A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with overall response
Overall response rate (ORR) by central review + progression free survival (PFS)
Change from screening period in response assessed at the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
No
Medical Monitor
Study Director
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
C14012
NCT01482962
April 2012
April 2017
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Fletcher Allen Health Care | Burlington, Vermont 05401 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |
Columbia Comprehensive Cancer Care Clinic | Columbia, Missouri 65201 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Methodist Hospital | Houston, Texas 77030 |
University of Virginia | Charlottesville, Virginia 22908 |
Duke University Medical Center | Durham, North Carolina 27710 |
Henry Ford Health System | Detroit, Michigan 48202 |
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |
UCLA | Los Angeles, California 90095 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Columbia University Medical Center | New York, New York 10032 |
Mayo Clinic Rochester | Rochester, Minnesota 55905 |
Weill Cornell Medical College | New York, New York 10021 |
University of Iowa Hospitals & Clinics | Iowa City, Iowa 52242 |
SUNY Upstate Medical Center | Syracuse, New York 13210 |
Mercy St. Vincent Medical Center | Toledo, Ohio 43608 |
ProMedica Health System, Inc. | Toledo, Ohio 43606 |
AMPM Research Clinic | Miami, Florida 33145 |
Dartmouth | Lebanon, New Hampshire 03755 |
Seattle Cancer Care | Seattle, Washington 98109 |