NCT00888316

Iron Overload in Patients Undergoing Donor Stem Cell Transplant

Iron Overload in Allogeneic Hematopoietic Cell Transplantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cancer
• Hematopoietic Stem Cell Transplantation
• Allogeneic Hematopoietic Cell Transplantation

Interventions

Type	Name	Description
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.
PROCEDURE	Serum ferritin	Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-04-27
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States