A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
the incidence of grade 3/4 oral mucositis using WHO grading system
evaluated throughout the study
No
United States: Food and Drug Administration
CG53135-CLN-12
NCT00323518
May 2006
August 2008
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Roger Williams Medical Center | Providence, Rhode Island 02908-4735 |
Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Baylor University Medical Center | Dallas, Texas 75246 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
University of Oklahoma | Oklahoma City, Oklahoma 73190 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
University of Colorado Health Sciences Center | Denver, Colorado 80262 |
Cornell Medical Center | New York, New York 10021 |
Emory University | Atlanta, Georgia 30322 |
Wayne State University | Detroit, Michigan 48202 |
University of Texas Health Science Center | San Antonio, Texas 78284 |
Oregon Health and Science University | Portland, Oregon 97201 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
Biomedical Research Alliance of New York | New York, New York 10016 |
Medical University of South Carolina Hollings Cancer Center | Charleston, South Carolina 29425 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Rocky Mountain Blood and Marrow Transplant Program | Denver, Colorado 80218 |
Research Facility | La Jolla, California 92037 |
Scripps Green Medical Center | La Jolla, California 92037 |
Legacy Good Samaritan Hospital and Cancer Center | Portland, Oregon 97227 |
Fox Chase-Temple Bone Marrow Transplant Program | Philadelphia, Pennsylvania 19111 |
Medical College of Wisonsin | Milwaukee, Wisconsin 53226 |