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Observational Study of Iron Overload in Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954720
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, 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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Other: No Intervention

Detailed Description:
As above.

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation
Study Start Date : March 2008
Primary Completion Date : January 2011
Study Completion Date : May 2011

Group/Cohort Intervention/treatment
Patient undergoing transplant
Patients with acute leukemia or MDS undergoing ablative stem cell transplantation. No intervention.
Other: No Intervention
There is no intervention on this trial

Primary Outcome Measures :
  1. 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) [ Time Frame: Pre-transplant ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 year post-transplant ]
  2. 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. [ Time Frame: 6 month and 1 year ]

Biospecimen Retention:   Samples With DNA
Banked serum and mononuclear cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient's who are 18 years or older with acute leukema or MDS underdoing a myeloablative allogeneic stem cell transplant

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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954720

United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Principal Investigator: Philippe Armand, MD, PhD Dana-Farber Cancer Institute

Responsible Party: Philippe Armand, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00954720     History of Changes
Other Study ID Numbers: 07-413
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by Philippe Armand, MD, PhD, Dana-Farber Cancer Institute:
iron overload

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Iron Overload
Pathologic Processes
Neoplasms by Histologic Type
Leukemia, Myeloid
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iron Metabolism Disorders
Metabolic Diseases