Clinical trial · Observational
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
A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin
NCT01164696CI-TRIAL-00003838completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Primary outcomes (1)
- measure
- The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
- timeFrame
- one year after inclusion
Secondary outcomes (2)
- measure
- 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
- measure
- the clinical outcomes (survival status, response status), TTNT (time to next treatment)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.