Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Sponsor Canadian Cancer Trials Group
Start date April 2015
End date April 2020
Trial size 51 participants
Trial identifier NCT02414022, CLC2E

Summary

The planned analysis is a prospective cost-effectiveness (cost-utility) analysis from the perspective of the Canadian public healthcare system, examining the costs and outcomes (quality-adjusted life years gained) of ibrutinib-based therapy compared to a standard therapy (bendamutine-rituximab). Collection and management of the data required for the economic analyses (including resource utilization and outcomes) will be fully integrated into the clinical data. Health state utilities will be derived directly from the study population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Measure cost-utility ratio
time frame: 5 years

Secondary Outcomes

Measure
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
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
Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL
time frame: 5 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 CLL
time frame: 5 years
Measure incremental cost-utility comparing bendamustine-rituximab, ibrutinib, and ibrutinib-rituximab according to biologic subgroupsd
time frame: 5 years
Present disaggregated direct medical costs associated with treatment with ibrutinib-rituximab, ibrutinib alone, and bendamustine-rituximab
time frame: 5 years
To describe the resource utilization (hospitalizations, outpatient ambulatory visits including hematology and ophthalmology assessments, chemotherapy suite visits, transfusions, concomitant medications) associated with the three treatment arms
time frame: 5 years
To determine the change in utility over time comparing the three treatment arms
time frame: 5 years

Eligibility Criteria

Male or female participants at least 65 years old.

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:

Additional Information

Official title A Prospective Economic Analysis NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (≥65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Canadian Cancer Trials Group.