MULTICENTER PHASE III BLINDED STUDY OF DAB389IL-2 IN CTCL > 4 PREVIOUS THERAPIES

本III期研究旨在评价以下药物的疗效和安全性： IL-2受体（IL-2 R）靶向的细胞毒素DAB 389 IL-2作为二线 皮肤T细胞淋巴瘤（CTCL）患者的治疗， >4次既往治疗或IVa期疾病患者在>1次既往治疗后 治疗，有复发或持续性疾病。 皮肤t细胞淋巴瘤 是一组异质性的恶性肿瘤的T辅助/诱导 淋巴细胞亚群 在50%的病例中，这些恶性细胞表达IL-2 R 如免疫组织化学染色所示。

This Phase III study is designed to evaluate the efficacy and safety of an IL-2 receptor (IL-2R) targeted cytotoxin DAB389IL-2 as second line therapy in patient with cutaneous T-cell lymphoma (CTCL) who, following >4 previous therapies or stage IVa disease patients following >1 previous therapy, have recurrent or persistent disease. Cutaneous T-cell lymphoma is a heterogeneous group of malignancies of the T-helper/inducer lymphocyte subset. In 50% of cases, these malignant cells express IL-2R as demonstrated by immunohistochemical staining.