作者: D. L. Voliotis , S. Schmitz , P. Staib , H. Tesch , V. Diehl
DOI: 10.1007/978-3-642-71960-8_135
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摘要: Abstract IL-2 has been shown to induce several mechanisms of MHC-restricted and MHC-unrestricted cytotoxicity against leukemic blasts in vitro vivo. Also it is known that patients with AML have a reduced or defective NK-cell function. Based on these findings we designed phase I/II trial intermediate high-dose IL-2 study the feasibility, immunomodulation therapeutic efficacy continuous escalating regimen partial remission refractory relapsed disease who were not suitable for further chemotherapy. Patients planned receive 4 cycles recombinant (Proleukin, Chiron GmbH) from d1–d5 doses 4.5 × 106 IU/m2 18 IU/m2. Therapy was given civ resting period at least 48 hours between each cycle. As March 1997 five treated. Highest dose level applicable 2/5 patients. In 3/5 continuation therapy required reduction after initial escalation. With this individual dose-modification all 5 over tolerable toxicity. Immunological monitoring (FACS) showed marked lymphocytic stimulation (up > 70% PBMNC) induction CD3+/CD8+/TCRαβ+ cytotoxic T-cells up 50% PBMNC. Lymphocyte detected even low-dose (4.5 1061U/m2) persisted end application 2 weeks). bone marrow observed. One responders (1/5 patients) myelodysplastic syndrome blast < 5% BM. This patient treated maintenance s.c. an ambulatory basis increase hemoglobin platelet levels 7 months requiring no more transfusions being very good condition without showing any signs activity.