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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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01164696
First received: July 16, 2010
Last updated: August 23, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Lymphoma, Follicular
Non-Hodgkin Lymphoma
 Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment [ Time Frame: one year after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • the clinical outcomes (survival status, response status), TTNT (time to next treatment) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Zevalin was administered according to the directives in the approved package leaflet.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164696

Locations
Belgium
Many Locations, Belgium
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01164696     History of Changes
Other Study ID Numbers: 13455, ZV0710BE
Study First Received: July 16, 2010
Last Updated: August 23, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Bayer:
Quality of Life, Health Care Costs

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013