A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
The primary objective for the phase I part of the study is to investigate the safety and
tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in
participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell
chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective
for the phase II part of the study is to investigate the efficacy and safety of one dose of
obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either
indolent (iNHL) or aggressive (aNHL).
It is an open label dose escalating study in phase I and open label in phase II, but the two
doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment).
CLL was not randomized as only one dose level was used.
Participants with a response who might gain additional benefit from being treated again in
the opinion of the investigator may be enrolled in a Retreatment Period.