45
Participants
Start Date
December 17, 2015
Primary Completion Date
December 30, 2027
Study Completion Date
December 30, 2028
Alemtuzumab
Transplant Conditioning Drug: Monoclonal antibody that targets recipient and donor T-cells to prevent graft verses host disease. Not an IND. This is a well studied drug, and is not under an IND.
Busulfan
Transplant Conditioning Drug: Chemotherapy to create space in the patient's bone marrow so that the donor peripheral blood stem cells can repopulate in the patient's bone marrow. This is a well studied drug, and is not under an IND.
Sirolimus
Immunosuppressant to prevent donor peripheral blood stem cell rejection and graft versus host disease. This is a well studied drug, and is not under an IND.
Cyclophosphamide
Post transplant cyclophosphamide given to prevent graft verses host disease. This is a well studied drug, and is not under an IND.
Total Body Irradiation
Transplant Conditioning Total Body Radiation (300cGy in 2 fractionated doses), given only to patient receiving matched unrelated donor cells, to create space in the patient's bone marrow so that the donor peripheral blood stem cells can repopulate in the patient's bone marrow.
Peripheral blood stem cells
Donor Peripheral blood stem cells, either matched unrelated donor or matched related relative to replace the patient's immune cells with functional immune cells. The peripheral blood stem cells are not regulated by the FDA.
National Institutes of Health Clinical Center, Bethesda
National Institute of Allergy and Infectious Diseases (NIAID)
NIH