A Multi-center, Phase 2, Single-Arm, Open-Label Exploratory Study of Individually- Optimized Conditioning Using Pharmacokinetics [PK]-Directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in Subjects With Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma
Evaluation of progression-free survival, transplant related mortality, overall survival, and
overall response rate, in subjects with NHL and HL receiving an IV busulfan-based
conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well
as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM)
conditioning regimen (and its variants) obtained from registry data in the Center for
International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile
of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be
completed.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
3 years
No
Agnes Elekes, MD
Study Director
Otsuka Pharmaceutical Development and commercialization
United States: Food and Drug Administration
273-08-201
NCT00948090
January 2010
July 2013
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Scripps Clinic | La Jolla, California 92037 |
Sutter Cancer Center | Sacramento, California 95816 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
Baylor University Medical Center | Dallas, Texas 75246 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
Emory University | Atlanta, Georgia 30322 |
The Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
University of California, Davis Medical Center | Sacramento, California |
Virginia Commonwealth University | Richmond, Virginia |
The University of Chicago | Chicago, Illinois 60637 |
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Weill Cornell Medical College | New York, New York 10021 |
South Texas Veterans Health Care System | San Antonio, Texas 78229 |
University of California San Francisco Medical Center | San Francisco, California 94143 |
West Virginia University Hospital | Morgantown, West Virginia 26506-9162 |
Alta Bates Summit Medical Center | Berkeley, California 94704 |
Loyola University Chicago | Maywood, Illinois 60153 |
Montefiore-Einstein Cancer Center | Bronx, New York 10461 |
University of Alabama in Birmingham | Birmingham, Alabama 35294 |
UCSD Medical Center BMT Program | La Jolla, California 92093 |
Bone Marrow and Stem Cell Transplant Program | Indianapolis, Indiana 46202 |
LSU Health Sciences Center at Shreveport/Feist Weiller Cancer Center | Shreveport, Louisiana 71103 |
University of Maryland Medical Center - Marlene & Stewart Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Texas Transplant Physician Group, PLLC | San Antonio, Texas 78229 |