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NCT Number: NCT01746147

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

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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Key information

Conditions

MDS and AML Prior to Allogeneic SCT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

III. Medizinischen Klinik Hämatologie und Internistische Onkologie Universitätsmedizin Mannheim, Mannheim, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention and study treatment

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Registry information

Official study 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

Acronym: ALLIVE

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Dec 10, 2012
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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