PXD101 IN PATIENTS WITH RECURRENT OR REFRACTORY CUTANEOUS AND PERIPHERAL T-CELL

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项开放标签、非随机、多中心的II期试验，旨在评估一种名为PXD101的研究药物在至少一种先前治疗失败的患者中的有效性和安全性。 试验设计包括两个手臂；A组仅包括复发性皮肤T细胞淋巴瘤(CTCL)患者，B组包括复发或难治性外周T细胞淋巴瘤(PTCL)或其他T细胞淋巴瘤患者。 PXD101是一种很有前途的抗肿瘤药物，用于治疗血液系统肿瘤，目前正在进行多发性骨髓瘤的II期临床试验。对非霍奇金淋巴瘤(NHL)患者的进一步临床试验将描绘出PXD101在这些疾病中的最佳使用。 这项试验的主要目的是根据Cheson等人的反应标准，根据缓解率(CR=完全缓解；CRU=CR/未确诊；PR=部分缓解；SD=稳定疾病；RD=复发性疾病；PD=进展性疾病)来确定PXD101治疗的疗效。(Cheson 1999)。该试验的次要目标是检查作为单一制剂的PXD101治疗后的起效时间、起效持续时间以及安全性和存活率。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label, non-randomized, multicenter, Phase II trial to assess the efficacy and safety of an investigational drug, PXD101, monotherapy in patients who have failed at least one line of prior therapy. The trial design includes two arms; arm A comprises only patients with recurrent Cutaneous T-cell lymphoma (CTCL), and arm B comprises patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) or other T-cell lymphomas. PXD101 is a promising antineoplastic agent for the treatment of hematological neoplasias, and is currently being evaluated in a Phase II clinical trial for the treatment of multiple myeloma. Further clinical trials in patients with Non-Hodgkin's lymphomas (NHL) will delineate the optimal use of PXD101 in these disorders. The primary objective of this trial is to determine the efficacy of PXD101 treatment as measured by response rate (CR=complete response; CRu=CR/unconfirmed; PR=partial response; SD=stable disease; RD=relapsed disease; or PD=progressive disease) using the response criteria of Cheson et al. (Cheson 1999). The secondary objective of the trial is to examine the time to response, the duration of response, and the safety and survival following PXD101 therapy as a single agent.