A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
Status:
Active, not recruiting
Trial end date:
2023-02-04
Target enrollment:
Participant gender:
Summary
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.