Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|