Clinical trial NCT00888316: Iron Overload in Patients Undergoing Donor Stem Cell Transplant
Official title: Iron Overload in Allogeneic Hematopoietic Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Cell Transplantation
Keywords: iron overload
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Allogeneic Hematopoietic Cell Transplantation

Brief 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.

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)

Primary outcomes:
measure: Overall Survival
timeFrame: 1 Year
Secondary outcomes:
measure: Incidence of non-relapse mortality
timeFrame: Up to 1 Year
measure: Acute and chronic graft-vs-host disease
timeFrame: 1 Year Post Transplant
measure: Overall survival and non-relapse mortality
timeFrame: 1 Year Post Transplant
measure: Number of Patients with Iron Overload
timeFrame: Baseline
measure: Ferritin levels and Liver Iron Concentration
timeFrame: Baseline, and 3, 6, 9, and 12 Months Post Transplant
measure: Longitudinal averages of serum ferritin levels
timeFrame: Post Transplant
measure: Incidence of iron overload
timeFrame: 1 Year Post Transplant
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Children's Hospital - Fairview
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Linda Burns, M.D.
role: PRINCIPAL_INVESTIGATOR
References: