Iron Overload in Patients Undergoing Donor Stem Cell Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00888316
First received: April 24, 2009
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Cell Transplantation
Procedure: magnetic resonance imaging
Procedure: Serum ferritin
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iron Overload in Allogeneic Hematopoietic Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Number of patients alive at 1 year.


Secondary Outcome Measures:
  • Incidence of non-relapse mortality [ Time Frame: Up to 1 Year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 Year Post Transplant ] [ Designated as safety issue: No ]
    Number of patients who had acute and chronic graft versus host disease through 1 year after transplant.

  • Overall survival and non-relapse mortality [ Time Frame: 1 Year Post Transplant ] [ Designated as safety issue: No ]

    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.


  • Number of Patients with Iron Overload [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Prevalence of iron overload in patients being considered for allogeneic HSCT

  • Ferritin levels and Liver Iron Concentration [ Time Frame: Baseline, and 3, 6, 9, and 12 Months Post Transplant ] [ Designated as safety issue: No ]
    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)

  • Longitudinal averages of serum ferritin levels [ Time Frame: Post Transplant ] [ Designated as safety issue: No ]
    Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.

  • Incidence of iron overload [ Time Frame: 1 Year Post Transplant ] [ Designated as safety issue: No ]
    Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.


Enrollment: 112
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: 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.

Other Name: R2 MRI
Procedure: 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.
Procedure: 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.

Other Name: R2 MRI
Procedure: Serum ferritin
Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Allogeneic Hematopoietic Cell Transplantation

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888316

Locations
United States, Minnesota
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Linda Burns, M.D. Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00888316     History of Changes
Other Study ID Numbers: 2008NTLS103, 0807M41481, CICL670AUS28T
Study First Received: April 24, 2009
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
iron overload

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014