Clinical trial NCT02414022: Economic Analysis of Alliance A041202 CLL Study
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
First posted: 2015-04-10
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Untreated Older Patients (≥65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measure cost-utility ratio
timeFrame: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL
timeFrame: 5 years
measure: 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
timeFrame: 5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre at Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional Health Centre at Southlake
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Cancer Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: CSSS Champlain-Charles LeMoyne
state: Quebec
city: Montreal
country: Canada
facility: CHUM-CEntre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montréal
country: Canada
facility: The Jewish General Hospital
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON Canada
name: Matthew Cheung
role: STUDY_CHAIR
References:
citation: 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 Early Outcome Data From the Alliance A041202/ CCTG CLC.2 Randomized Phase III Trial Of Bendamustine-Rituximab Compared With Ibrutinib-Based Regimens in Untreated Older Patients With Chronic Lymphocytic Leukemia. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):766-774. doi: 10.1016/j.clml.2021.06.011. Epub 2021 Jul 3.