NCT00888316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

3.5 years

First QC Date

April 24, 2009

Last Update Submit

November 29, 2017

Conditions

CancerHematopoietic Stem Cell TransplantationAllogeneic Hematopoietic Cell Transplantation

Keywords

iron overload

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Number of patients alive at 1 year.

    1 Year

Secondary Outcomes (7)

  • Incidence of non-relapse mortality

    Up to 1 Year

  • Acute and chronic graft-vs-host disease

    1 Year Post Transplant

  • Overall survival and non-relapse mortality

    1 Year Post Transplant

  • Number of Patients with Iron Overload

    Baseline

  • Ferritin levels and Liver Iron Concentration

    Baseline, and 3, 6, 9, and 12 Months Post Transplant

  • +2 more secondary outcomes

Study Arms (2)

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 imagingProcedure: Serum ferritin

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 imagingProcedure: Serum ferritin

Interventions

magnetic resonance imagingPROCEDURE

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.

Also known as: R2 MRI
With Iron-OverloadWithout Iron Overload
Serum ferritinPROCEDURE

Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant

With Iron-OverloadWithout Iron Overload

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Allogeneic Hematopoietic Cell Transplantation

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Children's Hospital - Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

NeoplasmsIron Overload

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Linda Burns, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

December 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

US(1)