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
Completed
- Conditions
- Lymphoma, FollicularNon-Hodgkin Lymphoma
- Interventions
- Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Registration Number
- NCT01164696
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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Exclusion Criteria
- Patient is unwilling or unable to give informed consent
- Patient is participating in another clinical trial
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) -
- Primary Outcome Measures
Name Time Method The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment one year after inclusion
- Secondary Outcome Measures
Name Time Method 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 the clinical outcomes (survival status, response status), TTNT (time to next treatment) 1 year