Wilms' Tumor (WT1) Antigen-targeted Dendritic Cell Vaccination to Prevent Relapse in Patients Older Than 65 Years With Acute Myeloid Leukemia: a Multicenter Randomized Phase II Trial
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). Patients older than 65 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 2012 and will last for three 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse rate
The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on relapse rate in AML patients older than 65 years and in complete remission.
No
Zwi Berneman, MD, PhD
Principal Investigator
University Hospital, Antwerp
Belgium: Federal Agency for Medicinal Products and Health Products
CCRG12-001
NCT01686334
October 2012
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