Busulfan and Melphalan With Autologous Hematopoietic Stem Cell Support With Positively-Selected CD133+ Hematopoietic Cells for Children With High Risk Solid Tumors and Lymphomas
Secondary objectives for this protocol include the following:
- To describe CD133+ graft content post-selection and to describe the yield and purity of
CD133+ content of the graft obtained.
- To describe the negative selection efficiency of this strategy by assessing the
processed product for tumor specific markers, when applicable.
- To characterize the proliferation of clonal progeny of CD133+ cells.
- To characterize lymphocyte and hematopoietic reconstitution (including the kinetics of
platelet engraftment) in these patients.
- To estimate one-year disease-free and overall survival in these transplant recipients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of the treatment plan using Busulfan and Melphalan followed by infusion of CD133+ selected hematopoietic cells in patients with high-risk malignancies.
August 2005
Yes
Gregory Hale, M.D.
Principal Investigator
St. Jude Children's Research Hospital
United States: Food and Drug Administration
ST133
NCT00152126
August 2003
February 2009
Name | Location |
---|---|
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |