GO28667 - PH III, OPEN-LABEL, IN RELAPSED/REFRACTORY PATIENTS WITH CLL
Research type
Research Study
Full title
A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199) PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB
IRAS ID
141471
Contact name
Martin Dyer
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2013-002110-12
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
The purpose of this study is to test the effects, good and bad, of the combination of GDC-0199 with rituximab versus a standard treatment regimen, bendamustine plus rituximab, on patients with chronic lymphocytic leukemia (CLL) to find out which is more beneficial. GDC-0199 is an experimental drug that blocks the function of a protein called Bcl-2. Bcl-2 is a “pro-survival” protein that helps cells survive and resist the effects of anti-cancer treatments. It is thought that by blocking the function of Bcl-2, GDC-0199 could kill CLL cells and/or make them more vulnerable to the effects of other anti-CLL treatments. GDC-0199 is an experimental drug, which means that health authorities have not approved GDC-0199.
Approximately 370 patients will be enrolled and randomly assigned 1:1 to receive either GDC-0199 plus rituximab (GDC-199+R) or bendamustine plus rituximab (BR).
Patients randomised to Arm A (GDC-199+R) will have a 4 - 5 week GDC-0199 dose ramp-up period to reach the target dose of 400 mg daily. Following the GDC-0199 ramp-up period, patients will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Patients will continue to take their daily dose of GDC 0199 during the rituximab cycles. Patients who have not progressed following the completion of the 6 cycles will continue to receive GDC-0199 until disease progression or for a maximum of 2 years from Cycle 1 Day 1.
Patients randomised to Arm B (BR) will receive 6 cycles of BR consisting of a single infusion of rituximab on Day 1 and bendamustine infusions on Days 1 and 2 of each 28 day cycle.
After completion of the 6 cycles, patients will continue to be followed up until progression or study end.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/0034
Date of REC Opinion
22 Apr 2014
REC opinion
Further Information Favourable Opinion