CLINICAL TRIAL SUMMARY

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 Status:Open
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
cancer cells.

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.

Hide details for General InformationGeneral Information

Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:Bendamustine HCl
GS-1101
Rituximab
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Gilead Sciences, Inc.
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Susan O'Brien
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7543
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults