Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Conditioning regimen with 2 Gy TBI with or without added fludarabine (90 mg/m2). Unmanipulated PBSC from HLA-identical sibling or HLA-matched related or unrelated donor
CHU Sart Tilman
Liège, Liege, Belgium
Incidence of acute GVHD in CD8-depleted versus unmanipulated groups
Time frame: 180 days
Incidence of chronic GVHD (overall and extensive) in CD8-depleted versus unmanipulated groups.
Time frame: 1-year
Incidence of graft rejection [according to the risk of transplant rejection (see table 1 above)] in CD8-depleted versus unmanipulated groups.
Time frame: 1-year
T cell (CD3) and myeloid (CD13) chimerism in CD8-depleted versus unmanipulated groups.
Time frame: 1-year and then long term
Quality and timing of immune reconstitution in CD8-depleted versus unmanipulated groups.
Time frame: 1-year
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