Clinical trial NCT00602446 (phase 2, status: terminated)
Conditions: breast cancer, iron overload, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, neuroblastoma, ovarian cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, E87.70, E87.79, E87.71, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C96.20, C96.29, D47.09, D46.9, D46.C, D46.Z, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: deferasirox
SMILES: CC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCN
Reason stopped: 
    due to slow accrual of patients
  
Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of iron overload, defined as serum ferritin > 1,000 ng/mL and
             liver iron concentration ≥ 5 mg iron/g on tissue proton transverse relaxation rates
             Magnetic Resonance Imaging (MRI)

          -  Underwent prior allogeneic hematopoietic stem cell transplantation (HSCT) using either
             myeloablative or reduced-intensity conditioning at least 12 months ago

          -  No evidence of relapse or progression of the primary disease for which allogeneic HSCT
             was performed

          -  Patients who have become red-cell transfusion independent (i.e., no red cell
             transfusions within the past 3 months) as well as patients who require red cell
             transfusions are eligible

          -  Meets one of the following criteria:

               -  Ineligible for phlebotomy (hemoglobin < 11 g/dL, poor intravenous access, or
                  unable to undergo phlebotomy every 4 weeks)

               -  Have failed treatment with phlebotomy (serum ferritin > 50% of baseline after 3
                  months of phlebotomy)

               -  Refused phlebotomy

          -  ECOG performance status of 0-2

          -  Life expectancy ≥ 6 months

          -  Adequate renal function defined as serum creatinine < or = 1.6 mg/dL and creatinine
             clearance of > or = 60 ml/min calculated using the Crockcroft-Gault formula on 2
             occasions within 30 days of enrollment

          -  Sexually active men and women must use an effective method of contraception.
             Alternatively, women must have undergone clinically documented total hysterectomy
             and/or oophorectomy, or tubal ligation or be postmenopausal.

          -  Must be able to give written informed consent.

          -  Prior therapy with deferoxamine allowed provided it was completed ≥ 12 months ago

        Exclusion Criteria:

          -  Contraindication for performing MRI or inability to undergo MRI because of
             claustrophobia or weight (>350 pounds).

          -  Inability to take medications orally.

          -  Uncontrolled bacterial, viral, or fungal infection

          -  ANC ≥ 1,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL

          -  Platelet count ≥ 50,000/mm³

          -  Aspartate aminotransferance (AST) and alanine aminotransferase (ALT) ≤ 5 times the
             upper limit of normal

          -  Less than 4 weeks since prior and no concurrent systemic investigational drug

          -  Less than 7 days since prior and no concurrent topical investigational drug.
             Concurrent non-investigational medications needed to treat concomitant medical
             conditions are allowed, with the exception of other chelating agents. Concurrent
             growth factors such as epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), and
             sargramostim (GM-CSF) allowed. Concurrent irradiated packed red-cell and platelet
             transfusions allowed as clinically indicated. Concurrent low-doses of vitamin C
             supplements (≤ 200 mg/day) allowed.

          -  Concurrent iron supplements or multivitamins with iron.

          -  Aluminum-containing antacid therapies may not be taken simultaneously with
             deferasirox, but may be taken 2 hours before or after administration of deferasirox

          -  On dialysis or status post-renal transplantation

          -  Pregnant or nursing