Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1
I. Determine the safety of total body irradiation and post-transplant cyclosporine and mycophenolate mofetil in high-risk patients with human immunodeficiency virus-1.
II. Determine whether this regimen results in stable mixed donor lymphocyte chimerism (5-95% donor CD3) in this patient population.
III. Determine the kinetics of immune reconstruction following this treatment regimen in this patient population.
IV. Determine the effect of this treatment regimen on viral load in this patient population.
Drug: Mycophenolate mofetil
Procedure: Total body irradiation and stem cell or bone marrow transplantation
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Mortality due to infection, donor chimerism [ Time Frame: Days 14, 28, 56, 80, 180, and 360 ] [ Designated as safety issue: Yes ]
- CD4, viral load [ Time Frame: Days 14, 28, 56, 80, 180, and 360 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2000|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Participants will receive a stem cell transplantation along with a non-marrow ablative conditioning regimen containing total bdoy irradiation combined with post-transplant immunosuppression with cyclosporine and mycophenolate mofetil
Oral or IV cyclosporine 2 to 3 times daily on Days -1 to 50Drug: Mycophenolate mofetil
Beginning within 6 hours of transplantation, oral mycophenolate mofetil every 12 hours until Day 27.Procedure: Total body irradiation and stem cell or bone marrow transplantation
Assuming donor is available, total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0.
Patients receive oral or IV cyclosporine 2-3 times daily on Days -1 to 50. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation on Day 0 (assuming donor is available). Beginning within 6 hours of transplantation, patients receive oral mycophenolate mofetil every 12 hours until Day 27.
Patients with an unstable level of chimerism may receive 1-2 donor lymphocyte infusions.
Patients are followed at Days 14, 28, 56, 80, 180, and 360.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010348
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ann Woolfrey 206-667-4453|
|Study Chair:||Ann Woolfrey||Fred Hutchinson Cancer Research Center|