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Economic Analysis of Alliance A041202 CLL Study

Active, not recruiting
Conditions
Chronic Lymphocytic Leukemia
Registration Number
NCT02414022
Lead Sponsor
Canadian Cancer Trials Group
Brief Summary

The prospective cost-effectiveness (cost-utility) analysis from the perspective of the Canadian public healthcare system was completed in 2021. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tarrifs applied to calculate quality-adjusted life-years (QALYs). Costs were applied to resource utilization data (expressed in 20196 US dollars). We examined costs and outcomes (QALYs) associated with ibrutinib with rituximab (IR) and BR therapy.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
55
Inclusion Criteria
  • Patient must be eligible for the core CLC.2/A041202 protocol.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Patient must be able (i.e. sufficiently fluent), and willing to complete the health utilities questionnaire in English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the core protocol. However, ability but unwillingness to complete the questionnaires will make the patient ineligible for the core protocol.
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Measure cost-utility ratio5 years

, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab.

Secondary Outcome Measures
NameTimeMethod
Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL5 years
Measure the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-rituximab compared to ibrutinib alone in elderly patients with CLL5 years
Measure the incremental cost-effectiveness, as measured in cost per life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL5 years
Measure the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-alone compared to bendamustine-rituximab in elderly patients with CLL5 years

Trial Locations

Locations (15)

Tom Baker Cancer Centre

🇨🇦

Calgary, Alberta, Canada

The Moncton Hospital

🇨🇦

Moncton, New Brunswick, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

🇨🇦

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

🇨🇦

Kingston, Ontario, Canada

London Regional Cancer Program

🇨🇦

London, Ontario, Canada

Stronach Regional Health Centre at Southlake

🇨🇦

Newmarket, Ontario, Canada

Ottawa Hospital Research Institute

🇨🇦

Ottawa, Ontario, Canada

Health Sciences North

🇨🇦

Sudbury, Ontario, Canada

Humber River Hospital

🇨🇦

Toronto, Ontario, Canada

Odette Cancer Centre Sunnybrook Health Sciences Centre

🇨🇦

Toronto, Ontario, Canada

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Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
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