Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission (WIDEA)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Relapse rate [ Time Frame: At study completion, an average of 5 year ] [ Designated as safety issue: No ]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.
- Disease-free survival [ Time Frame: At study completion, an average of 5 year ] [ Designated as safety issue: No ]The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on disease-free survival in AML patients older than 65 years and in complete remission.
- Overall survival [ Time Frame: At study completion, an average of 5 year ] [ Designated as safety issue: No ]The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on overall survival in AML patients older than 65 years and in complete remission.
- Change in WT1 mRNA levels in peripheral blood [ Time Frame: Through study completion, at every vaccination during 2 years ] [ Designated as safety issue: No ]Efficacy assessment will also be performed on a molecular level. To this end, peripheral blood samples will be obtained from participants in both study groups (vaccine group and control group) and analyzed by qRT-PCR for WT1 expression, which is a promising molecular biomarker in AML.
- Immune activation [ Time Frame: After the 4th DC vaccine ] [ Designated as safety issue: No ]This study aims to examine the presence of leukemia-specific immune responses in AML patients in remission and to investigate whether they can be induced or increased in these patients by WT1 mRNA-electroporated DC vaccination.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
Experimental: DC vaccine
Vaccination with autologous WT1 mRNA-electroporated DCs plus follow-up care
Biological: DC vaccine
Autologous WT1 mRNA-electroporated DCs
No Intervention: Control arm
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686334
|Contact: Zwi N Berneman, MD, PhD||+32 3 email@example.com|
|Contact: Ann Van de Velde, MD||+32 3 firstname.lastname@example.org|
|Antwerp University Hospital||Recruiting|
|Antwerp, Belgium, 2650|
|Principal Investigator: Zwi N Berneman, MD, PhD|
|Principal Investigator:||Zwi Berneman, MD, PhD||University Hospital, Antwerp|
|Principal Investigator:||Evelien LJ Smits, PhD||Universiteit Antwerpen|
|Principal Investigator:||Sébastien Anguille, MD||University Hospital, Antwerp|
|Principal Investigator:||Ann Van de Velde, MD||University Hospital, Antwerp|