Trial Information

Iron Overload in Allogeneic Hematopoietic Cell Transplantation

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.