An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring
Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International
Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must
have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at
an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least
three complete blood count (CBC) values must be available for the 12 weeks prior to study
registration for patients with MDS and chronic iron overload from blood transfusions.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
12 month safety in patients with myelodysplastic syndrome (MDS)
throughout the study
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CICL670AUS03
NCT00110266
May 2005
March 2010
Name | Location |
---|---|
UCSF | San Francisco, California 941430324 |
Mayo Clinic | Rochester, Minnesota 55905 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Mayo Clinic | Jacksonville, Florida 32224 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
St. Agnes Healthcare | Baltimore, Maryland 21229 |
The Ohio State University | Columbus, Ohio 43210 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Roswell Park Cancer Center | Buffalo, New York 14263 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Mayo Clinic | Scottsdale, Arizona |
The Cleveland Clinic Foundation | Cleveland, Ohio |
Utah Cancer Specialists | Salt Lake City, Utah 84106 |
Bay Area Cancer Research Group | Concord, California 94520 |
The West Cancer Clinic | Memphis, Tennessee 38120 |
Cancer Care of WNC | Asheville, North Carolina 28801 |
Univ of Alabama Birmingham | Birmingham, Alabama 35294 |
Cedars-Sinai Medical Center, UCLA School of Medicine | Los Angeles, California 90048 |
Emory University School of Medicine/Winship Cancer Institute | Atlanta, Georgia 30322 |
University of Chicago Hospital | Chicago, Illinois 60637-1470 |
Novartis Investigative Site | Chicago, Illinois 60612 |
University of Kentucky College of Medicine, Markey Cancer Center | Lexington, Kentucky 40536-0093 |
Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital | Alexandria, Louisiana 71301 |
Rush Cancer Institute Univ. of Massachussets Medical Center | Worchester, Massachusetts 01605 |
Novartis Investigative Site | Southfield, Michigan 48075 |
The Center for Cancer Care & Research (TCCCR) | St. Louis, Missouri 63110 |
Oncology Hematology West, PC | Omaha, Nebraska 68124-2346 |
The Cancer Center at Hackensack University | Hackensack, New Jersey 07601 |
NMOHC | Albuquerque, New Mexico 87109 |
Rochester General Hospital/Lipson Cancer and Blood Center | Rochester, New York 14621 |
Wake Forest UniversitComprehensive Cancer Center | Winston Salem, North Carolina 27157-1082 |
Novartis Investigative Site | Portland, Oregon 97239 |
Thomas Jefferson University; Jefferson Medical College, Kimmel Cancer Center | Philadelphia, Pennsylvania 19107 |
Western Pennsylvania Hospital Cancer Institute | Pittsburgh, Pennsylvania 15224 |
Novartis Investigative site | Nashville, Tennessee 37232 |
Baylor/The Methodist Hospital | Houston, Texas 77030 |
Arlington Fairfax Hematology Oncology PC | Arlington, Virginia 22205 |
Novartis Investigative Site | Spokane, Washington 99202 |