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

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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