|MDACC Study No:||2012-0411 (clinicaltrials.gov NCT No: NCT01569295)|
|Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia|
|Principal Investigator:||Susan O'Brien|
|Treatment Agent:||Bendamustine HCl; GS-1101; Rituximab|
|Study Description:||The goal of this clinical research study is to find out if adding GS-1101 to |
standard treatment with rituximab and bendamustine is more effective than
standard treatment plus a placebo, in controlling CLL. The safety of these 2
treatment combinations will also be studied.
GS-1101 is designed to block one of the signals inside the cells that may cause
cancer to grow and survive. By blocking this signal, GS-1101 may reduce the
cancer or prevent it from growing and surviving.
Bendamustine is designed to damage and destroy the DNA (genetic material) of
Rituximab is designed to attach to cancer cells and damage them, which may
cause the cells to die.
A placebo is not a drug. It looks like the study drug but is not designed to
treat any disease or illness. It is designed to be compared with a study drug
to learn if the study drug has any real effect.