Clinical trial · Observational
Assessment of Body, Liver and Labile Plasma Iron and Their Association With Outcome and Immunological Recovery in Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Patients Undergoing Allogeneic Stem Cell Transplantation - ALLIVE (ALLogeneic Iron inVEstigators) Observational Trial
Assessment of Body, Liver and Labile Plasma Iron and Their Association With Outcome and Immunological Recovery in MDS or AML Patients Undergoing Allogeneic Stem Cell Transplantation - ALLIVE (ALLogeneic Iron inVEstigators) Observational Trial
- 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)
The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic change of LPI occurrence during conditioning and at identifying LPI-predictive peri-transplant parameters. Further points of interest are the improvement of systemic iron overload (SIO) diagnostics and the correlation of different SIO parameters with outcome after transplantation. The results of this trial will help to design prospective interventional studies addressing therapeutic options in patients at risk for SIO-associated toxicity during allogeneic stem-cell transplantation (allo-SCT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MDS and AML Prior to Allogeneic SCT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention and study treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with MDS and AML prior to allogeneic SCT
- interventionNames
- Other: No intervention and study treatment
Primary outcomes (1)
- measure
- Description of dynamic changes of LPI prior, during and after conditioning for allo-SCT using standard descriptive parameters (Mean or Median and appropriate confidence intervals)
- timeFrame
- one year
Secondary outcomes (10)
- measure
- • Correlation coefficient of Liver iron concentration (LIC) and duration of detectable LPI during and after conditioning
- timeFrame
- one year
- measure
- • Area under the Receiver-Operator-Characteristic (ROC) as well as sensitivity and specificity of specific thresholds of serum ferritin and transfusion history for prediction of LIC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years at the time of signing the informed consent form * Signed informed consent * Diagnosis of AML or MDS according to WHO classification * Planned allogeneic stem cell transplantation after reduced intensity or myeloablative conditioning from related or unrelated donors * At risk for iron toxicity as defined by ferritin \>500 ng/ml and/or history of more than 10 RBC transfusions prior to allo-SCT Exclusion Criteria: * Claustrophobia or other mental disorders making MRI imaging unbearable for the patient * Cardiac pacemakers, metal implants splinters or other contraindications for MRI * More than 1 Human leukocyte antigen (HLA) allele or antigen mismatch between donor and recipient * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study * Patients who are not likely to follow the trial protocol (lack of willingness to cooperate)
References
Publications (1)
- DERIVEDWermke M, Eckoldt J, Gotze KS, Klein SA, Bug G, de Wreede LC, Kramer M, Stolzel F, von Bonin M, Schetelig J, Laniado M, Plodeck V, Hofmann WK, Ehninger G, Bornhauser M, Wolf D, Theurl I, Platzbecker U. Enhanced labile plasma iron and outcome in acute myeloid leukaemia and myelodysplastic syndrome after allogeneic haemopoietic cell transplantation (ALLIVE): a prospective, multicentre, observational trial. Lancet Haematol. 2018 May;5(5):e201-e210. doi: 10.1016/S2352-3026(18)30036-X. Epub 2018 Apr 5. PMID 29628397