Iron Overload in Patients Undergoing Donor Stem Cell Transplant
NCT ID: NCT00888316
Last Updated: 2017-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
112 participants
OBSERVATIONAL
2008-12-31
2012-06-30
Brief Summary
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PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.
Detailed Description
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Primary
* Determine the impact of pre-transplant iron overload (defined as liver iron concentration \[LIC\] above normal \[\> 1.8 mg/g\] on an MRI of the liver measuring tissue proton transverse relaxation rates \[R2 MRI\]) on the probability of 1-year overall survival of patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Secondary
* Determine the impact of pre-transplant iron overload on the composite endpoint of non-relapse mortality and complications (e.g., serious infections, hepatic veno-occlusive disease, or organ failure) within 1 year after allogeneic HSCT.
* Determine the impact of pre-transplant iron overload on the 1-year cumulative incidence of acute or chronic graft-vs-host disease in patients with acute leukemia or myelodysplastic syndromes undergoing allogeneic HSCT.
* Determine the impact of pre-transplant iron overload on the 1-year probability of overall survival and non-relapse mortality in patients undergoing allogeneic HSCT.
* Determine the prevalence of pre-transplant iron overload in adult patients undergoing allogeneic HSCT.
* Determine the correlation between pre-transplant ferritin levels and LIC on R2 MRI.
* Compare the longitudinal measures of serum ferritin levels after allogeneic HSCT in patients with iron overload vs those without iron overload.
* Estimate the cumulative incidence of iron overload at 1 year after allogeneic HSCT.
OUTLINE: Patients undergo blood sample collection to measure serum ferritin levels at baseline (pre-transplant) and then at 3, 6, 9, and 12 months after transplant. Patients with serum ferritin \> 500 ng/mL also undergo an R2 MRI at baseline (pre-transplant) and at 12 months after transplant to determine liver iron concentration. Patients with serum ferritin \> 500 ng/mL at 12 months after transplant also undergo an R2 MRI.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Without Iron Overload
Patients entering study without pre-HSCT iron-overload. Iron overload will be defined as liver ion concentration (LIC above normal (\>1.8 mg/g) on R2 magnetic resonance imaging (MRI) of the liver.
magnetic resonance imaging
MRI of the liver will be performed within 30 days prior to HSCT (day 0) and can be done during receipt of conditioning regimen chemotherapy and/or radiation therapy. MRI will also be performed in selected patients at 1 year post-HSCT. This MRI will be done within ± 30 days of their 1-year post-transplant followup date.
The R2 MRI is a specific MRI technique and cannot be used for the purpose of general diagnostic imaging. In our study, this modality is being used specifically for the estimation of LIC.
Serum ferritin
Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant
With Iron-Overload
Patients entering study with pre-HSCT iron-overload. Iron overload will be defined as liver ion concentration (LIC above normal (\>1.8 mg/g) on R2 magnetic resonance imaging (MRI) of the liver.
magnetic resonance imaging
MRI of the liver will be performed within 30 days prior to HSCT (day 0) and can be done during receipt of conditioning regimen chemotherapy and/or radiation therapy. MRI will also be performed in selected patients at 1 year post-HSCT. This MRI will be done within ± 30 days of their 1-year post-transplant followup date.
The R2 MRI is a specific MRI technique and cannot be used for the purpose of general diagnostic imaging. In our study, this modality is being used specifically for the estimation of LIC.
Serum ferritin
Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant
Interventions
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magnetic resonance imaging
MRI of the liver will be performed within 30 days prior to HSCT (day 0) and can be done during receipt of conditioning regimen chemotherapy and/or radiation therapy. MRI will also be performed in selected patients at 1 year post-HSCT. This MRI will be done within ± 30 days of their 1-year post-transplant followup date.
The R2 MRI is a specific MRI technique and cannot be used for the purpose of general diagnostic imaging. In our study, this modality is being used specifically for the estimation of LIC.
Serum ferritin
Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any diagnosis allowed
* Not pregnant
* Weight ≤ 350 lbs
* Must be able to give written informed consent indicating the investigational nature of the study and its potential risks.
Exclusion Criteria
* Other contraindication for MRI (e.g., cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, or implanted drug infusion device)
18 Years
75 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Linda Burns, M.D.
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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0807M41481
Identifier Type: OTHER
Identifier Source: secondary_id
CICL670AUS28T
Identifier Type: OTHER
Identifier Source: secondary_id
2008NTLS103
Identifier Type: -
Identifier Source: org_study_id