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 ]

Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)


Original Primary Outcome: Changes in neutrophil function including respiratory burst activity, lymphocyte function, and macrophage function [ Time Frame: Approximately 6 months ]

Iron profile will be completed at baseline and at each dosing of deferasirox.


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