Timing of Therapy for Chronic Lymphocytic Leukemia

Recruiting at 8 trial locations

Overseen By Annette Hay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Disqualifiers: Unwillingness to complete questionnaires, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

247 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting treatment immediately or waiting affects health and costs in people newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma. Researchers will track healthcare use, such as doctor visits and hospital stays, to determine which approach might be better. Those diagnosed but not yet symptomatic might be suitable participants, especially if they can complete forms in English or French.

As a Phase 3 trial, this study serves as the final step before potential FDA approval, offering participants a chance to contribute to crucial research that could shape future treatment standards.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of therapy for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Instead of the usual approach of starting treatment once symptoms appear, this trial is investigating the benefits of starting therapy early, even when patients are still asymptomatic. This could potentially change the way CLL and SLL are managed by providing insights into whether early intervention could lead to better outcomes and cost-effectiveness compared to the standard "watch and wait" approach.

Who Is on the Research Team?

Matthew Cheung

Principal Investigator

Odette Cancer Centre, Sunnybrook Helath Sciences Centre, Toronto, Ontario, Canada

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either early or delayed therapy as part of the study

Varies

Includes study visits, radiographic assessments, laboratory investigations, and treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Includes protocol-specified and non-protocol specified visits

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+