A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL

This is a pilot phase 2 study investigating the safety and efficacy of ibrutinib combined with short-course fludarabine in previously untreated CLL patients. Ibrutinib will be given daily until disease progression or intolerable side effects occur. Fludarabine will be given in cycles 3 and 4. The primary efficacy endpoint is the rate of complete response after 6 cycles or 24 weeks. The primary safety endpoint is the rate of treatment discontinuation after 6 cycles or 24 weeks.

NCT Number	NCT02514083
Lead Sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment	29 participants
Start Date	2015-12-09
Primary Completion	2019-10-02 (estimated)
Study Completion	2034-10-23 (estimated)
Updated on ClinicalTrials.gov	2026-04-14