Observational Study of Iron Overload in Stem Cell Transplantation

Dana-Farber Cancer Institute

Status: Completed

Conditions: Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT00954720

07-413

Details and patient eligibility

About

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.

Full description

As above.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

Patient undergoing transplant

Description:

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

Treatment:

Other: No Intervention