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| ID | Type | Description | Link |
|---|---|---|---|
| 0807M41481 | Other Identifier | IRB, University of Minnesota | |
| CICL670AUS28T | Other Identifier | Novartis Pharmaceuticals |
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RATIONALE: Learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment.
PURPOSE: This study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of patients alive at 1 year. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-relapse mortality | Number of patients who died due to serious infections, hepatic venous occlusive disorder (VOD) or organ failure within one year of transplant. | Up to 1 Year |
| Acute and chronic graft-vs-host disease |
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Inclusion Criteria:
Planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning
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:
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Allogeneic Hematopoietic Cell Transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Linda Burns, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Children's Hospital - Fairview | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019190 | Iron Overload |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Serum ferritin | Procedure | Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant |
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Number of patients who had acute and chronic graft versus host disease through 1 year after transplant.
| 1 Year Post Transplant |
| Overall survival and non-relapse mortality | Number of patients who were alive and did not have any non-relapse mortality events at 1 year post transplant. Determine the impact of pre-transplant iron-overload on 1-year probability of overall survival and of non-relapse mortality in allogeneic HSCT recipients with acute leukemia and myelodysplastic syndrome. | 1 Year Post Transplant |
| Number of Patients with Iron Overload | Prevalence of iron overload in patients being considered for allogeneic HSCT | Baseline |
| Ferritin levels and Liver Iron Concentration | Correlation between pre-transplant and post-transplant ferritin levels and liver iron concentration on an MRI of the liver measuring tissue proton transverse relaxation rates (R2 MRI) | Baseline, and 3, 6, 9, and 12 Months Post Transplant |
| Longitudinal averages of serum ferritin levels | Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups. | Post Transplant |
| Incidence of iron overload | Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups. | 1 Year Post Transplant |