Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplantation
- The first 10 participants (Group 1) will receive a conditioning regimen of total body
irradiation (TBI) before the stem cell transplant. It is possible this conditioning
regimen may suppress the immune system enough. This can cause the stem cell transplant
to be rejected to quickly. It is necessary for the transplant to begin to grow before
it is rejected. If the participants in Group 1 reject their stem cell transplant too
quickly, the next group of 10 participants (Group 2) will receive a medication called
fludarabine for three days before the TBI. The purpose of adding fludarabine is to
suppress the immune system enough to allow the transplant to initially grow. An
additional RLI may be given 2 weeks after the first RLI.
- Before the conditioning regimen (either TBI or fludarabine), participants will undergo
a procedure to collect their white blood cells called leukapheresis. The white blood
cells collected will then be frozen and stored and given to the participant as an RLI
on Day 38 after their stem cell transplant.
- Participants will receive their donor's stem cells about 4-6 hours after TBI. They will
also receive the following medications to prevent GVHD: Cyclosporine orally until about
day 35 and Mycophenolate Mofetil (MMF) orally until 21 days after the stem cell
transplant.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To develop a conditioning regimen achieving initial mixed chimerism of HLA-mismatched related donor CD34+ cells without GVHD
2 years
No
Bimal Dey, MD
Principal Investigator
Massachuestts General Hospital
United States: Institutional Review Board
07-068
NCT00981760
July 2008
June 2010
Name | Location |
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Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |