CompletedPhase 2NCT01273766

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

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorWake Forest University Health Sciences
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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