Economic Analysis of Alliance A041202 CLL Study

Chronic Lymphocytic Leukemia Clinical Trial

Official 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02414022
• Other study ID #: CLC2E
• Status: Active, not recruiting
• Start date: April 15, 2015
• Est. completion date: January 30, 2025

Study information

• Verified date: April 2024
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: January 30, 2025
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	CSSS Champlain-Charles LeMoyne	Greenfield Park	Quebec
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	The Moncton Hospital	Moncton	New Brunswick
Canada	CHUM-CEntre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Jewish General Hospital	Montréal	Quebec
Canada	Stronach Regional Health Centre at Southlake	Newmarket	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Health Sciences North	Sudbury	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Canada	Odette Cancer Centre Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Cheung MC, Mittmann N, Owen C, Abdel-Samad N, Fraser GAM, Lam S, Crump M, Sperlich C, van der Jagt R, Prica A, Couban S, Woyach JA, Ruppert AS, Booth AM, Mandrekar SJ, McDonald G, Shepherd LE, Yen H, Chen BE, Hay AE. A Prospective Economic Analysis of Ear — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure cost-utility ratio	, 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.	5 years
Secondary	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		5 years
Secondary	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		5 years
Secondary	Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL		5 years
Secondary	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		5 years