Expired Study
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Minneapolis, Minnesota 55455


Purpose:

RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant. PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.


Study summary:

OBJECTIVES: Primary - To evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation. Secondary - To evaluate the efficacy of deferasirox in reducing liver iron overload in these patients. OUTLINE: This is a multicenter study. Patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 4 weeks.


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


NCT ID:

NCT00602446


Primary Contact:

Principal Investigator
Linda J. Burns, MD
Masonic Cancer Center, University of Minnesota


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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