NCT00602446

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

Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Iron Overload
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Neuroblastoma
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	deferasirox	20 mg/kg once daily orally for 6 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2008-01-28
• Last updated: 2017-12-28
• Results posted: 2010-03-30

Locations

1 site across 1 country: United States