Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare The Efficacy and Safety of Lenalidomide (CC-5013) Plus R-Chop Chemotherapy (RS-CHOP) in Subjects with Previously Untreated Activated B-Cell Type Diffuse Large B-Cell Lymphoma
Sponsor: |
TG Therapeutics |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAP1757 |
U.S. Govt. ID: |
NCT02285062 |
Contact: |
Michelle Malanga: 212-326-5720 / mm4629@cumc.columbia.edu |
This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is not approved for use in DLBCL. Its use in this disease is experimental. In this study, the experimental treatment is lenalidomide + R-CHOP21 x 6. This study will use a gene expression profile (GEP) test to see if a patient has the ABCtype. The results of this GEP test affect whether you may be treated on this study. Because the performance of this test has not been proven, this test is for investigational use only, and is still under development. This means the GEP test is considered an experimental test.
This study is closed
Investigator
Owen O'Connor, MD, PhD
Have you been diagnosed diffuse Large B-Cell Lymphoma? |
Yes |
No |