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NCT07526597 · ClinicalTrials.gov registry record · Phase 2
Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT07526597: Clinical Trial Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT07526597 is a Phase 2 study that has not yet begun recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07526597, a Phase 2 study, has not yet begun recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2026-07 |
| Est. Completion | 2032-06 |
| Phase | Phase 2 |
What is known before NCT07526597 opens enrollment
NCT07526597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy is the first listed.
NCT07526597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07526597 about?
NCT07526597 is a clinical study titled "Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors". 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 re...
What is the current status of trial NCT07526597?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2026-07. Estimated completion is 2032-06.
What interventions are being tested in trial NCT07526597?
The interventions under investigation include: Discontinuing Bruton tyrosine kinase inhibitors (BTKi) therapy (OTHER).
Who is sponsoring clinical trial NCT07526597?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07526597's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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