Chronic Lymphocytic LeukemiaNCT05371808
Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:
An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Canadian Cancer Trials Group at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- EQ-5D-5L Instrument, Work Productivity and Daily Activity Impairment (WPAI) survey and Resource Utilization Form (SMRC)
- How many people
- 247 participants
- Where
- 6 sitesCanada
- Study dates
- 27 Jan 2023to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 5 recruiting
- Recruiting
The Jewish General Hospital
Montreal, Quebec, H3T 1E2
Tanya Skamene, 514 340-8222
- Not yet recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Lakshman Vasanthamohan, 905 576-8711 ext. 32822
- Withdrawn
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
- Recruiting
Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2
Alfonso Rivera Duarte, 506 648-7109
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Alina Gerrie, 604 877-6000
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Versha Banerji, 204 787-4904
About this study
Official title: 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.
- Being tested
- EQ-5D-5L Instrument, Work Productivity and Daily Activity Impairment (WPAI) survey, Resource Utilization Form (SMRC)
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ-5D-5L InstrumentOther
This instrument is a measure of health status for use in evaluating health and healthcare.
Work Productivity and Daily Activity Impairment (WPAI) surveyOther
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)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start27 Jan 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Matthew Cheung, Study chair, Odette Cancer Centre, Sunnybrook Helath Sciences Centre, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371808
- Sponsor's protocol ID
- CLC3E
- Status last verified
- May 2026
- First submitted
- 9 May 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05371808
- Acronym / sponsor ID
- CLC3E
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ-5D-5L InstrumentThis instrument is a measure of health status for use in evaluating health and healthcare. | Other | – |
| Work Productivity and Daily Activity Impairment (WPAI) surveyThe 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) | Other | – |
| 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. | Other | – |
Primary outcome
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
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.
5 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Cheung study chair
Odette Cancer Centre, Sunnybrook Helath Sciences Centre, Toronto, Ontario, Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Canadian Cancer Trials Group at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Hay (613-533-6430, ahay@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.