Iron Overload in Patients Undergoing Donor Stem Cell Transplant
Condition: Cancer; Hematopoietic Stem Cell Transplantation; Allogeneic Hematopoietic Cell Transplantation
MeSH terms: Iron Overload
Study type: Observational

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.
    

Intervention name(s): magnetic resonance imaging; Serum ferritin
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Blood samples will be taken pre-transplant, 3, 6, 9 and 12 months post-transplant
Other intervention name(s): R2 MRI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Allogeneic Hematopoietic Cell Transplantation
      
Keywords: iron overload