NCT01164696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

1.8 years

First QC Date

July 16, 2010

Last Update Submit

August 23, 2010

Conditions

Lymphoma, FollicularNon-Hodgkin Lymphoma

Keywords

Quality of Life, Health Care Costs

Outcome Measures

Primary Outcomes (1)

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

    one year after inclusion

Secondary Outcomes (2)

  • 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

Study Arms (1)

Group 1

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

Interventions

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

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with relapsed or refractory FL who have been treated with 90Y-Zevalin in Belgium within the first 24 months after ethics approval

You may qualify if:

  • 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

You may not qualify if:

  • Patient is unwilling or unable to give informed consent
  • Patient is participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Belgium

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

BE(1)