A Prospective Observational Study to Evaluate the Quality of Life and the Costs in a Real Life Setting in Patients Who Are Treated With 90Y-Zevalin

August 23, 2010 updated by: Bayer

A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin

The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with relapsed or refractory FL who have been treated with 90Y-Zevalin in Belgium within the first 24 months after ethics approval

Description

Inclusion Criteria:

  • Advanced cancer of the lymph nodes of follicular type at study inclusion
  • The patient has relapsed or has refractory disease, after previous treatment with rituximab
  • Treating physician has decided to treat the patient with a 90Y-Zevalin regimen
  • The patient is >= 18 years of age
  • Patient has given informed consent

Exclusion Criteria:

  • Patient is unwilling or unable to give informed consent
  • Patient is participating in another clinical trial

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)
Zevalin was administered according to the directives in the approved package leaflet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
Time Frame: one year after inclusion
one year after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)
Time Frame: baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline
baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline
the clinical outcomes (survival status, response status), TTNT (time to next treatment)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

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

August 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13455 (Other Identifier: City of Hope Medical Center)
  • ZV0710BE

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.

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