A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
This is an open-label, multicenter, single arm efficacy and safety study in patients with
relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior
systemic therapy.
Approximately 120 patients will be enrolled. Patients will be treated with 1000 mg/m²
belinostat administered as a 30-minute IV infusion on days 1-5 of every 3-week cycle until
there is disease progression or unmanageable treatment-related toxicities.
The primary study endpoint is objective response rate (ORR) based on the IHP revision IWG
criteria. Safety will be evaluated during the study and for 30 days after the last
administration of study drug. Adverse events and laboratory studies will be graded according
to NCI-CTCAE v. 3.0.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary - Objective response rate
December 2010
No
Peter Brown, MD
Principal Investigator
H:S Rigshospitalet, Department of Hematology, Denmark
United States: Food and Drug Administration
PXD101-CLN-19
NCT00865969
December 2008
December 2013
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Kellogg Cancer Care Center | Highland Park, Illinois 60035 |
Saint Louis University | St. Louis, Missouri 63104 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Cascade Cancer Center | Kirkland, Washington 98034-3013 |
Henry Ford Health System | Detroit, Michigan 48202 |
Comprehensive Cancer Center | Glendale, California 91204 |
Associates in Oncology and Hematology | Chattanooga, Tennessee 37404 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Northern New Jersey Cancer Associates | Hackensack, New Jersey 07601 |
New York University | New York, New York 10016 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Oncology Associates of Bridgeport | Trumball, Connecticut 06611 |
Monter Cancer Center | Lake Success, New York 11042 |
Boston University Medical Center | Boston, Massachusetts 02118 |
New York University Cancer Institute | New York, New York 10016 |
Wilshire Oncology Medical Group, Inc | LaVerne, California 91750 |
Penn State Hershey Cancer Institute | Hershey, Pennsylvania 17033 |
Avera Cancer Center | Sioux Falls, South Dakota 57105 |
Yale Cancer Center-Section of Medical Oncology | New Haven, Connecticut 06520 |
Boca Raton Clinical Research Associates | Boca Raton, Florida 33432 |
Center for Cancers and Blood Disorders | Bethesda, Maryland 20817 |
Bronx River Medical Associates, PC | Bronx, New York 10467 |
Erie County Medical Center (Roswell Park) | Buffalo, New York 14215 |
Upstate Medical Univeristy Syracuse | Syracuse, New York 13210 |
Hematology Associates | Bedford, Ohio 44146 |
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN) | Memphis, Tennessee 38138 |
UT - M. D. Anderson Cancer Center | Houston, Texas 77030 |
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Georgia Health Sciences University | Augusta, Georgia 30912 |
Illinois CancerCare, P.C. | Bloomington, Illinois 61701 |
Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
St Luke's Cancer Center | Bethlehem, Pennsylvania 18015 |
The UT Health Science Centre at San Antonio | San Antonio, Texas 78229 |