Iron Overload in Patients Undergoing Donor Stem Cell Transplant

Cancer Clinical Trial

Official title:

Iron Overload in Allogeneic Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888316
• Other study ID #: 2008NTLS103
• Secondary ID: 0807M41481CICL67
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: November 29, 2017
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: November 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota Children's Hospital - Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Number of patients alive at 1 year.	1 Year
Secondary	Incidence of non-relapse mortality	Number of patients who died due to serious infections, hepatic venous occlusive disorder (VOD) or organ failure within one year of transplant.	Up to 1 Year
Secondary	Acute and chronic graft-vs-host disease	Number of patients who had acute and chronic graft versus host disease through 1 year after transplant.	1 Year Post Transplant
Secondary	Overall survival and non-relapse mortality	Number of patients who were alive and did not have any non-relapse mortality events at 1 year post transplant.; Determine the impact of pre-transplant iron-overload on 1-year probability of overall survival and of non-relapse mortality in allogeneic HSCT recipients with acute leukemia and myelodysplastic syndrome.	1 Year Post Transplant
Secondary	Number of Patients with Iron Overload	Prevalence of iron overload in patients being considered for allogeneic HSCT	Baseline
Secondary	Ferritin levels and Liver Iron Concentration	Correlation between pre-transplant and post-transplant ferritin levels and liver iron concentration on an MRI of the liver measuring tissue proton transverse relaxation rates (R2 MRI)	Baseline, and 3, 6, 9, and 12 Months Post Transplant
Secondary	Longitudinal averages of serum ferritin levels	Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.	Post Transplant
Secondary	Incidence of iron overload	Compare the longitudinal measures of serum ferritin between the no iron-overload and iron-overload groups.	1 Year Post Transplant