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。 本方案是研究者向FDA发起的研究药物ABT-751 IND（74，247）的一部分。 该方案由儿童白血病治疗进展（TACL）联盟制定，该联盟的运营中心位于CHLA，医学主任是Paul Gaynon博士。TACL的使命是开发使用新药的方案，使多次复发ALL患者的历史缓解率提高40%。 ABT-751药物由Abbott Laboratories提供用于本方案。这是一项多中心I/II期研究，其主要目的是1）在复发性儿科ALL患者中确定ABT-751在再诱导方案（还包括地塞米松、PEG-天冬酰胺酶和多柔比星）中的最大耐受剂量（MTD），2）确定是否有证据表明ABT-751将改善这种情况下的再诱导成功率。 本研究将分两部分进行。 在第1部分中，患者将根据标准剂量递增设计接受一系列ABT-751剂量之一治疗，以确定MTD。 在第2部分中，第1部分中接受MTD治疗的6例患者将作为多阶段II期设计的第一阶段，用于评价该再诱导方案的疗效。

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.