RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant. PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.
OBJECTIVES: Primary * To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation. Secondary * To evaluate the efficacy of deferasirox in reducing liver iron overload in these patients. OUTLINE: This is a multicenter study. Patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
20 mg/kg once daily orally for 6 months
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Number of Patients Not Completing Treatment
Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity
Time frame: 6 Months
Reduction in Liver Iron Concentration After Study Drug
Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.
Time frame: 6 Months
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