Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Deferasirox Treatment and Labile Plasma Iron in Iron Overloaded Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation
RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have
undergone hematopoietic stem cell transplant and have iron overload.
PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in
hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose
deferasirox on labile plasma iron is also examined.
PRIMARY OBJECTIVES:
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
setting.
SECONDARY OBJECTIVES:
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
treatment period.
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.
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