Recruiting

Early vs. Delayed Therapy

Sponsor:

Canadian Cancer Trials Group

Code:

NCT05371808

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EQ-5D-5L Instrument

Work Productivity and Daily Activity Impairment (WPAI) survey

Resource Utilization Form (SMRC)

Study Details

Brief summary:

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.

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT05371808

Start date

Jan 27, 2023

Status verified date

May, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

247 participants

Anticipated

Interventions and Outcome Measures

Interventions

EQ-5D-5L Instrument

This instrument is a measure of health status for use in evaluating health and healthcare.

Work Productivity and Daily Activity Impairment (WPAI) survey

The questionnaire includes three open-ended questions that determines: 1) hours absent from work due to health problems; 2) hours absent from work due to other reasons; and (3) hours actually worked over the past 30 days. Additional questions ask about the impact of health problems on work productivity and daily activities and are scored along a vertical visual analog scale. The WPAI provides estimates on absenteeism, presenteeism, global measures of lost productivity (absenteeism+presenteeism) and daily activity impairment (impaired ability to perform non-work activities including work around the house, child care, exercise, studying, and leisure activities)

Resource Utilization Form (SMRC)

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.

Primary outcome measure

  • 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). [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Annette Hay

613-533-6430ahay@ctg.queensu.ca

Locations

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Alina Gerrie

604 877-6000

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Versha Banerji

204 787-4904

Regional Health Authority B, Zone 2

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Contacts

Alfonso Rivera Duarte

506 648-7109

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Tanya Skamene

514 340-8222

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Jul 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-07-14.