Brief Title
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
Official Title
Impact of Intervention With Deferasirox on the Immune Function of Patients With Hematologic Diseases and Transfusion-Related Iron Overload
Brief 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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)
Secondary Outcome
Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Condition
Acute Undifferentiated Leukemia
Intervention
deferasirox
Study Arms / Comparison Groups
Arm I
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
January 2011
Completion Date
December 2014
Primary Completion Date
March 2012
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mary Ann Knovich, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01273766
Organization ID
IRB00015287
Secondary IDs
NCI-2010-02228
Responsible Party
Sponsor
Study Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Mary Ann Knovich, MD, Principal Investigator, Wake Forest University Health Sciences
Verification Date
August 2018