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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164696
• Other study ID #: 13455
• Secondary ID: ZV0710BE
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: August 23, 2010
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: August 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Drug:
• [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Zevalin was administered according to the directives in the approved package leaflet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment		one year after inclusion	No
Secondary	the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)		baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline	No
Secondary	the clinical outcomes (survival status, response status), TTNT (time to next treatment)		1 year	No

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