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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

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ClinicalTrials.gov Identifier: NCT01164696
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : August 24, 2010
Sponsor:
Information provided by:
Bayer

Brief Summary:
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 or disease Intervention/treatment
Lymphoma, Follicular Non-Hodgkin Lymphoma Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Study Type : Observational
Actual Enrollment : 30 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment [ Time Frame: one year after inclusion ]

Secondary Outcome Measures :
  1. 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 ]
  2. the clinical outcomes (survival status, response status), TTNT (time to next treatment) [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164696


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

Additional Information:
Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT01164696     History of Changes
Other Study ID Numbers: 13455
ZV0710BE
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010

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

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