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This phase II trial studies how well FMS inhibitor JNJ-40346527 works in treating participants with acute myeloid leukemia that has come back or does not respond to treatment. FMS inhibitor JNJ-40346527 may stop the growth of cancer cells by blocking some of the microenvironmental signals needed for cell growth.
Evaluate preliminary efficacy of JNJ-40346527 in participants with relapsed/refractory AML.
1. Best objective response rate (>PR).
Assess safety and survival associated with JNJ-40346527 to treat participants with relapsed/refractory AML. Assess the duration of disease response associated with JNJ-40346527.
1. Overall incidence of treatment-related and non-treatment related toxicity.
2. Duration of response.
3. 12-month event-free survival.
4. 12-month overall survival.
1. Evaluate the pharmacokinetics of JNJ-40346527 and effective inhibition of CSF-1R in marrow aspirates using plasma inhibitory assays, with established CSF-1R-sensitive cell lines.
2. Identify the effect of JNJ-40346527 on leukemia cells and the immune microenvironment.
3. Analyze the frequency of mutations using genomic deoxyribonucleic acid (DNA) from leukemia participants to determine if there is a genetic signature that predicts response to JNJ-40346527.
4. Using ribonucleic acid (RNA) sequencing (RNAseq), identify an expression signature in CSF-1R+ cells that predicts patient response.
5. Evaluate the effect of JNJ-40346527 on immune cell populations (cytotoxic T cells, etc.) and phospho-signaling proteins by mass cytometry (CyTOF) analysis in pre- and post-treatment samples in order to identify biomarkers that predict patient response and prioritize potential combination strategies for future clinical trials.
6. Determine how leukemia cells change in response to CSF-1R inhibition by assessing cells collected pre- and post-treatment using an ex vivo sensitivity to a panel of small molecule inhibitors to determine what new drug sensitivities may emerge in AML cells after CSF-1R inhibition.
Participants receive FMS inhibitor JNJ-40346527 orally (PO) twice a day (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up within 2 weeks, at 4-6 weeks until death or minimum of 12 months.
Recurrent Adult Acute Myeloid Leukemia
FMS Inhibitor JNJ-40346527, Pharmacokinetic Study
OHSU Knight Cancer Institute
Not yet recruiting
OHSU Knight Cancer Institute
Published on BioPortfolio: 2018-06-20T02:25:11-0400
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A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.
Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.
An extramedullary tumor of immature MYELOID CELLS or MYELOBLASTS. Granulocytic sarcoma usually occurs with or follows the onset of ACUTE MYELOID LEUKEMIA.
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A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.
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