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

Canadian Cancer Trials Group

Status: Enrolling

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Other: Resource Utilization Form (SMRC); Other: Work Productivity and Daily Activity Impairment (WPAI) survey; Other: EQ-5D-5L Instrument

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05371808

CLC3E

Details and patient eligibility

About

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.

Enrollment: 247 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.