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Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00900224
Recruitment Status : Active, not recruiting
First Posted : May 12, 2009
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
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

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 529 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Novel Molecular Markers in Acute Myeloid Leukemia
Actual Study Start Date : June 2008
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Presence of molecular markers that fulfill eligibility criteria in diagnostic samples from AML patients considered for CALGB therapeutic protocols [ Time Frame: baseline ]
  2. Frequency of specific single-gene markers over-expression and levels of promoter methylation of specific genes [ Time Frame: baseline ]
  3. Predictive value of specific single-gene markers [ Time Frame: baseline ]
  4. Microarray multi-gene and multi-miR expression signatures [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
bone marrow aspirate, whole blood, buccal cell sample and bone marrow biopsy

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with acute myeloid leukemia
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900224


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Clara Bloomfield, MD Ohio State University Comprehensive Cancer Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00900224    
Other Study ID Numbers: CALGB-20202
CALGB-20202
CDR0000617738 ( Registry Identifier: NCI Physician Reference Desk )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Keywords provided by Alliance for Clinical Trials in Oncology:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
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
untreated childhood acute myeloid leukemia and other myeloid malignancies
secondary acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms