Deferasirox Treatment and Labile Plasma Iron in Iron Overloaded Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
I. To determine labile plasma iron (LPI) levels in iron overloaded patients after allogeneic
Hematopoietic Stem Cell Transplantation (HSCT).
II. To determine safety and tolerability of low dose deferasirox in the post allogeneic HSCT
I. To determine ability of deferasirox to suppress LPI in allogeneic HSCT patients with
serum ferritin over 1500 ng/ml.
II. To determine prevalence of elevated LPI in allogeneic HSCT recipients with serum
ferritin over 1500 ng/ml.
III. To determine ability of low dose deferasirox to lower serum ferritin during the
IV. To correlate LPI with serum ferritin in allogeneic HSCT recipients with serum ferritin
over 1500 ng/ml.
OUTLINE: Patients receive deferasirox at 10 mg/kg once daily for 6 months in the absence of
unacceptable toxicity. Labile plasma iron will be measured at baseline and at weeks 4, 12,
and 24. Side effects of deferasirox will be recorded.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Safety and tolerability of low dose deferasirox in the post allogeneic hematopoietic stem cell transplant setting
Safety and tolerability will be assessed based upon laboratory evaluations, physical examinations, vital signs and monitoring for adverse events.
Assessed through 6 months from the start of treatment
Myo Htut, MD
Beckman Research Institute
United States: Institutional Review Board
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