drugset / Trial / NCT01868893

An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT01868893

Phase 2 Completed 20 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.

Timeline

Start
2013-08
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Background Chlorambucil Other / unclassified 0.5 mg/kg Oral