NCT00965224

Efficacy of Dendritic Cell Therapy for Myeloid Leukemia and Myeloma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Zwi Berneman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	dendritic cell vaccination (active specific immunotherapy)

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-12-01
• Completion: 2019-03-07
• First posted: 2009-08-25
• Last updated: 2024-12-13

Locations

1 site across 1 country: Belgium