Study Comparing BTKi Alone Versus BTKi Plus Venetoclax for Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in Veterans

What this Trial Is About

This trial involves people with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who are currently treated with oral medications called Bruton Tyrosine Kinase Inhibitors BTKi, such as ibrutinib, acalabrutinib, or zanubrutinib. Researchers are studying whether adding another pill called venetoclax to the ongoing BTKi treatment for one year helps control the disease better and allows patients to stop treatment safely. The study also evaluates side effects, quality of life, and how the combination affects Veterans specifically. Participants are randomly assigned to one of two groups one continues BTKi treatment alone, and the other adds venetoclax to BTKi for 12 cycles and then stops both pills after one year. Both groups are monitored closely after treatment to track responses and side effects. The study treatments are provided at no cost, and about 50 people will be in each group. During the study, participants will have regular assessments including blood tests, imaging, and patient questionnaires to measure disease response, side effects, quality of life, and fatigue levels. Researchers will evaluate the complete response rate using established criteria over 24 to 36 months. Safety and financial impacts will also be tracked. Participation lasts from the start of treatment through follow-up, with ongoing monitoring after therapy stops to understand long-term outcomes.

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)