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

NCT01746147 | Completed

• 1 other identifier: ALLIVE-2012
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 5

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).

Conditions

MDS and AML Prior to Allogeneic SCT

Keywords

MDS; AML; allogeneic SCT

Outcome Measures

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)

  one year

Secondary Outcomes (10)

• • 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

  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

Study Arms (1)

Patients with MDS and AML prior to allogeneic SCT

Other: No intervention and study treatment

Interventions

No intervention and study treatment OTHER

Patients with MDS and AML prior to allogeneic SCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women with AML or MDS according to WHO classification.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (5)

III. Medizinischen Klinik Hämatologie und Internistische Onkologie Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

III. Medizinischen Klinik des Klinikums rechts der Isar

München, Bavaria, 81675, Germany

Location

Universitätsklinikum MKII, Hämatologie/Onkologie, Universitäres Zentrum für Tumorerkrankungen

Frankfurt am Main, Hesse, 60590, Germany

Location

Medizinische Klinik und Poliklinik III Abteilung für Hämatologie und Onkologie Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitätsklinikum Carl Gustav Carus der TU Dresden Medizinische Klinik und Poliklinik I

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• 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.

  PMID: 29628397 DERIVED

MeSH Terms

Interventions

Pharmaceutical Preparations

Study Officials

• Martin Wemke, MD

  on behalf of GWT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 10, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

DE (5)