Clinical Trial: Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome: Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only) [ Time Frame: Baseline, up to 6 months ]
Original Primary Outcome: Changes in neutrophil function including respiratory burst activity, lymphocyte function, and macrophage function [ Time Frame: Approximately 6 months ]
Current Secondary Outcome:
- Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics [ Time Frame: Baseline, up to 6 months ]Records will be assessed at baseline and prospectively while on study.
- Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections [ Time Frame: Baseline, up to 6 months ]Records will be assessed at baseline and prospectively while on study.
Original Secondary Outcome:
- Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics [ Time Frame: Approximately 6 months ]Records will be assessed at baseline and prospectively while on study.
- Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections [ Time Frame: Approximately 6 months ]Records will be assessed at baseline and prospectively while on study.
Information By: Wake Forest University Health Sciences
Dates:
Date Received: January 7, 2011
Date Started: January 2011
Date Completion:
Last Updated: January 17, 2017
Last Verified: December 2014