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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Deferasirox

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