Comparing early and delayed therapy for high-risk patients with chronic lymphocytic leukemia.
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
This study is trying to see if starting treatment right away or waiting longer is better for high-risk patients with chronic lymphocytic leukemia and how it affects their healthcare costs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 247 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canadian Cancer Trials Group Research network |
| Locations | 8 sites (Vancouver, British Columbia and 7 other locations) |
| Trial ID | NCT05371808 on ClinicalTrials.gov |
What this trial studies
This study collects data on healthcare utilization from newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia and small lymphocytic lymphoma across various Canadian centers. Patients will be monitored from registration until death, removal from the study, or completion of a 10-year follow-up. The study will gather information on study visits, radiographic assessments, laboratory tests, and treatment administration, supplemented by a self-administered resource utilization form to capture additional healthcare interactions. The aim is to analyze the economic implications of early versus delayed therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who meet the eligibility criteria.
Not a fit: Patients who are not fluent in English or French and unwilling to complete the required questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most cost-effective treatment strategies for high-risk patients with chronic lymphocytic leukemia.
How similar studies have performed: Other studies have explored similar economic analyses in cancer treatment, indicating potential for valuable insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vancouver, British Columbia and 7 other locations
- BCCA - Vancouver — Vancouver, British Columbia, Canada (Recruiting)
- CancerCare Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- Regional Health Authority B, Zone 2 — Saint John, New Brunswick, Canada (Recruiting)
- QEII Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
- Lakeridge Health Oshawa — Oshawa, Ontario, Canada (Not_yet_recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
- The Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- Allan Blair Cancer Centre — Regina, Saskatchewan, Canada (Recruiting)
Study contacts
- Study coordinator: Annette Hay
- Email: ahay@ctg.queensu.ca
- Phone: 613-533-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.