Zevalin Post-marketing Surveillance for Adequateness of I... | NCT01479387

Studies
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan

NCT01479387

Sponsor

Bayer

Status

Completed

Last Update Posted

Nov 24, 2011Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Non-Hodgkin's Lymphoma (NHL)

Interventions

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

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Not provided

Completion Date

Feb 2011Actual

First Submitted Date

Aug 11, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2011

Last Update Posted Date

Nov 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)	Drug	Patients who have received In-111 Zevalin.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who are contraindicated based on the product label.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D020522	Lymphoma, Mantle-Cell

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C422802	ibritumomab tiuxetan

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided