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

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studieddeferasirox and laboratory biomarker analysis

Plus 1 other study approaches.

Who it may be forEarly-stage or resectable · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 7, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

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

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How this study is categorized

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

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→Recurrent or relapsed→Resistant or refractory→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

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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