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

Bayer0 sites30 target enrollmentAugust 2007

ConditionsLymphoma, Follicular Non-Hodgkin Lymphoma

Interventions[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Drugs[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Overview

Phase: Not Applicable
Intervention: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Conditions: Lymphoma, Follicular
Sponsor: Bayer
Enrollment: 30
Primary Endpoint: The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

May 2009

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Eligibility Criteria

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

Arms & Interventions

Group 1

Intervention: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Outcomes

Primary Outcomes

The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment

Time Frame: one year after inclusion

Secondary Outcomes

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)