Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

You may be eligible if

• Inclusion
• Patients must have undergone a matched related donor, matched unrelated donor or cord blood Hematopoietic Stem Cell Transplant (HSCT) over 6 months ago
• Patients currently on Desferal (desferrioxamine) therapy will require a one day wash out prior to the first dose of study drug
• Serum ferritin \>= 1500 ng/mL on two occasions two weeks apart at screening; samples must be obtained in the absence of concomitant infection
• Normal C-reactive protein level at screening
• Patients must be red cell transfusion independent for 2 months prior to enrollment
• Sexually active women must use an effective method of contraception, or must have undergone clinical documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
• Written informed consent by the patient
• Exclusion
• Chronic hepatic GVHD with serum total bilirubin over 2 mg/dL
• Known hypersensitivity to deferasirox
• Serum creatinine above the upper limit of normal
• AST or ALT \> 200 U/L during screening
• Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)
• History of HIV positive test result (ELISA or Western blot)
• History of drug or alcohol abuse within the 12 months prior to enrollment
• ECOG Performance Status \> 2
• Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
• Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
• Pregnancy (as documented in required screening laboratory test) or breast feeding
• Patients who received treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days or are planning to receive other investigational drugs while participating in the study
• Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
• History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative