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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 (ALLIVE)

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ClinicalTrials.gov Identifier: NCT01746147
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
MDS and AML Prior to Allogeneic SCT Other: No intervention and study treatment

Study Design
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Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Study Start Date : December 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with MDS and AML prior to allogeneic SCT Other: No intervention and study treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. • Correlation coefficient of Liver iron concentration (LIC) and duration of detectable LPI during and after conditioning [ Time Frame: one year ]
  2. • 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 [ Time Frame: one year ]
  3. • Association of serum ferritin and LIC with hematopoietic cell transplantation comorbidity index (HCT-CI) [ Time Frame: one year ]
  4. • Time course of LPI, enhanced labile plasma iron (eLPI), directly chelatable iron (DCI) and hepcidin during allo-SCT [ Time Frame: one year ]
  5. • Association of detectable LPI or eLPI during conditioning and occurrence of elevated liver enzymes during in hospital treatment course for allo-SCT [ Time Frame: one year ]
  6. • 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 [ Time Frame: one year ]
  7. • 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 [ Time Frame: one year ]
  8. • 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 [ Time Frame: one year ]
  9. • Median change of serum ferritin and LIC 100 days and 1 year after allo-SCT [ Time Frame: one year ]
  10. • 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 [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women with AML or MDS according to WHO classification.
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746147


Locations
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Germany
III. Medizinischen Klinik Hämatologie und Internistische Onkologie Universitätsmedizin Mannheim
Mannheim, Baden-Württemberg, Germany, 68167
III. Medizinischen Klinik des Klinikums rechts der Isar
München, Bayern, Germany, 81675
Universitätsklinikum MKII, Hämatologie/Onkologie, Universitäres Zentrum für Tumorerkrankungen
Frankfurt, Hessen, Germany, 60590
Medizinische Klinik und Poliklinik III Abteilung für Hämatologie und Onkologie Universitätsklinikum Bonn
Bonn, Nordrhein-Westfalen, Germany, 53127
Universitätsklinikum Carl Gustav Carus der TU Dresden Medizinische Klinik und Poliklinik I
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
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Principal Investigator: Martin Wemke, MD on behalf of GWT
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01746147    
Other Study ID Numbers: ALLIVE-2012
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Keywords provided by GWT-TUD GmbH:
MDS
AML
allogeneic SCT