Lymphoma, Follicular, Non-Hodgkin Lymphoma
Conditions
Keywords
Quality of Life, Health Care Costs
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.
Interventions
Zevalin was administered according to the directives in the approved package leaflet.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment | one year after inclusion |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed