Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
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.
|Breast Cancer Iron Overload Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer||Drug: deferasirox||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload|
- Number of Patients Not Completing Treatment [ Time Frame: 6 Months ]Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity
- Reduction in Liver Iron Concentration After Study Drug [ Time Frame: 6 Months ]Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.
|Study Start Date:||August 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Deferasirox Treated
Includes patients that were treated with deferasirox for 6 months.
20 mg/kg once daily orally for 6 months
Other Name: Exjade
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602446
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Linda J. Burns, MD||Masonic Cancer Center, University of Minnesota|