Trials / Completed

CompletedNCT01273766

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies

Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 16 (actual)

Sponsor: Wake Forest University Health Sciences · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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 description

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.

Conditions

Interventions

Type	Name	Description
DRUG	deferasirox	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	enzyme-linked immunosorbent assay	Correlative studies

Timeline

Start date: 2011-01-01
Primary completion: 2012-03-01
Completion: 2014-12-01
First posted: 2011-01-10
Last updated: 2018-09-07
Results posted: 2013-11-27

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT01273766. Inclusion in this directory is not an endorsement.