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Iron Overload in Allogeneic Hematopoietic Cell Transplantation


Phase 1
18 Years
75 Years
Not Enrolling
Both
Cancer, Hematopoietic Stem Cell Transplantation, Allogeneic Hematopoietic Cell Transplantation

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Trial Information

Iron Overload in Allogeneic Hematopoietic Cell Transplantation


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Overall Survival

Outcome Description:

Number of patients alive at 1 year.

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Linda Burns, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2008NTLS103

NCT ID:

NCT00888316

Start Date:

December 2008

Completion Date:

June 2012

Related Keywords:

  • Cancer
  • Hematopoietic Stem Cell Transplantation
  • Allogeneic Hematopoietic Cell Transplantation
  • iron overload
  • Iron Overload

Name

Location

University of Minnesota Children's Hospital - FairviewMinneapolis, Minnesota  55455