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A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation


N/A
18 Years
65 Years
Not Enrolling
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

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Trial Information

A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation


As above.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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)

Outcome Time Frame:

Pre-transplant

Safety Issue:

No

Principal Investigator

Philippe Armand, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

07-413

NCT ID:

NCT00954720

Start Date:

March 2008

Completion Date:

May 2011

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • AML
  • ALL
  • MDS
  • iron overload
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Iron Overload

Name

Location

Dana Farber Cancer InstituteBoston, Massachusetts  02115