Status:

COMPLETED

Observational Study of Iron Overload in Stem Cell Transplantation

Lead Sponsor:

Dana-Farber Cancer Institute

Conditions:

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Eligibility:

All Genders

18-65 years

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 ferri...

Detailed Description

As above.

Eligibility Criteria

Inclusion

  • 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)

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2011

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00954720

Start Date

March 1 2008

End Date

May 1 2011

Last Update

February 28 2013

Active Locations (1)

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Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115