Transfusional Iron Overload Among Leukemia Survivors
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 5/17/2017 |
| Start Date: | October 18, 2013 |
| End Date: | May 2017 |
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.
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.
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).
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).
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
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Jane Hankins, MD, MS
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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