Acute Lymphocytic LeukemiaNCT01965171
Transfusional Iron Overload Among Leukemia Survivors
An observational study of Acute Lymphocytic Leukemia and Acute Myeloid Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2013to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read more
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.
Read the 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).
- Conditions
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia
- Keywords
- hematologic malignancy, iron overload, magnetic resonance imaging, childhood cancer survivors
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Hematologic Neoplasms, Iron Overload
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of iron overload
Iron overload will be measured by R2*MRI in the liver and T2* in the heart and is defined as R2*MRI value > 3 mg/g and/or T2* MRI <20ms.
Measured: On day of enrollment
Secondary outcomes (2)
Relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally-acquired iron overload
Fisher's Exact test will be performed to examine the relationship of organ dysfunction and iron overload. Then the logistic regression model will be built to evaluate the effect of the iron overload defined by R2* and T2* MRI on the risk of organ dysfunction, respectively, while controlling for the effects of craniospinal radiation and chemotherapeutic agents.
Measured: On day of enrollment
Association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron overload
Logistic regression model will be used to evaluate the association of iron overload status and the above four iron test measurements.
Measured: On day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study start18 Oct 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Jane Hankins, MD, MS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965171
- Sponsor's protocol ID
- TRIALS
- Status last verified
- May 2017
- First submitted
- 11 Oct 2013
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusional Iron Overload Among Leukemia Survivors
- ClinicalTrials.gov ID
- NCT01965171
- Acronym / sponsor ID
- TRIALS
- Conditions
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia
- Keywords
- hematologic malignancy, iron overload, magnetic resonance imaging, childhood cancer survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of iron overload
Time frame: On day of enrollment
Iron overload will be measured by R2*MRI in the liver and T2* in the heart and is defined as R2*MRI value > 3 mg/g and/or T2* MRI <20ms.
2 secondary outcomes
Relationship between hepatic, cardiac, and endocrine dysfunction and transfusionally-acquired iron overload
Time frame: On day of enrollment
Association between serum ferritin, transferrin saturation, non-transferrin-bound iron, and hepcidin measurements with R2* and T2* MRI-defined iron overload
Time frame: On day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Hankins, MD, MS principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphocytic Leukemia and Acute Myeloid Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of iron overload (time frame: On day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.