NCT00834002

Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission

Wilms Tumor Gene (WT1) mRNA-transfected Autologous Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia (AML): a Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from a patient's white blood cells (dendritic cells) and a specific leukemia antigen (Wilms tumor antigen-1) may induce an effective immune response to kill residual leukemic cells and/or prevent leukemia relapse. PURPOSE: This phase I/II trial is studying the feasibility, safety and efficacy of intradermal mRNA-transfected dendritic cell vaccination therapy in patients with acute myeloid leukemia.

Detailed description

Autologous dendritic cell (DC) vaccination is a promising strategy for adjuvant cancer therapy in the setting of minimal residual disease (MRD). We performed a phase I/II trial in patients with acute myeloid leukemia (AML) where patients received intradermal injections of autologous DC loaded with mRNA coding for the Wilms' tumor protein (WT1). WT1 is highly overexpressed in leukemia and the level of WT1 RNA in peripheral blood is a useful biomarker for molecular diagnosis en follow-up in the MRD setting. We want to prospectively monitor WT1 RNA expression in the peripheral blood of vaccinated and non-vaccinated AML patients in order to evaluate its predictive value as a biomarker for relapse and to assess the clinical efficacy of DC vaccination in acute myeloid leukemia patients. We believe, on the basis of already available evidence, that the use of WT1 both as a target for immunotherapy as well as a biomarker not holds promise to assess the efficacy of new experimental therapeutic interventions such as DC vaccination.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
BIOLOGICAL	injection of antigen-loaded cultured dendritic cells	intradermal injection of WT1-RNA-electroporated autologous dendritic cell vaccine (therapeutic cell vaccine)

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-11-01
• Completion: 2008-12-01
• First posted: 2009-02-02
• Last updated: 2010-02-09

Locations

1 site across 1 country: Belgium