IGF::CT::IGF DEVELOPMENT OF PRAEDICARE DX AS CDX FOR AMLPERIOD OF PERFORMANCE: SEPTEMBER 19, 2014 THROUGH SEPTEMBER 18, 2015

研究人员建议，使用Eutropics的Praedicare Dx线粒体启动评估法，评估某些血液恶性肿瘤对耐受性小分子细胞周期蛋白依赖性激酶抑制剂黄匹吡醇与阿糖胞苷联合使用的敏感性。此外，研究者建议Eutropics对阿扎胞苷+来那度胺治疗的急性髓性白血病患者的某些骨髓抽吸标本和潜在的PBMC标本进行评估。这些检测的读数将与患者对治疗的反应相关，作为主要终点，总生存期（OS）和无病生存期（DFS）作为次要终点。耐受性将通过约翰霍普金斯大学的首席临床研究员Doug Smith博士提供人类AML患者来源的临床标本（外周血），Eutropics将对来自约翰霍普金斯大学治疗的患者的标本进行这项研究，这些样本目前作为可存活的冷冻标本保存在生物库中。斯坦福大学医院和诊所（Bruno Medeiros博士，首席临床研究员）将提供人类AML患者衍生的临床标本（骨髓抽吸），Eutropics将对这些目前作为可存活的冷冻标本进行生物银行的标本进行研究。来自梅奥诊所，斯科茨代尔，亚利桑那州和弗雷德哈奇癌症中心的样本也可能包括在研究中

It is proposed that Eutropics assess certain hematologic malignancies sensitivity to Tolero’s small molecule inhibitor of cyclin-dependent kinases, flavopiridol in combination with cytarabine, using Eutropics’ Praedicare Dx mitochondrial priming assessment assay. Further, it is proposed that Eutropics assess certain bone marrow aspirate and potentially PBMC specimens from patients presenting with acute myeloid leukemia treated with azacitidine+lenalidomide. The readouts from these assays will then be correlated to the patient response to treatment as a primary endpoint with overall survival (OS) and disease-free survival (DFS) as secondary endpoints. Tolero will make available human AML patient-derived clinical specimens (peripheral blood) via the principal clinical investigator Dr Doug Smith of Johns Hopkins University and Eutropics will perform this research on specimens derived from patients treated at Johns Hopkins University and from whence the samples are currently biobanked as viably frozen specimens. Stanford University Hospitals and Clinics (Dr. Bruno Medeiros, Prinicipal Clinical Investigator) will make available human AML patient-derived clinical specimens (bone marrow aspirates) and Eutropics will perform this research on these specimens currently biobanked as viably frozen specimens. Samples from the Mayo Clinic, Scottsdale, AZ and the Fred Hutch Cancer Center may also be included in the study