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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


N/A
18 Years
N/A
Open (Enrolling)
Both
MDS and AML Prior to Allogeneic SCT

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Trial Information

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


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)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome 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)

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Martin Wemke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

on behalf of GWT

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ALLIVE-2012

NCT ID:

NCT01746147

Start Date:

December 2012

Completion Date:

August 2015

Related Keywords:

  • MDS and AML Prior to Allogeneic SCT
  • MDS
  • AML
  • allogeneic SCT
  • Myelodysplastic Syndromes
  • Preleukemia

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