Non Hodgkin Lymphoma Clinical Trial
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
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