Myelodysplastic Syndrome Clinical Trial

Iron Overload in Patients Undergoing Donor Stem Cell Transplant

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.

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Full 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.

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Eligibility 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)

Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

112

Study ID:

NCT00888316

Recruitment Status:

Completed

Sponsor:

Masonic Cancer Center, University of Minnesota

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There is 1 Location for this study

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University of Minnesota Children's Hospital - Fairview
Minneapolis Minnesota, 55455, United States

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Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

112

Study ID:

NCT00888316

Recruitment Status:

Completed

Sponsor:


Masonic Cancer Center, University of Minnesota

How clear is this clinincal trial information?

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