Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
I. To determine the safety of treating high-risk HIV1-infected patients with 200 cGy TBI
plus post-transplant MMF/CSP.
II. To determine whether 200 cGy TBI plus post-transplant MMF/CSP results in stable mixed
donor lymphocyte chimerism (5-95% donor CD3) in high-risk human immunodeficiency virus
(HIV)-1 infected patients.
I. To define the kinetics of immune reconstitution following a non-lethal conditioning
regimen in HIV1-infected patients.
II. To determine the effect of a non-lethal conditioning regimen on viral load.
CONDITIONING REGIMEN: Patients receive fludarabine intravenously (IV) over 2 hours on days
-4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or
peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or orally (PO) 2 to 3 times daily on
days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of
graft-vs-host disease (GVHD). Beginning within 6 hours after transplantation, patients also
receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in
the absence of GVHD.
After completion of study treatment, patients are followed up for at least 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Death from regimen toxicity or opportunistic infection
Within the first 100 days
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|