CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
dendritic cell vaccination (active specific immunotherapy)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00965224
NCT00965224Phase 2Completed

Therapeutic Efficacy of Wilms Tumor Gene (WT1) MRNA-electroporated Autologous Dendritic Cell Vaccination in Patients with Myeloid Malignancies and Multiple Myeloma: a Phase II Trial

Zwi Berneman·interventional·Posted Aug 25, 2009·Updated Dec 13, 2024

In Brief

A Phase 2 clinical trial evaluating dendritic cell vaccination (active specific immunotherapy) for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Dendritic cell therapy is a promising strategy for adjuvant cancer therapy in the setting of minimal residual disease (MRD) to fight off cancer relapse and/or progression. The investigators already performed a phase I safety study in leukemia patients that were in complete remission demonstrating the absence of side effects and feasibility of the therapy. Here, the investigators want to extend on this strategy by studying the clinical efficacy of autologous DC vaccination in patients with acute and chronic myeloid leukemia and myeloma patients. Effects of DC therapy on the immune reactivity towards leukemia cells as well as clinical parameters such molecular MRD monitoring, time to relapse (TTR), progression-free survival (PFS) and overall survival(OS) will be studied in vaccinated and non-vaccinated (control) patients. Patients will be vaccinated using their own dendritic cells electroporated with mRNA coding for the full-length Wilms' tumor antigen WT1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2014
Study CompletionMar 7, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.9 years ago

Interventions

dendritic cell vaccination (active specific immunotherapy)biological