Iron Overload in Patients Undergoing Donor Stem Cell Transplant
- Conditions
- Hematopoietic Stem Cell TransplantationCancerAllogeneic Hematopoietic Cell Transplantation
- Interventions
- Procedure: magnetic resonance imagingProcedure: Serum ferritin
- Registration Number
- NCT00888316
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
-
Planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning
- 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.
- Claustrophobia
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description With Iron-Overload Serum ferritin 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. Without Iron Overload Serum ferritin 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. Without Iron Overload magnetic resonance imaging 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. With Iron-Overload magnetic resonance imaging 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.
- Primary Outcome Measures
Name Time Method Overall Survival 1 Year Number of patients alive at 1 year.
- Secondary Outcome Measures
Name Time Method Ferritin levels and Liver Iron Concentration Baseline, and 3, 6, 9, and 12 Months Post Transplant 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)
Number of Patients with Iron Overload Baseline Prevalence of iron overload in patients being considered for allogeneic HSCT
Incidence of non-relapse mortality Up to 1 Year Number of patients who died due to serious infections, hepatic venous occlusive disorder (VOD) or organ failure within one year of transplant.
Acute and chronic graft-vs-host disease 1 Year Post Transplant Number of patients who had acute and chronic graft versus host disease through 1 year after transplant.
Longitudinal averages of serum ferritin levels Post Transplant Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.
Overall survival and non-relapse mortality 1 Year Post Transplant 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.Incidence of iron overload 1 Year Post Transplant Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.
Trial Locations
- Locations (1)
University of Minnesota Children's Hospital - Fairview
🇺🇸Minneapolis, Minnesota, United States