At a glance
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A Pilot Phase II Study Using Ibrutinib and Short-Course Fludarabine in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
In Brief
A Phase 2 clinical trial evaluating Ibrutinib and Fludarabine for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Active but no longer recruiting, targeting 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Ibrutinib 420mg PO daily for the duration of the study.
Fludarabine 25 mg/m2/day IV on days 1-5 of cycles 3 and 4