drugset / Trial / NCT00514189
Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Primary Objectives: 1. To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy. 2. To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA. 3. To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA. Secondary Objectives: 1. To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene. 2. To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.
Timeline
- Start
- 2007-07
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous dendritic cells | Cell therapy | — | Other |