Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07526597
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy — OTHER
    Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
    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.

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599
Brice Messenger
[email protected]
919-984-0000
Deborah Stephens, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
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By specialty
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By research site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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