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

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