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• W2057133022 abstract "In patients who undergo autologous peripheral blood stem cell transplantation (PBSCT) for severe autoimmune disorders, a preparative regimen that optimizes immunosuppression without excessive myelotoxicity would potentially have favorable safety and efficacy profiles. We are conducting a phase I trial of cyclophosphamide (CY) dose escalation (initial dose 200 mg/m2/day× 5, days −7 to −3) plus fludarabine (25 mg/m2/day× 5, days −7 to −3) and rabbit anti-thymocyte globulin (ATG) (thymoglobulin; 2.5 mg/kg/day× 3, days −5 to −3) followed by T-cell–depleted (TCD) autologous PBSCT in adults with systemic sclerosis (SSc). To date, 5 patients (median age, 44 years; range, 39–59 years) have been treated on this study. Each patient had satisfactory PBSC collection with one 4-hour large-volume leukapheresis after mobilization with CY (2000 mg/m2) plus G-CSF. To deplete T cellsin the PBSC product, we used a combination of CD34+ selection and ex vivo incubation with anti-CD3 antibody, which resulted in a mean 5.2-log reduction of T cells (range, 4.7–6.3 log). The final PBSC products contained a mean of 9.94 (range, 4.8–13.0)× 106 CD34+ cells/kg and 1.34 (range, 0.06–4.54)× 103 CD3+ cells/kg. The daily dose of CY was 200 mg/m2 in the first 3 patients and 400 mg/m2 in the next 2 patients. The mean half-life (t1/2) of CD3+ cells in these patients was biphasic: 0.8 days from day −7 to day −5 and 0.2 days from day −5 to day −3, correlating with ATG administration. In contrast, the mean t1/2 of CD3+ cells was 2.5 days in patients with hematologic malignancies receiving a myeloablative preparative regimen of CY, busulfan, and etoposide. After PBSCT, the median nadirs of WBC, ANC, and platelets were 1.2 (range, 0.4–2.0), 0.9 (range, 0.1–1.7) and 135 (range, 114–185)× 109/L, respectively. All patients are alive at a median of 8.5+ months (range, 6.9+ to 17.5+ months) after PBSCT. Compared with pre-PBSCT levels, Rodnan total skin score (TSS) decreased by 4, 10, 11, and 15 points, respectively, in 4 patients and increased by 8 points in 1 patient, who also developed SSc renal crisis requiring hemodialysis at 12 months after PBSCT. Of 4 patients with improved TSS, 1 has worsening polymyositis and 1 has recurrence of palpable tendon friction rubs. Even at the lowest CY dose, this immunosuppressive regimen provides significantly greater and more rapid T-cell kill than a conventional myeloablative regimen. The efficacy of this regimen and TCD PBSCT in SSc is encouraging. but requires longer follow-up and experience with a larger number of patients." @default.
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• W2057133022 date "2005-02-01" @default.
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• W2057133022 title "Intensive immunosuppression and transplantation of T-cell depleted autologous peripheral blood stem cells in patients with systemic sclerosis: An ongoing phase I trial" @default.
• W2057133022 doi "https://doi.org/10.1016/j.bbmt.2004.12.193" @default.
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