Journal
BLOOD
Volume 113, Issue 19, Pages 4771-4779Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2008-10-183723
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- Associazione Italiana Ricerca sul Cancro (Milano, Italy)
- FIRST University of Milano, Ministero dell'Universitae della Ricerca Scientifica (Rome, Italy)
- Ministero della Salute (Rome, Italy)
- Michelangelo Foundation for Advances in Cancer Research and Treatment (Milano, Italy)
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Haploidentical hematopoietic stem cell transplantation provides an option for patients with advanced hematologic malignancies lacking a compatible donor. In this prospective phase 1/2 trial, we evaluated the role of reduced-intensity conditioning (RIC) followed by early add-backs of CD8-depleted donor lymphocyte infusions (DLIs). The RIC regimen consisted of thiotepa, fludarabine, cyclophosphamide, and 2 Gy total body irradiation. Twenty-eight patients with advanced lym-phoproliferative diseases (n = 24) or acute myeloid leukemia ( n = 4) were enrolled. Ex vivo and in vivo T-cell depletion was carried out by CD34(+) cell selection and alemtuzumab treatment. The 2-year cumulative incidence of nonrelapse mortality was 26% and the 2-year overall survival (OS) was 44%, with a better outcome for patients with chemosensitive disease (OS, 75%). Overall, 54 CD8-depleted DLIs were administered to 23 patients (82%) at 3 different dose levels without loss of engraftment or acute toxicities. Overall, 6 of 23 patients ( 26%) developed grade II-IV graft-versus-host disease, mainly at dose level 2. In conclusion, our RIC regimen allowed a stable engraftment with a rather low nonrelapse mortality in poor-risk patients; OS is encouraging with some long-term remissions in lymphoid malignancies. CD8-depleted DLIs are feasible and promote the immune reconstitution. (Blood. 2009;113:4771-4779)
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