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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MDS and AML prior to allogeneic SCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention and study treatment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| • Correlation coefficient of Liver iron concentration (LIC) and duration of detectable LPI during and after conditioning | one year | |
| • 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Men and women with AML or MDS according to WHO classification.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Wemke, MD | on behalf of GWT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| III. Medizinischen Klinik Hämatologie und Internistische Onkologie Universitätsmedizin Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29628397 | Derived | Wermke 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. |
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| one year |
| • Association of serum ferritin and LIC with hematopoietic cell transplantation comorbidity index (HCT-CI) | one year |
| • Time course of LPI, enhanced labile plasma iron (eLPI), directly chelatable iron (DCI) and hepcidin during allo-SCT | one year |
| • Association of detectable LPI or eLPI during conditioning and occurrence of elevated liver enzymes during in hospital treatment course for allo-SCT | one year |
| • Cumulative incidence of graft versus host disease (aGvHD) grade 2-4 with respect to serum ferritin >1000 µg/l, transfusion burden >20 units of Red blood cells (RBC), LIC >125 µmol/g, peak value and duration of detectable labile plasma iron above median | one year |
| • Cumulative incidence of day 100 non-relapse mortality (NRM) with respect to serum ferritin >1000 µg/l, transfusion burden >20 units of RBC, LIC >125 µmol/g and peak value and duration of detectable labile plasma iron above median | one year |
| • Cumulative incidence of infections with respect to serum ferritin >1000 µg/l, transfusion burden >20 parasitized red blood cell (PRBC), LIC >125 µmol/g and peak value and duration of detectable labile plasma iron above median | one year |
| • Median change of serum ferritin and LIC 100 days and 1 year after allo-SCT | one year |
| • Association between immune profile and iron parameters (serum ferritin >1000 µg/l, transfusion burden >20 units RBC, LIC >90 µmol/g and peak value and duration of detectable labile plasma iron above median | one year |
| III. Medizinischen Klinik des Klinikums rechts der Isar | München | Bavaria | 81675 | Germany |
| Universitätsklinikum MKII, Hämatologie/Onkologie, Universitäres Zentrum für Tumorerkrankungen | Frankfurt am Main | Hesse | 60590 | Germany |
| Medizinische Klinik und Poliklinik III Abteilung für Hämatologie und Onkologie Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitätsklinikum Carl Gustav Carus der TU Dresden Medizinische Klinik und Poliklinik I | Dresden | Saxony | 01307 | Germany |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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