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; 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

有人提出，使用富营养化物的Praedicares DX Mitochrial启动评估测定法，富营营养的评估对Cyclin依赖性激酶的小分子抑制剂的某些血液学恶性肿瘤的敏感性，黄酮葡萄二醇与细胞押滨组合。此外，有人提出，富营养化物评估了某些骨髓抽吸物，并可能来自急性粒细胞丁胺+lenalidomide治疗的患者的患者的PBMC标本。然后，这些测定法的读数将与患者对治疗的反应作为主要终点（OS）（OS）和无疾病生存（DFS）作为次要终点相关。 Tolero将通过主要的Johns Hopkins University的主要临床研究员Doug Smith博士提供人类AML患者衍生的临床标本（外围血液），而富营养化人员将对约翰·霍普金斯大学（Johns Hopkins University）治疗的患者以及当前将样品当作生物友好的标本的患者进行这项研究。斯坦福大学医院和诊所（Bruno Medeiros博士，首席临床研究者）将提供人AML患者衍生的临床标本（骨髓吸质物），Eutropics将对当前被视为可猛烈冷冻的标本的这些标本进行此研究。研究中也可能包括来自Mayo诊所，Scottsdale，AZ和Fred Hutch Cancer Center的样品