Clinical trial NCT01965171: Transfusional Iron Overload Among Leukemia Survivors
Official title: Transfusional Iron Overload Among Leukemia Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Keywords: hematologic malignancy
iron overload
magnetic resonance imaging
childhood cancer survivors
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2013-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will have been treated at SJCRH for acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) and would have received ≥50 ml/kg of packed red blood cells during their treatment.

Brief summary: Red cell transfusions are an important part of supportive cancer therapy. The iron in the transfused blood may build up in the body since the human body has no way to get rid of extra iron. Iron tends to build up in the liver and the heart muscle. It is unknown if iron build-up is present many years after completing cancer therapy. It is also not known if extra iron causes harm to internal organs. Researchers at St. Jude Children's Research Hospital (SJCRH) want to understand if iron build-up (called "iron overload") exists in survivors of leukemia. They also want to know if iron overload can cause injury to your organs if it is present.

Liver iron accumulation has been documented in childhood cancer survivors, however, it is not known if iron associated organ toxicity is contributing to the long-term morbidity that has been well documented among these survivors. This study will investigate the prevalence of iron overload and the association of tissue iron burden with markers of organ dysfunction in leukemia survivors. This study will determine the prevalence of iron overload among long-term leukemia survivors that underwent blood transfusion. This study will use blood and magnetic resonance imaging (MRI) testing to determine iron overload of specified organs. Understanding the prevalence of iron overload could impact surveillance practices in leukemia survivors.

PRIMARY OBJECTIVE:

* To determine the prevalence of iron overload in the liver \[liver iron concentration (LIC) \>3mg/g using R2\* MRI measurements\] and in the heart (T2\* \<20 ms) among long-term leukemia survivors transfused with ≥50ml/kg of packed red blood cells.

SECONDARY OBJECTIVES:

* To examine the relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally acquired iron overload as defined by R2\* and T2\* MRI among survivors of pediatric leukemias.
* To investigate the association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin measurements with R2\* and T2\* MRI-defined iron overload.

Detailed description: Participants will have blood work drawn after an overnight fast during a routine clinic visit. They will also have an electrocardiogram (EKG) and echocardiogram (ECHO) which are often a required part of their annual visit. Magnetic resonance imaging (MRI) exams of the heart, liver, and surrounding abdominal organs will be done on all participants using a method of scanning that involves a closer study of these organs (called R2\* MRI).

Eligibility criteria: Inclusion Criteria:

* A diagnosis of ALL or AML that was treated at SJCRH with conventional chemotherapy.
* At time of enrollment survivors should be \> 5 and \< 10 years from diagnosis of primary cancer.
* A packed red blood cell transfusion history of ≥50 ml/kg.

Exclusion Criteria:

* Undergoing active cancer therapy for relapse or subsequent malignant neoplasm
* History of hematopoietic stem cell transplant (HSCT)
* A known disorder of iron regulation such as hereditary hemochromatosis
* Any contraindication to undergoing an MRI, such as the presence of ferromagnetic material in the body
* If patient is an adult (18 years or over), does require IV sedation or anxiolytic to undergo MRI
* Positive pregnancy test, or known ongoing pregnancy

Primary outcomes:
measure: Proportion of iron overload
timeFrame: On day of enrollment
Secondary outcomes:
measure: Relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally-acquired iron overload
timeFrame: On day of enrollment
measure: Association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron overload
timeFrame: On day of enrollment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Jane Hankins, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: