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

August 7, 2018 updated by: Wake Forest University Health Sciences

Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I
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.
Other: laboratory biomarker analysis
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Names:
  • ELISA
Drug: deferasirox
Given orally
Other Names:
  • Exjade
  • ICL670
NO_INTERVENTION: control arm
blood tested on healthy patients
NO_INTERVENTION: correlative
treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)
Time Frame: Baseline, up to 6 months
Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
Baseline, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Time Frame: Baseline, up to 6 months
Records will be assessed at baseline and prospectively while on study.
Baseline, up to 6 months
Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections
Time Frame: Baseline, up to 6 months
Records will be assessed at baseline and prospectively while on study.
Baseline, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mary Ann Knovich, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (ESTIMATE)

January 10, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00015287
  • NCI-2010-02228 (OTHER_GRANT: NCI)
  • CCCWFU 97710 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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