Studying Tissue and Blood Samples from Patients with Acute Myeloid Leukemia

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedBiomarker/Laboratory analysisNot specifiedCALGB 20202
NCI-2009-00457, CDR0000617738, NCT00900224

Trial Description

Summary

This research study is looking at tissue and blood samples from patients with acute myeloid leukemia. Studying samples of tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. Prospectively obtain specimens required for diagnostic review and molecular characterization ensuring eligibility for CALGB Leukemia Committee Clinical trials (for clinical trials designed to enroll specific molecular subtypes, results to determine eligibility will be reported to treating physicians no more than 3 business days after specimen receipt at the CALGB Leukemia Tissue Bank).

II. Determine the frequency of specific gene markers (i.e., FLT3 ITD, CBF, MLL PTD, NPM1, KIT, RAS, CEBPA, WT1, JAK2, RUNX1, TET2, CBL, IDH1 and IDH2, ASXL1, DNMT3A mutations, aberrant BAALC, ERG, FLT3, MN1, EVI1, and APP) over-expression and levels of promoter methylation of specific genes (e.g., ESR1, WIT1, P15, MYOD1, ID4, DPK) in defined cytogenetic subgroups of acute myeloid leukemia (AML) patients.

III. Correlate the above gene markers with clinical and laboratory parameters in defined cytogenetic subgroups of AML patients.

IV. Correlate the above gene markers with clinical outcome (i.e., complete remission [CR], disease-free survival [DFS], cumulative incidence of relapse [CIR], and overall survival [OS]) in defined cytogenetic subgroups of AML patients.

V. Identify specific microarray multi-gene expression signatures in defined cytogenetic subgroups of AML patients.

VI. Correlate specific microarray multi-gene expression signatures with clinical and laboratory parameters in defined cytogenetic subgroups of AML patients.

VII. Correlate specific microarray multi-gene expression signatures with clinical outcome (i.e., CR, DFS, CIR, and OS) in defined cytogenetic subgroups of AML patients.

VIII. Identify specific microarray multi-microRNA (miR) expression signatures in defined cytogenetic subgroups of AML patients.

IX. Correlate specific microarray multi-miR expression signatures with clinical and laboratory parameters in defined cytogenetic subgroups of AML patients.

X. Correlate specific microarray multi-miR expression signatures with clinical outcome (i.e., CR, DFS, CIR, and OS) in defined cytogenetic subgroups of AML patients.

XI. Explore the relative contribution of prognostic gene markers (i.e., FLT3 ITD, MLL, PTD, NPM1, KIT, RAS, CEBPA, WT1, JAK2, and DNMT3A mutations, and aberrant BAALC, ERG, FLT3, MN1, and EVI1 over-expression), levels of promoter methylation of specific genes (e.g., ESR1, WIT1, P15, MYOD1, ID4, DPK), and microarray gene and miR expression signatures in defined cytogenetic subgroups of AML.

XII. Determine changes in these molecular markers and microarray gene and miR expression signatures at CR and relapse and the influence that these changes have on subsequent clinical course.

XIII. Correlate the relative level of nuclear pSTAT5 and pERK in bone marrow blasts with outcome (EFS, CR, DFS, OS).

OUTLINE:

Previously procured and archived bone marrow aspirate samples, blood and buccal cell samples, and bone marrow biopsy slides are analyzed for FLT3 ITD, MLL PTD, NPM1, KIT, KRAS, NRAS, CEBPA, WT1, JAK2, RUNX1, TET2, ASXL1, IDH1 and IDH2, CBL, and DNMT3A mutations, CBF fusion genes, levels of BAALC, ERG, EVI1, MN1, and APP microarray gene-expression, microRNA gene-expression signature, levels of methylation of genes silenced in AML, and genomic DNA by PCR amplification, RT-PCR, and denaturing high-performance liquid chromatography.

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed acute myeloid leukemia (AML)

AML diagnostic bone marrow and/or blood samples from patients enrolled on CLB-9720, CLB-9621 (all cytogenetic subtypes), and CALGB-19808 (abnormal cytogenetics only)

AML tissue samples from companion Leukemia Tissue Bank protocol CALGB-9665 and the companion cytogenetic protocol CALGB-8461

Tissue samples from previously untreated patients with AML considered for enrollment onto ongoing and future CALGB treatment protocols

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Clara Derber Bloomfield, Principal Investigator

Trial Sites

U.S.A.

Ohio
Columbus

Ohio State University Comprehensive Cancer Center

Clara Derber Bloomfield

Clara Derber Bloomfield
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00900224

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.