Last updated on February 2018

Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission


Brief description of study

The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease.

Detailed Study Description

Together with the Transplant Committee of the Belgian Hematological Society (BHS), we will perform a multicenter randomized open-label phase II clinical study in 138 patients with acute myeloid leukemia (AML). Adult patients (> 18 years) who are in complete hematological remission will be randomized to be vaccinated with dendritic cells or to receive regular follow-up care. The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of AML patients by eradicating minimal residual disease.

Patients will be recruited at 8 different centers in Belgium. Recruitment will start in the second half of 2013 and will last for 8 years or until 138 efficacy-evaluable AML patients are included. In the interventional group, 69 patients will be treated during two years with autologous dendritic cells loaded by messenger RNA electroporation with the Wilms' tumor antigen (WT1). The dendritic cell therapy product will be generated and generally administered in the coordinating center, which is the Antwerp University Hospital, more specifically the Center for Cell Therapy and Regenerative Medicine (CCRG) and the Division of Hematology, both headed by Prof. Zwi Berneman. After inclusion of 138 efficacy-evaluable patients, relapse rate, relapse-free survival and overall survival analysis will be performed. Tumor marker levels and immune activation will also be monitored to compare the 2 groups at a molecular and immunological level.

Clinical Study Identifier: NCT01686334

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Zwi N Berneman, MD, PhD

Antwerp University Hospital
Antwerp, Belgium
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Local Investigator: Rik Schots, MD, ...

University Hospital Brussels
Brussels, Belgium
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Local Investigator: Violaine Havelange , ...

Cliniques Universitaires Saint-Luc
Brussel, Belgium
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Local Investigator: Tessa Kerre , ...

Ghent University Hospital
Ghent, Belgium
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Local Investigator: Yves Beguin , ...

Centre Hospitalier Universitaire de Li ge
Liège, Belgium
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Recruitment Status: Open


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