Observational Study of Iron Overload in Stem Cell Transplantation

Completed

• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome
• Interventions: Other: No Intervention

• Registration Number: NCT00954720
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

Recent retrospective studies have suggested that iron overload is a clinically important problem in patients undergoing ablative stem cell transplantation. However, these studies relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that can be drawn from such analyses. Therefore, the investigators are conducting a prospective study to more rigorously examine the prevalence, mechanisms, and consequences of iron overload in this patient population.

Detailed Description

As above.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2011-01
• Study Completion: 2011-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Age ≥ 18 years.
• Histologically confirmed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS)
• Planned allogeneic stem cell transplantation with myeloablative conditioning regimen (regardless of stem cell source or donor HLA match)
• Patients will be eligible even if they have had prior stem cell transplantation (autologous or allogeneic)

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Exclusion Criteria

• Contraindication to magnetic resonance imaging (MRI):

  • Patients with cardiac pacemakers, implanted cardiac defibrillator (ICD), cardiac electrodes, pacing wires, internal electrodes, cochlear, otologic or other ear implants, metallic fragments or foreign body, metallic prosthesis. Patients with surgical staples should not be imaged until 7 days post-op unless approved by a radiologist;
  • Severe claustrophobia
  • Note: a history of allergic reaction to gadolinium is not a contraindication to enrollment, as contrast will not be used.

• Inability to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient undergoing transplant	No Intervention	Patients with acute leukemia or MDS undergoing ablative stem cell transplantation. No intervention.

Primary Outcome Measures

Name	Time	Method
To estimate the prevalence of pre-transplantation iron overload (defined as liver iron content >2 mg/g dry weight by MRI) and of pre-transplantation severe iron overload (defined as liver iron content >7 mg/g dry weight by MRI)	Pre-transplant

Secondary Outcome Measures

Name	Time	Method
To compare 6-month and 1-year TRM between patients with pre-transplantation serum ferritin > 2500 ng/ml and those with ferritin ≤ 2500 ng/ml.	6 month and 1 year
To estimate the 6-month and 12-month prevalence of iron overload determined by liver MRI • To compare 6-month and 1-year TRM between patients with severe pre-transplantation iron overload (>7 mg/g dry weight) and those without.	1 year post-transplant

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States