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Brief Title: Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission
Official Title: Wilms Tumor Gene (WT1) mRNA-transfected Autologous Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia (AML): a Phase I Trial
Study ID: NCT00834002
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Antwerp University Hospital/Center for Cellular Therapy and Regenerative Medicine, Edegem, , Belgium
Name: Zwi Berneman, MD, PHD
Affiliation: University Hospital, Antwerp
Role: STUDY_DIRECTOR
Name: Ann Van de Velde, MD
Affiliation: University Hospital, Antwerp
Role: PRINCIPAL_INVESTIGATOR
Name: Viggo FI Van Tendeloo, PhD
Affiliation: University Hospital, Antwerp
Role: PRINCIPAL_INVESTIGATOR