NCT00954720

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

August 5, 2009

Last Update Submit

February 26, 2013

Conditions

Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic Syndrome

Keywords

AMLALLMDSiron overload

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Patient undergoing transplant

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

Other: No Intervention

Interventions

No InterventionOTHER

There is no intervention on this trial

Patient undergoing transplant

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient's who are 18 years or older with acute leukema or MDS underdoing a myeloablative allogeneic stem cell transplant

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Banked serum and mononuclear cells

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesIron Overload

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Philippe Armand, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

March 1, 2008

Primary Completion

January 1, 2011

Study Completion

May 1, 2011

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)