A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload
See above
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.
All patients meeting the criteria for Severe iron overload as defined by BOTH: ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy.
Baseline , 6 month, 1 year
Yes
Philippe Armand, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
07-411
NCT00658411
August 2008
December 2011
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |