Reduced Intensity Myeloablative Total Body Irradiation and Thymoglobulin Followed by Allogeneic Peripheral Blood Stem Cell Transplantation
This randomized phase II trial studies how well giving low dose total-body irradiation (TBI)
with anti-thymocyte globulin followed by donor peripheral blood stem cell transplant (PBSCT)
works in treating patients with hematologic malignancies. Giving reduced intensity
total-body irradiation and anti-thymocyte globulin before a donor peripheral blood stem cell
transplant helps stop the growth of cancer cells. It may also stop the patient's immune
system from rejecting the donor's stem cells. When the healthy stem cells from a donor are
infused into the patient they may help the patient's bone marrow make stem cells, red blood
cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can
make an immune response against the body's normal cells. Giving total-body irradiation
together with antithymocyte globulin before transplant may stop this from happening.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of the study is a comparison of functional immune reconstitution at 6-9 months following transplant as measured by antibody response to vaccination with inactivated Hepatitis A or B vaccine.
A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution.
Up to 9 months following transplant
Amir Toor, MD
Massey Cancer Center, VCU
United States: Institutional Review Board
|Massey Cancer Center/Virginia Commonwealth University||Richmond, Virginia 23298|