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

This study is currently recruiting participants.
Verified December 2012 by GWT-TUD GmbH
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01746147
First received: December 5, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention
MDS and AML Prior to Allogeneic SCT
Other: No intervention and study treatment

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Correlation coefficient of Liver iron concentration (LIC) and duration of detectable LPI during and after conditioning [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • Association of serum ferritin and LIC with hematopoietic cell transplantation comorbidity index (HCT-CI) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • Time course of LPI, enhanced labile plasma iron (eLPI), directly chelatable iron (DCI) and hepcidin during allo-SCT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • Median change of serum ferritin and LIC 100 days and 1 year after allo-SCT [ Time Frame: one year ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with MDS and AML prior to allogeneic SCT Other: No intervention and study treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746147

Contacts
Contact: Claudia Spielau, Dr. 0351 25933 123 Claudia.Spielau@gwtonline.de

Locations
Germany
III. Medizinischen Klinik Hämatologie und Internistische Onkologie Universitätsmedizin Mannheim Not yet recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Stefan Klein, Dr.    0621 - 383-4116    heike.weiss@umm.de   
III. Medizinischen Klinik des Klinikums rechts der Isar Not yet recruiting
München, Bayern, Germany, 81675
Contact: Katharina Götze, Dr.    089 - 4140-5618    k.goetze@lrz.tu-muenchen.de   
Medizinische Klinik und Poliklinik III Abteilung für Hämatologie und Onkologie Universitätsklinikum Bonn Not yet recruiting
Bonn, Nordrhein-Westfalen, Germany, 53127
Contact: Dominik Wolf, Prof. Dr.    0228 287 17233    dominik.wolf@ukb.uni-bonn.de   
Universitätsklinikum Carl Gustav Carus der TU Dresden Medizinische Klinik und Poliklinik I Recruiting
Dresden, Saxony, Germany, 01307
Contact: Martin Wermke, Dr    0351 458-15624    Martin.Wermke@uniklinikum-dresden.de   
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
Principal Investigator: Martin Wemke, MD on behalf of GWT
  More Information

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01746147     History of Changes
Other Study ID Numbers: ALLIVE-2012
Study First Received: December 5, 2012
Last Updated: December 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GWT-TUD GmbH:
MDS
AML
allogeneic SCT

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014