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Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload
RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.
PRIMARY OBJECTIVES: I. To determine the effects of the iron-chelating agent deferasirox on changes in: neutrophil function; macrophage function; lymphocyte function. SECONDARY OBJECTIVES: I. To determine the effect of chelation on the incidence of bacterial, viral and fungal infections documented by clinical, microbiologically-proven versus radiologically-proven criteria. II. To determine the effect of iron chelation on mortality and morbidity with incidence of the following parameters: Need for hospitalization; Duration of hospitalization; Need for ventilatory support; Need for exchange transfusion/apheresis; Need for treatment with antifungals or antibiotics for documented infections. OUTLINE: Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Start Date
January 1, 2011
Primary Completion Date
March 1, 2012
Completion Date
December 1, 2014
Last Updated
September 7, 2018
16
ACTUAL participants
deferasirox
DRUG
laboratory biomarker analysis
OTHER
enzyme-linked immunosorbent assay
OTHER
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT02159495
NCT02793544
Data Source & Attribution
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