drugset / Trial / NCT01292135

Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)

NCT01292135

Phase 1 Completed 33 enrolled Pharmacyclics LLC.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).

Timeline

Start
2011-02
Primary completion
2012-11
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral