Multicenter randomized phase II trial of Wilms' tumor (WT1) antigen-targeted dendritic cell vaccination to prevent relapse in patients with acute myeloid leukemia.

The five-year survival rate for acute myeloid leukemia (AML) is 26.6%, pointing to the need for new treatment options. We have recently provided the first clinical proof-of-concept evidence that vaccination with Wilms’ tumor 1 mRNA-electroporated dendritic cells (DC) can result in complete clearance of minimal residual disease. Our phase I/II study showed improved survival compared to historical data and demonstrable antileukemic effects. Now we want to confirm the results of our initial study in a multicenter randomized phase II clinical study in 138 patients with AML at high risk of relapse. The primary aim is to determine whether DC vaccination can significantly prevent relapse and increase survival. In addition, tumor marker levels and immune activation will be monitored. If the curative potential with low toxicity can be confirmed in this novel large randomized trial, our cell therapy can become a new standard postremission treatment for AML.

Keywords:WILMS TUMOR, ACUTE MYELOID LEUKEMIA

Disciplines:Systems biology, Hematology, Laboratory medicine