Biomarker Study of Chemotherapy Resistance and Outcomes in Samples From Older Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying blood samples from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

      PURPOSE: This research trial studies biomarkers related to chemotherapy resistance and
      outcomes in samples from older patients with acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  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.
    

Intervention name(s): DNA methylation analysis; RNA analysis; gene expression analysis; microarray analysis; nucleic acid sequencing; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled E3999 from whom samples were submitted for research
      
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); untreated adult acute myeloid leukemia; adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0)