Chronic Lymphocytic LeukemiaNCT02414022
Economic Analysis of Alliance A041202 CLL Study
An observational study of Chronic Lymphocytic Leukemia, run by Canadian Cancer Trials Group at 15 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 55 participants
- Where
- 15 sitesCanada
- Study dates
- 15 Apr 2015to 31 Dec 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Untreated Older Patients (≥65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Tom Baker Cancer Centre
Calgary, Alberta
Health Sciences North
Greater Sudbury, Ontario
CSSS Champlain-Charles LeMoyne
Greenfield Park, Quebec
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario
Kingston Health Sciences Centre
Kingston, Ontario, K7L3N6
London Regional Cancer Program
London, Ontario
The Moncton Hospital
Moncton, New Brunswick
CHUM-CEntre Hospitalier de l'Universite de Montreal
Montreal, Quebec
The Jewish General Hospital
Montreal, Quebec
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9
Ottawa Hospital Research Institute
Ottawa, Ontario
Allan Blair Cancer Centre
Regina, Saskatchewan
Humber River Hospital
Toronto, Ontario
Odette Cancer Centre Sunnybrook Health Sciences Centre
Toronto, Ontario
University Health Network Princess Margaret Cancer Centre
Toronto, Ontario
About this 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)
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
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
Measured: 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
Measured: 5 years
Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start15 Apr 2015
- Primary completion5 Apr 2019
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Matthew Cheung, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414022
- Sponsor's protocol ID
- CLC2E
- Status last verified
- May 2026
- First submitted
- 7 Apr 2015
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34334330
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02414022
- Acronym / sponsor ID
- CLC2E
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2015 (estimated)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Untreated Older Patients (≥65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure cost-utility ratio
Time frame: 5 years
, 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.
4 secondary outcomes
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
Time frame: 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
Time frame: 5 years
Measure the extended dominance exerted by ibrutinib-rituximab or ibrutinib when compared to bendamustine-rituximab in elderly patients with CLL
Time frame: 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
Time frame: 5 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 30 Jun 2026.
- Results publication: PubMed 34334330Cheung 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.
- 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. This study is not recruiting at the moment.
Matthew Cheung study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON Canada
15 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, run by Canadian Cancer Trials Group at 15 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 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure cost-utility ratio (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414022, which also lists 1 linked publication.
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 30 Jun 2026.