Hematologic Malignancy Clinical Trial
Official title:
A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted With Stem Cell Grafts From Haploidentical Donors After Reduced Intensity Conditioning
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning. Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen. Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation. ;
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