Iron Overload in Patients Undergoing Donor Stem Cell Transplant

University of Minnesota (UMN)

Status: Completed

Conditions: Allogeneic Hematopoietic Cell Transplantation; Hematopoietic Stem Cell Transplantation; Cancer

Treatments: Procedure: Serum ferritin; Procedure: magnetic resonance imaging

Study type: Observational

Funder types: Other

Identifiers

NCT00888316

0807M41481 (Other Identifier)

2008NTLS103

CICL670AUS28T (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

112 participants in 2 patient groups

Without Iron Overload

Description:

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.

Treatment:

Procedure: Serum ferritin

Procedure: magnetic resonance imaging

With Iron-Overload

Description:

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.

Treatment:

Procedure: Serum ferritin

Procedure: magnetic resonance imaging