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

This study is currently recruiting participants.

Verified by Dana-Farber Cancer Institute, August 2009

First Received: August 5, 2009 Last Updated: August 6, 2009 History of Changes

Sponsored by:	Dana-Farber Cancer Institute
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00954720

Purpose

The investigators retrospective analysis argues that iron overload is indeed a clinically important problem in this patient population. However, serum ferritin is an imperfect surrogate for iron overload. Therefore, the investigators propose a prospective study to more rigorously examine the prevalence, mechanisms, and consequences of iron overload in this patient population.

Condition	Intervention
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome	Other: No Intervention

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patient undergoing transplant	Other: No Intervention There is no intervention on this trial

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954720

Locations

United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mildred Pasek, RN 617-632-5515 mpasek@partners.org
Contact: Marie-Michele Sainvil 617-632-5626 msainvil@partners.org
Principal Investigator: Philippe Armand, MD, PhD

Sponsors and Collaborators

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana Farber Cancer Institute ( Philippe Armand MD, PhD )
Study ID Numbers:	07-413
Study First Received:	August 5, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00954720 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

AML
ALL
MDS
iron overload

Study placed in the following topic categories:

Leukemia, Lymphoid
Metabolic Diseases
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Iron Metabolism Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia

Lymphatic Diseases
Acute Myelocytic Leukemia
Preleukemia
Iron Overload
Lymphoproliferative Disorders
Bone Marrow Diseases
Iron
Metabolic Disorder
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Leukemia, Lymphoid
Metabolic Diseases
Disease
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Precancerous Conditions
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Iron Metabolism Disorders

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Iron Overload
Bone Marrow Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 11, 2009