check_circleStudy Completed

Lymphoma, Follicular, Non-Hodgkin Lymphoma

Bayer Identifier:

13455

ClinicalTrials.gov Identifier:

NCT01164696

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - Patient is unwilling or unable to give informed consent
    - Patient is participating in another clinical trial

Trial summary

Enrollment Goal
30
Trial Dates
August 2007 - May 2009
Phase
N/A
Could I Receive a placebo
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Belgium

Primary Outcome

  • The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment
    date_rangeTime Frame:
    one year after inclusion
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    Safety Issue:
    No

Secondary Outcome

  • the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)
    date_rangeTime Frame:
    baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline
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    Safety Issue:
    No
  • the clinical outcomes (survival status, response status), TTNT (time to next treatment)
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    No

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
N/A

Additional Information

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