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

Last updated: August 7, 2018
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

2

Condition

Multiple Myeloma

Aplastic Anemia

Post-polycythemia Vera Myelofibrosis

Treatment

N/A

Clinical Study ID

NCT01273766
IRB00015287
NCI-2010-02228
CCCWFU 97710
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 PyruvicTransaminase (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 forthe duration of study participation; should a woman become pregnant or suspect she ispregnant while participating in this study, she should inform her treating physicianimmediately

  • Ability to understand and the willingness to sign a written informed consent document

Exclusion

Exclusion Criteria:

  • Patients with active disease undergoing chemotherapy treatment

  • Patient who have been treated with rituximab or immunomodulating drugs =< 1 monthprior 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

Study Design

Total Participants: 16
Study Start date:
January 01, 2011
Estimated Completion Date:
December 31, 2014

Study 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.

Connect with a study center

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.