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Active, not recruiting

NCT Number: NCT02414022

Economic Analysis of Alliance A041202 CLL Study

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Measure cost-utility ratio

    Time frame: 5 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 outcomes

  1. 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 CLL

    Time frame: 5 years

  2. 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 CLL

    Time frame: 5 years

  3. Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL

    Time frame: 5 years

  4. 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 CLL

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Canadian Cancer Trials Group

Network

Registry information

Official study title

Prospective Economic Analysis: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab Versus Ibrutinib + Rituximab vs Ibrutinib Alone in Untreated Older Patients (≥65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Important dates

Study start
2015
Primary completion
2019
Study completion
2026
First posted
Apr 10, 2015
Registry last updated
Jun 30, 2026

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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