A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma
There is a 21 day screening period followed by 28 day cycles. Patients will continue to
receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion
is met. The last posttreatment visit will be 30 days after the last dose or until
IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
2 months to 2 years
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
ARD12130
NCT01403636
October 2011
July 2014
Name | Location |
---|---|
Investigational Site Number 840104 | Sarasota, Florida 34236 |
Investigational Site Number 840015 | Columbia, Missouri 65201-8104 |
Investigational Site Number 840004 | Boston, Massachusetts 02115 |
Investigational Site Number 840012 | San Francisco, California 94143 |
Investigational Site Number 840018 | Hot Springs, Arkansas 71913 |
Investigational Site Number 840006 | Augusta, Georgia 30912 |
Investigational Site Number 840011 | Maywood, Illinois 60153 |
Investigational Site Number 840013 | Lexington, Kentucky 40536 |
Investigational Site Number 840007 | Paducah, Kentucky 42002 |
Investigational Site Number 840017 | Lebanon, New Hampshire 03756 |
Investigational Site Number 840009 | Valhalla, New York 10595 |
Investigational Site Number 840014 | Canton, Ohio 44718 |
Investigational Site Number 840001 | Philadelphia, Pennsylvania 19111 |
Investigational Site Number 840002 | Morgantown, West Virginia 26506 |
Investigational Site Number 840010 | Kansas City, Kansas 66160-7321 |