin to verify that expected biodistribution is present.

You may not qualify if:

  • Patients who are contraindicated based on the product label.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Mantle-Cell

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2011

First Posted

November 24, 2011

Study Start

August 1, 2008

Study Completion

February 1, 2011

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

JP(1)