Pilot Study of Intermittent Ibrutinib Dosing for Advanced Chronic Lymphocytic Leukemia CLL Exploring ON-OFF Cycles to Control CLL After Stable Partial Response

What this Trial Is About

Researchers are evaluating an intermittent dosing approach of ibrutinib, a drug used to treat advanced-phase chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL. The study explores whether stopping and restarting ibrutinib based on disease progression can maintain disease control while potentially reducing drug costs and side effects. This pilot study focuses on patients who have already received at least six months of ibrutinib and achieved a stable partial remission. Participants will follow an ON-OFF dosing schedule where ibrutinib is stopped after stable partial response and restarted upon clinical progression. The drug is given at the standard daily oral dose of 420 mg during ON periods, and cycles of treatment and off-therapy periods may be repeated until resistance, intolerance, or the need for continuous dosing arises. This approach is being tested to assess the feasibility of intermittent therapy. Throughout the study, participants will be monitored for safety by tracking adverse events over 1 to 24 months. Researchers will also evaluate response rates, time to partial remission, duration off therapy before restarting ibrutinib, cumulative dose, survival, risk of early disease rebound, and time until alternative treatments are needed. Participants will have regular visits for clinical assessments, laboratory tests, and adherence to the study schedule.

A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL)