Economic Analysis of Alliance A041202 CLL Study

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Lymphocytic Leukemia

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Tom Baker Cancer Centre
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • The Moncton Hospital
  • Ontario
    • Greater Sudbury, Ontario, Canada
      • Health Sciences North
    • Hamilton, Ontario, Canada
      • Juravinski Cancer Centre at Hamilton Health Sciences
    • Kingston, Ontario, Canada, K7L3N6
      • Kingston Health Sciences Centre
    • London, Ontario, Canada
      • London Regional Cancer Program
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Stronach Regional Health Centre at Southlake
    • Ottawa, Ontario, Canada
      • Ottawa Hospital Research Institute
    • Toronto, 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
  • Quebec
    • Greenfield Park, Quebec, Canada
      • CSSS Champlain-Charles LeMoyne
    • Montreal, Quebec, Canada
      • CHUM-Centre Hospitalier de l'Universite de Montreal
    • Montreal, Quebec, Canada
      • The Jewish General Hospital
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Allan Blair Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Untreated Older Patients (≥65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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
Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL	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	5 years

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Investigators: Study Chair: Matthew Cheung, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON Canada

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2015
• Primary Completion (Actual): April 5, 2019
• Study Completion (Estimated): June 7, 2026

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimated): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: CLC2E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No