Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
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.
Checked against the public recordLast updated Sep 7, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Drug: deferasirox; Other: laboratory biomarker analysis; Other: enzyme-linked immunosorbent assay
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 7, 2018. Always confirm current availability with the study team.