GP28331 - A PHASE Ib study - CHRONIC LYMPHOCYTIC LEUKAEMIA
Research type
Research Study
Full title
A PHASE 1b MULTICENTER DOSE-FINDING AND SAFETY STUDY OF VENETOCLAX AND OBINUTUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCTYIC LEUKEMIA
IRAS ID
110569
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2012-002038-34
ISRCTN Number
n/a
Research summary
GDC-0199 and obinutuzumab are investigational drugs. The purpose of this phase Ib study is to determine if the combination of GDC-0199 at various dose levels and obinutuzumab is safe and well tolerated and to determine the effects, good and/or bad, this combination of medicines have on patients with relapsed/refractory or previously untreated Chronic Lymphocytic Leukaemia (CLL). CLL is cancer of a type of white blood cells called Lymphocytes. Relapsed/refractory means that the CLL has returned or is not responding.
Appproximately 46 to 64 patients will be enrolled in this study at hospitals in the U.S. and Europe.
There will also be optional additional genetic research on blood samples from patients that might help researchers to understand more about CLL and related diseases and why people do or do not respond to treatments.
The Sponsor of this research study is Genentech Inc.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
12/YH/0475
Date of REC Opinion
14 Jun 2013
REC opinion
Further Information Favourable Opinion