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Winston-Salem, North Carolina 27157


Purpose:

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.


Study 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.


Criteria:

Inclusion Criteria: - Patients must have a pathology confirmed diagnosis of one of the following: myelodysplastic syndrome (MDS); acute leukemia; multiple myeloma; myelofibrosis; lymphoma; chronic anemia; sickle cell anemia - Iron score >= 2 - Absolute Neutrophil Count (ANC) >= 1,000 - Platelets >= 50,000 - Albumin >= 2 g/dL - Alkaline phosphatase =< 5X Upper Limit of Normal (ULN) - Total bilirubin =< 1.5 - Creatinine =< 2X age-appropriate Upper Limit of Normal (ULN) OR creatinine clearance >= 40 ml/min - Serum Glutamic Oxaloacetic Transaminase (SGOT) [AST] and Serum Glutamic Pyruvic Transaminase (SGPT) [ALT] =< 5X Upper Limit of Normal (ULN) - Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Patients with active disease undergoing chemotherapy treatment - Patient who have been treated with rituximab or immunomodulating drugs =< 1 month prior to enrollment - HIV-positive patients - Hepatitis-C positive patients - Women who are pregnant or breastfeeding - Patients on hemodialysis/patients with renal failure - Patients with sepsis or acute illness - Known hypersensitivity to deferasirox - Patients with moderate or severe hearing loss as defined by audiogram


NCT ID:

NCT01273766


Primary Contact:

Principal Investigator
Mary Ann Knovich, MD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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