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

NCT07526597 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: LCCC2522-DCT
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Keywords

Bruton's tyrosine kinase inhibitors (BTKi)

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  EFS will be defined as the proportion of patients who remain alive, do not meet International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for initiation of next chronic lymphocytic leukemia (CLL) therapy, and have not started a new CLL - directed treatment.

  2 years

Secondary Outcomes (10)

• Progression Free Survival (PFS)

  2 years

• Overall Survival (OS)

  Up to 60 months

• Time to initial detection of measurable residual disease (MRD)

  Up to 60 months

• Overall and complete response rates

  2 years

• Rate of resolution of BTKi-related adverse events

  2 years

Study Arms (1)

Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

OTHER

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.

Other: Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy

Interventions

Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy OTHER

Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy.

Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
• Age ≥ 18 years at the time of consent.
• Eastern Cooperative Oncology Group Performance Status of 0-3 or Karnofsky Performance Status of ≥40
• Confirmed of a diagnosis of CLL (Chronic Lymphocytic Leukemia) or SLL (Small Lymphocytic Lymphoma) according to International Workshop on Chronic Lymphocytic Leukemia 2018 Guidelines at any point prior to study enrollment.
• At the time of enrollment, patients must be receiving treatment with a covalent Bruton tyrosine kinase inhibitor in the first or second line setting and have been receiving this treatment for at a minimum 2 years. Patients may have previously received anti-CD20 monoclonal antibodies (such as rituximab or obinutuzumab) in combination with the cBTKi.

You may not qualify if:

• Patients must not have evidence of progressive CLL as defined by IWCLL 2018 criteria.
• Participants with history of malignancy other than CLL/SLL are allowed

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah Stephens, DO

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brice Messenger

CONTACT

919-984-0000; brice_messenger@med.unc.edu

Katelyn Dempsey

CONTACT

919-984-0000; katelyn_dempsey@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)