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

PXD101 在复发性或难治性皮肤及外周 T 细胞患者中的应用

• 批准号: 7605249
• 负责人: RAJ ADVANI
• 金额: $ 1.52万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605249
• 关键词: Antineoplastic Agents; Cells; Clinical Treatment; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cutaneous; Disease; Funding; Grant; In complete remission; Institution; Investigational Drugs; Label; Measures; Multiple Myeloma; Neoplasms; Non-Hodgkin' s Lymphoma; PXD101; Patients; Peripheral; Phase; Phase II Clinical Trials; Prior Therapy; Progressive Disease; Randomized; Rate; Recurrence; Recurrent disease; Refractory; Relapse; Research; Research Personnel; Resources; Safety; Source; Stable Disease; T-Cell Lymphoma; Time; United States National Institutes of Health; Upper arm; design; partial response; response

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是一项开放标签，非随机，多中心，II期试验，用于评估研究性药物PXD101的功效和安全性，这是对至少一系列先前治疗的患者的单一疗法。 试验设计包括两个武器； ARM A仅包括复发性皮肤T细胞淋巴瘤（CTCL）的患者，ARM B包括复发或难治性周围T细胞T细胞淋巴瘤（PTCL）或其他T细胞淋巴瘤的患者。 PXD101是一种可用于治疗血液学肿瘤的有前途的抗肿瘤剂，目前正在II期临床试验中评估多发性骨髓瘤。非霍奇金淋巴瘤（NHL）患者的进一步临床试验将描述PXD101在这些疾病中的最佳使用。 该试验的主要目的是确定PXD101治疗的疗效，按照反应率（CR =完全响应； CRU = CR/未经证实； PR =部分反应； SD =稳定疾病； RD =复发性疾病；或使用Cheson等人的反应标准。 （Cheson 1999）。该试验的次要目标是检查响应时间，响应持续时间以及PXD101治疗后作为单一药物的安全性和存活率。