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Observational Study of Iron Overload in Stem Cell Transplantation

NCT ID: NCT00954720

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-05-31

Brief Summary

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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

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As above.

Conditions

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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome

Keywords

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AML ALL MDS iron overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient undergoing transplant

Patients with acute leukemia or MDS undergoing ablative stem cell transplantation. No intervention.

No Intervention

Intervention Type OTHER

There is no intervention on this trial

Interventions

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No Intervention

There is no intervention on this trial

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Philippe Armand, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Armand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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07-413

Identifier Type: -

Identifier Source: org_study_id