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.
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.
Gregory Hale, M.D.
St. Jude Children's Research Hospital
United States: Food and Drug Administration
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