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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00954720
Other study ID # 07-413
Secondary ID
Status Completed
Phase N/A
First received August 5, 2009
Last updated February 26, 2013
Start date March 2008
Est. completion date May 2011

Study information

Verified date February 2013
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

As above.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date May 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
No Intervention
There is no intervention on this trial

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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