Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant

Stopped early · Phase 2

Conditions studied: Breast Cancer, Iron Overload, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Neuroblastoma, Ovarian Cancer

In brief

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.

Key facts

Study ID: NCT00602446
Run by: Masonic Cancer Center, University of Minnesota
People needed: 4
Starts: 2007-08-01
Expected to finish: 2009-12-01
Last updated by the study team: 2017-12-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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