Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
|ClinicalTrials.gov Identifier: NCT00514189|
Recruitment Status : Terminated (Terminated early due to slow accrual.)
First Posted : August 9, 2007
Last Update Posted : July 30, 2012
- 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.
- To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.
- To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA.
- To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene.
- To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: Autologous Dendritic Cells||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: Autologous Dendritic Cells||
Biological: Autologous Dendritic Cells
The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days).
Other Name: DCs
- Time to Adverse Event (AE) [ Time Frame: Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514189
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chitra M. Hosing, MD||M.D. Anderson Cancer Center|