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Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00900224
First received: May 9, 2009
Last updated: July 15, 2013
Last verified: July 2013

May 9, 2009
July 15, 2013
June 2008
December 2018   (final data collection date for primary outcome measure)
  • Presence of molecular markers that fulfill eligibility criteria in diagnostic samples from AML patients considered for CALGB therapeutic protocols [ Designated as safety issue: No ]
  • Frequency of specific single-gene markers over-expression and levels of promoter methylation of specific genes [ Designated as safety issue: No ]
  • Correlation between gene markers with clinical and laboratory parameters [ Designated as safety issue: No ]
  • Correlation between gene markers and clinical outcomes [ Designated as safety issue: No ]
  • Frequency of specific single-gene markers over-expression and levels of promoter methylation of specific genes [ Designated as safety issue: No ]
  • Correlation between gene markers with clinical and laboratory parameters [ Designated as safety issue: No ]
  • Correlation between gene markers and clinical outcomes [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00900224 on ClinicalTrials.gov Archive Site
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Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia
Assessment of Novel Molecular Markers in Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue and blood 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 study is looking at tissue and blood samples from patients with acute myeloid leukemia.

OBJECTIVES:

  • 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 72 hours after specimen receipt at the repository).
  • 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, 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 patients with acute myeloid leukemia (AML).
  • Correlate these gene markers with clinical and laboratory parameters in these patients.
  • Correlate these gene markers with clinical outcome (i.e., complete remission [CR], disease-free survival [DFS], cumulative incidence of relapse [CIR], and overall survival [OS]) in these patients.
  • Identify specific microarray multi-gene expression signatures in these patients.
  • Correlate specific microarray multi-gene expression signatures with clinical and laboratory parameters in these patients.
  • Correlate specific microarray multi-gene expression signatures with clinical outcome (i.e., CR, DFS, CIR, and OS) in these patients.
  • Identify specific microarray multi-microRNA (miR) expression signatures in these patients
  • Correlate specific microarray multi-miR expression signatures with clinical and laboratory parameters in these patients.
  • Correlate specific microarray multi-miR expression signatures with clinical outcome (i.e., CR, DFS, CIR, and OS) in these patients.
  • Explore the relative contribution of prognostic gene markers (i.e., FLT3 ITD, MLL PTD, NPM1, KIT, RAS, CEBPA, WT1, and JAK2 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.
  • 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.
  • Correlate the relative level of nuclear pSTAT5 and pERK in bone marrow blasts with outcome (EFS, CR, DFS, OS).

OUTLINE: This is a multicenter study.

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, and CBL 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.

Observational
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Leukemia
  • Genetic: DNA analysis
  • Genetic: DNA methylation analysis
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: high performance liquid chromatography
  • Other: laboratory biomarker analysis
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Becker H, Marcucci G, Maharry K, Radmacher MD, Mrózek K, Margeson D, Whitman SP, Paschka P, Holland KB, Schwind S, Wu YZ, Powell BL, Carter TH, Kolitz JE, Wetzler M, Carroll AJ, Baer MR, Moore JO, Caligiuri MA, Larson RA, Bloomfield CD. Mutations of the Wilms tumor 1 gene (WT1) in older patients with primary cytogenetically normal acute myeloid leukemia: a Cancer and Leukemia Group B study. Blood. 2010 Aug 5;116(5):788-92. doi: 10.1182/blood-2010-01-262543. Epub 2010 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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December 2018   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia (AML)
  • Tissue samples from previously untreated patients with AML considered for enrollment onto ongoing and future CALGB treatment protocols
  • AML tissue samples from companion Leukemia Tissue Bank protocol CALGB-9665 and the companion cytogenetic protocol CALGB-8461
  • 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)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00900224
CDR0000617738, CALGB-20202
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Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Clara D. Bloomfield, MD Ohio State University Comprehensive Cancer Center
Alliance for Clinical Trials in Oncology
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP