drugset / Trial / NCT06520098

A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT06520098

Phase 2 Recruiting 100 enrolled VA Office of Research and Development
RandomizedParallel-groupOpen-labelTreatment

Summary

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.

Timeline

Start
2025-10-01
Primary completion
2030-06-30
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule
Background Acalabrutinib Small molecule Oral
Background Ibrutinib Small molecule Oral
Background Zanubrutinib Small molecule Oral