Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes in neutrophil function including respiratory burst activity, lymphocyte function, and macrophage function
Iron profile will be completed at baseline and at each dosing of deferasirox.
Approximately 6 months
Mary Ann Knovich, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|