CLINICAL TRIAL: PXD101 IN RECURRENT OR REFRACTORY CUTANEOUS AND PERIPHERAL T-CEL

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项开放标签、非随机、多中心、II期试验，旨在评估研究药物PXD 101单药治疗至少一线既往治疗失败的患者的疗效和安全性。 试验设计包括两组; A组仅包括复发性皮肤T细胞淋巴瘤（CTCL）患者，B组包括复发性或难治性外周T细胞淋巴瘤患者 （PTCL）或其他T细胞淋巴瘤。 PXD 101是一种很有前途的治疗血液肿瘤的药物，目前正在进行治疗多发性骨髓瘤的II期临床试验。在非霍奇金淋巴瘤（NHL）患者中进行的进一步临床试验将描述PXD 101在这些疾病中的最佳用途。 本试验的主要目的是确定PXD 101治疗的疗效，如通过反应率（CR=完全反应; CRu=CR/未证实; PR=部分反应; SD=疾病稳定; RD=复发性疾病;或PD=疾病进展），使用Cheson等人的缓解标准（Cheson 1999）。该试验的次要目的是检查PXD 101作为单一药物治疗后的反应时间，反应持续时间以及安全性和生存期。

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.