Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01686334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2012-07-26
Brief Title:
Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission
Sponsor:
Zwi Berneman
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Wilms Tumor WT1 Antigen-targeted Dendritic Cell Vaccination to Prevent Relapse in Adult Patients With Acute Myeloid Leukemia a Multicenter Randomized Phase II Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WIDEA
Brief Summary:
The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase III study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of acute myeloid leukemia AML patients by eradicating minimal residual disease
Detailed Description:
Together with the Transplant Committee of the Belgian Hematological Society BHS we will perform a multicenter randomized open-label phase II clinical study in 130 patients with acute myeloid leukemia AML Adult patients 18 years with AML who have entered morphological CR or CRi after 1 intensive chemotherapy ie i at least one cycle of induction and one cycle of consolidation chemotherapy or ii one to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment or 2 low-intensity chemotherapy ie iii at least two cycles to maximum six cycles of hypomethylating agents whether or not combined with venetoclax or iv at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax and fulfilling all other eligibility criteria will be randomized to be vaccinated with dendritic cells or to receive regular follow-up care After randomization patients receiving low-intensity chemotherapy are allowed to continue this treatment in combination with DC vaccination or the follow-up care The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase III 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 2013 and will last for 10 years or until 130 efficacy-evaluable AML patients are included In the interventional group 65 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 130 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 General and disease-specific quality of life will be evaluated using quality of life questionnaires at regular time points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None