Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:

An Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Companion Analysis to CCTG CLC.3/SWOG 1925 Randomized Phase III Clinical Trial

Utilization data will be collected from all patients entered on the trial at Canadian centres from the time of registration until death, removal from study, or completion of 10 years of follow-up.

Protocol-specified health care utilization will be collected within trial case report forms, and will include study visits, radiographic assessments, laboratory investigations, and treatment administration.

Resource utilization data collection will be supplemented by a self-administered resource utilization form (Stanford SMRC) to document non-protocol specified utilization. This will include hospitalizations (including days in hospital), emergency room visits, and non-protocol specified ambulatory visits.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Intervention / Treatment: Other: EQ-5D-5L Instrument; Other: Work Productivity and Daily Activity Impairment (WPAI) survey; Other: Resource Utilization Form (SMRC)

• Study Type: Observational
• Enrollment (Estimated): 247

Contacts and Locations

• Study Contact: Name: Annette Hay; Phone Number: 613-533-6430; Email: ahay@ctg.queensu.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • BCCA - Vancouver
      • Contact: Alina Gerrie; Phone Number: 604 877-6000
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Recruiting
      • CancerCare Manitoba
      • Contact: Versha Banerji; Phone Number: 204 787-4904
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Recruiting
      • Regional Health Authority B, Zone 2
      • Contact: Alfonso Rivera Duarte; Phone Number: 506 648-7109
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Recruiting
      • QEII Health Sciences Centre
      • Contact: Katherine Sue Robinson; Phone Number: 902 473-2394
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Not yet recruiting
      • Lakeridge Health Oshawa
      • Contact: Lakshman Vasanthamohan; Phone Number: 32822 905 576-8711
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Ottawa Hospital Research Institute
      • Contact: David A. MacDonald
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • The Jewish General Hospital
      • Contact: Tanya Skamene; Phone Number: 514 340-8222
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Recruiting
      • Allan Blair Cancer Centre
      • Contact: Abdulhakim Eswedi; Phone Number: 306 766-2691

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All Canadian patients who are eligible for the core protocol CLC3/S1925 will be mandated to participate in the companion study CLC.3E.

This study is designed to include women and minorities as appropriate, but is not designed to measure differences in intervention effects.

Description

Inclusion Criteria:

• Patient must be eligible for the core CLC3/S1925 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 is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine incremental cost-utility ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL (enrolled in the randomized component of the SWOG S1925/CLC3 study).	Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. The denominator of the ratio will be expressed in quality-adjusted life years gained.	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL . Effectiveness will be expressed in life years gained	10 years
To determine the incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL. Effectiveness will be expressed in years prior to second progression gained.	10 years
To determine the direct medical costs associated with the care of Canadian high-risk CLL patients randomized to an early treatment approach compared to a deferred approach.	10 years
To compare the change in health preference (utility) over time for individuals with high-risk CLL randomized to an early approach vs. deferred treatment approach	10 years
To compare the lost productivity for Canadian individuals with high-risk CLL randomized to an early treatment approach compared to a deferred approach	10 years

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Study Chair: Matthew Cheung, Odette Cancer Centre, Sunnybrook Helath Sciences Centre, Toronto, Ontario, Canada

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 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; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: CLC3E

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