Trial Condition(s):
Lymphoma, Follicular
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
Bayer Identifier:
13455
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A prospective observational study to evaluate quality of life and costs in a real life setting in patients treated with 90Y-Zevalin
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatmentTimeframe: one year after inclusion
Secondary Outcome
- the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)Timeframe: 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)Timeframe: 1 year
Additional Information
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