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

IGF::CT::IGF 开发的 PRAEDICARE DX 作为 CDX 的多个表现周期：2014 年 9 月 19 日至 2015 年 9 月 18 日

• 批准号: 8934461
• 负责人: MICHAEL CARDONE
• 金额: $ 149.97万
• 依托单位: EUTROPICS PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2016-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8934461
• 关键词: Acute Myelocytic Leukemia; Agreement; Aspirate substance; Azacitidine; Biological Assay; Biological Markers; Blinded; Bone Marrow; Cancer Center; Clinic; Clinical; Clinical Investigator; Collaborations; Confidentiality of Patient Information; Cyclin-Dependent Kinase Inhibitor; Cytarabine; Data; Development; Disease-Free Survival; Freezing; Guidelines; Health Insurance Portability and Accountability Act; Hematologic Neoplasms; Housing; Human; Individual; Metric; Mitochondria; Outcome; Patients; Peptides; Performance; Peripheral Blood Mononuclear Cell; Publications; Regulation; Research; Sampling; Specimen; Universities; University Hospitals; biobank; flavopiridol; interest; lenalidomide; peripheral blood; response; small molecule

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

建议Eutropics使用Eutropics的Praedicare Dx线粒体引发评估试验评估某些血液恶性肿瘤对Tolero的细胞周期蛋白依赖性激酶小分子抑制剂flavopiridol联合阿糖胞苷的敏感性。此外，建议Eutropics评估接受阿扎胞苷+来那度胺治疗的急性髓性白血病患者的某些骨髓穿刺液和潜在PBMC标本。然后将这些测定的读数与作为主要终点的患者对治疗的反应以及作为次要终点的总生存期（OS）和无病生存期（DFS）相关联。Tolero将通过约翰霍普金斯大学的主要临床研究者Doug Smith博士提供人AML患者来源的临床标本（外周血），而Eutropics将对来自约翰霍普金斯大学治疗患者的标本进行本研究，这些标本目前作为生物库中的活冻存标本。斯坦福大学医院和诊所（Dr. Bruno Medeiros，首席临床研究员）将提供人AML患者来源的临床标本（骨髓穿刺液），Eutropics将对目前作为生物样本库的活冻存标本进行本研究。来自马约诊所（斯科茨代尔，AZ）和Fred Hutch癌症中心的样本也可纳入本研究