Biomarker Study of Chemotherapy Resistance and Outcomes in Samples From Older Patients With Acute Myeloid Leukemia
NCT ID: NCT01421875
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
257 participants
OBSERVATIONAL
2011-08-17
2011-10-17
Brief Summary
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PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and outcomes in samples from older patients with acute myeloid leukemia.
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Detailed Description
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* Delineate the spectrum of genetic and epigenetic lesions occurring in elderly patients with acute myeloid leukemia (AML).
* Determine the biological functions perturbed by these lesions.
* Identify and validate lesions or pathways that are most highly associated with chemo-sensitive and chemo-refractory disease, and with adverse outcome in elderly AML.
* Identify potential classifiers and biomarker lesions that we can then evaluate prospectively in the E2906 trial which is about to begin enrollment.
OUTLINE: DNA and RNA extracted from cell samples are analyzed for genetic and epigenetic expression by Agilent SureSelect sequencing, Illumina HiSeq2000 platform coding and sequencing, DNA methylation, and microarray assays. Results are then associated with patients' overall survival, progression-free survival, and complete response rate. Results are also analyzed assessing the prognostic relevance of known mutations and epigenetic alterations that have shown to have an impact on overall survival and response to therapy in younger patients with acute myeloid leukemia (AML) in E1900 including, but not limited to, FLT3, DNMT3A, IDH1, IDH2, TET2, ASXL1, WT1, and MLL, and 15-gene DNA methylation classifier, and with novel recurrent mutations identified by other AML-profiling efforts.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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DNA methylation analysis
RNA analysis
gene expression analysis
microarray analysis
nucleic acid sequencing
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Subset of patients diagnosed with acute myeloid leukemia (AML) enrolled on E3999
* AML resistant or sensitive to chemotherapy
* Mononuclear cell samples available
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
61 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Ross Levine, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Other Identifiers
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ECOG-E3999T4
Identifier Type: -
Identifier Source: secondary_id
CDR0000709403
Identifier Type: -
Identifier Source: org_study_id
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