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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

NCT ID: NCT01746147

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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MDS and AML Prior to Allogeneic SCT

Keywords

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MDS AML allogeneic SCT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MDS and AML prior to allogeneic SCT

No intervention and study treatment

Intervention Type OTHER

Interventions

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No intervention and study treatment

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GWT-TUD GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Wemke, MD

Role: PRINCIPAL_INVESTIGATOR

on behalf of GWT

Locations

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III. Medizinischen Klinik Hämatologie und Internistische Onkologie Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Site Status

III. Medizinischen Klinik des Klinikums rechts der Isar

München, Bavaria, Germany

Site Status

Universitätsklinikum MKII, Hämatologie/Onkologie, Universitäres Zentrum für Tumorerkrankungen

Frankfurt am Main, Hesse, Germany

Site Status

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

Bonn, North Rhine-Westphalia, Germany

Site Status

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

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29628397 (View on PubMed)

Other Identifiers

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ALLIVE-2012

Identifier Type: -

Identifier Source: org_study_id