Phase I Study Of The Use Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Secondary objectives of this study include exploring the pharmacoeconomics of palifermin in
this particular patient population through an assessment of inpatient days, intravenous
nutrition, and analgesia requirements within 100 days post-transplantation. We will also
explore the research participants' rates of immune reconstitution, specifically T and
B-lymphocytes and NK cells, within the first year of HSCT.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose and describe the toxicity profile of palifermin in pediatric research participants with hematologic malignancies undergoing first HSCT.
Ashok Srinivasan, MD
St. Jude Children's Research Hospital
United States: Institutional Review Board
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