CLINICAL TRIAL: ABT-751 COMBINED WITH DEXAMETHASONE, PEG-ASPARAGINASE, AND DOXOR

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。 该方案是研究人员与FDA就研究药物ABT-751发起的IND(74,247)的一部分。该方案是由儿童白血病治疗进展(TACL)联盟开发的，该联盟的运营中心位于CHLA，医疗主任是Paul Gaynon博士。S的使命是开发使用新药的方案，使多次复发急性淋巴细胞白血病患者的历史缓解率在40%的基础上有所改善。ABT-751药物由雅培实验室提供，用于该方案。这是一项多中心的I/II期研究，其主要目标是：1)在包括地塞米松、聚乙二醇门冬酰胺酶和阿霉素在内的再诱导方案中，为所有复发的儿科患者建立ABT-751的最大耐受量(MTD)；2)确定是否有证据表明，在这种情况下，ABT-751将提高再诱导成功率。这项研究将分两部分进行。在第一部分中，患者将根据标准剂量递增设计接受ABT-751系列剂量中的一种治疗，以建立MTD。在第二部分中，第一部分中在MTD接受治疗的6名患者将作为多阶段II期设计的第一阶段，该阶段将用于评估这种再诱导方案的疗效。

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 protocol is part of an investigator initiated IND (74,247) with the FDA for the investigational drug ABT-751. The protocol has been developed by the Therapeutic Advances in Childhood Leukemia (TACL) consortium in which the Operations Center is located at CHLA and the medical director is Dr. Paul Gaynon. TACL s mission is to develop protocols using new drugs in which provide an improvement upon the historical remission rate of 40% for patient treated with multiple relapsed ALL. ABT-751 drug is provided for use in this protocol by Abbott Laboratories. This is a multi-center phase I/II study whose primary objectives are 1) to establish in relapsed pediatric ALL patients a maximum tolerated dose (MTD) of ABT-751 in the context of a re-induction regimen that also includes dexamethasone, PEG-asparaginase, and doxorubicin, and 2) to determine whether there is evidence that ABT-751 will improve re-induction success rate in this context. The study will be performed in two parts. In Part 1, patients will be treated at one of a series of doses of ABT-751 according to a standard dose escalation design in order to establish the MTD. In Part 2, the 6 patients treated at the MTD in Part 1 will serve as the first stage of a multistage Phase II design, which will be used to evaluate the efficacy of this re-induction regimen.