Observational Study of Iron Overload in Stem Cell Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00954720
First received: August 5, 2009
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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 ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Banked serum and mononuclear cells


Enrollment: 45
Study Start Date: March 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

As above.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Philippe Armand, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00954720     History of Changes
Other Study ID Numbers: 07-413
Study First Received: August 5, 2009
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
AML
ALL
MDS
iron overload

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

ClinicalTrials.gov processed this record on September 22, 2014