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NCT Number: NCT01164696

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

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.

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Key information

Conditions

Lymphoma, Follicular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Zevalin was administered according to the directives in the approved package leaflet.

Primary outcomes

  1. 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

  1. the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM)

    Time frame: baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline

  2. the clinical outcomes (survival status, response status), TTNT (time to next treatment)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 19, 2010
Registry last updated
Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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