Clinical trial · Observational
Observational Study of Iron Overload in Stem Cell Transplantation
A Prospective Observational Study of Iron Overload in Patients With Acute Leukemia or Myelodysplastic Syndromes Undergoing Myeloablative Allogeneic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient undergoing transplant
- description
- Patients with acute leukemia or MDS undergoing ablative stem cell transplantation. No intervention.
- interventionNames
- Other: No Intervention
Primary outcomes (1)
- measure
- 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)
- timeFrame
- Pre-transplant
Secondary outcomes (2)
- measure
- 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.
- timeFrame
- 1 year post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available