A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States
Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after
administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be
associated with satisfactory engraftment and acceptable post-transplant non-relapse
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).
United States: Institutional Review Board
|University Medical Center and UMC-North Clinic||Tucson, Arizona 85719|