Discontinuing BTK Inhibitors for CLL

(STOP-CLL-DCT Trial)

Overseen By Katelyn Dempsey

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Must be taking: Bruton tyrosine kinase inhibitors

Disqualifiers: Progressive CLL

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase II hybrid decentralized multicenter study examines the outcomes of stopping Bruton tyrosine kinase inhibitor (BTKi) therapy in patients with chronic lymphocytic leukemia (CLL) who have remained in remission for at least two years. The primary objective is to determine how long patients remain free from disease progression or death after discontinuing treatment, measured as event free survival.

The study also evaluates whether stopping BTKi therapy leads to improvements in quality of life and reductions in treatment related side effects. Researchers will follow patients over time to assess if the cancer returns, whether resistance to therapy develops, and how patients feel during the treatment free period.

In addition, the trial will investigate how discontinuing BTKi therapy affects immune function, including whether immune recovery occurs and infection risk decreases.

Preliminary data indicate that patients may experience a treatment free interval exceeding two years after stopping therapy, with associated improvements in quality of life. By prospectively evaluating a time limited treatment strategy, this trial aims to determine whether durable disease control can be maintained off therapy while also assessing the resolution of BTKi related adverse events and changes in patient reported outcomes.

Overall, the study seeks to determine whether patients can safely discontinue BTKi therapy and potentially restart treatment later if needed, thereby maintaining disease control while reducing the burden of continuous therapy.

Who Is on the Research Team?

Deborah Stephens, DO

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

Subject is willing and able to comply with study procedures based on the judgement of the investigator

I am 18 years old or older.

Exclusion Criteria

My CLL is not currently getting worse.

I have or had other cancers besides CLL/SLL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment-Free Interval

Participants discontinue BTKi therapy and are monitored for event-free survival and quality of life improvements

2 years

Follow-up

Participants are monitored for safety, immune function, and disease progression after discontinuation of BTKi therapy

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Bruton tyrosine kinase inhibitors (BTKi)

How Is the Trial Designed?

Group I: Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Experimental Treatment 1 Intervention

Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have been receiving covalent Bruton tyrosine kinase inhibitors for at least 2 years and have achieved a clinical remission.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+