A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

Summary

The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus rituximab in adult Asia Pacific region patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Timeline

Start

2013-10-28

Primary completion

2015-12-01

Completion

2017-08-11

Outcome

Met primary endpoint

registry MEDIAN Ibrutinib: NA (NA to NA) months MEDIAN Rituximab: 8.38 (8.31 to 9.03) months NCT01973387 ↗

registry Ibrutinib vs Rituximab; p <0.0001; Hazard Ratio (HR) 0.178 (95% CI 0.109 to 0.291); Log Rank NCT01973387 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	420 mg	Oral
Subject	Rituximab	Monoclonal antibody	500 mg/m2	Intravenous

Indications