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Active, not recruitingNCT00900224Updated Aug 31, 2023

Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia

An observational study in Leukemia, sponsored by Alliance for Clinical Trials in Oncology. Active, not recruiting at 77 sites in United States. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Alliance for Clinical Trials in Oncology · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
529
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Leukemia

Keywords

  • 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
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 529 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with acute myeloid leukemia

Eligibility 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)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
529 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • GeneticDNA analysis
  • GeneticDNA methylation analysis
  • Geneticgene expression analysis
  • Geneticmutation analysis
  • Geneticpolymerase chain reaction
  • Geneticreverse transcriptase-polymerase chain reaction
  • Otherhigh performance liquid chromatography
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  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

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Study locations

77 sites
  • Camino Medical Group - Treatment Center
    Mountain View, California 94040, United States
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware 19958, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    Washington, District of Columbia 20007, United States
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
    Orlando, Florida 32803-1273, United States
  • Illinois CancerCare - Bloomington
    Bloomington, Illinois 61701, United States
  • St. Joseph Medical Center
    Bloomington, Illinois 61701, United States
  • Illinois CancerCare - Canton
    Canton, Illinois 61520, United States
  • Illinois CancerCare - Carthage
    Carthage, Illinois 62321, United States
  • University of Illinois Cancer Center
    Chicago, Illinois 60612-7243, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Eureka Community Hospital
    Eureka, Illinois 61530, United States
  • Illinois CancerCare - Eureka
    Eureka, Illinois 61530, United States
  • Evanston Hospital
    Evanston, Illinois 60201-1781, United States
  • Galesburg Clinic, PC
    Galesburg, Illinois 61401, United States
  • Illinois CancerCare - Havana
    Havana, Illinois 62644, United States
  • Illinois CancerCare - Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • Illinois CancerCare - Macomb
    Macomb, Illinois 61455, United States
  • Illinois CancerCare - Monmouth
    Monmouth, Illinois 61462, United States
  • OSF Holy Family Medical Center
    Monmouth, Illinois 61462, United States
  • BroMenn Regional Medical Center
    Normal, Illinois 61761, United States
  • Community Cancer Center
    Normal, Illinois 61761, United States
  • Illinois CancerCare - Community Cancer Center
    Normal, Illinois 61761, United States
  • Community Hospital of Ottawa
    Ottawa, Illinois 61350, United States
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
    Ottawa, Illinois 61350, United States
  • Cancer Treatment Center at Pekin Hospital
    Pekin, Illinois 61554, United States
  • Illinois CancerCare - Pekin
    Pekin, Illinois 61603, United States
  • Proctor Hospital
    Peoria, Illinois 61614, United States
  • CCOP - Illinois Oncology Research Association
    Peoria, Illinois 61615, United States
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
    Peoria, Illinois 61615, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61636, United States
  • OSF St. Francis Medical Center
    Peoria, Illinois 61637, United States
  • Illinois CancerCare - Peru
    Peru, Illinois 61354, United States
  • Illinois Valley Community Hospital
    Peru, Illinois 61354, United States
  • Illinois CancerCare - Princeton
    Princeton, Illinois 61356, United States
  • Illinois CancerCare - Spring Valley
    Spring Valley, Illinois 61362, United States
  • Fort Wayne Medical Oncology and Hematology
    Fort Wayne, Indiana 46845, United States
  • Holden Comprehensive Cancer Center at University of Iowa
    Iowa City, Iowa 52242-1002, United States
  • Harold Alfond Center for Cancer Care
    Augusta, Maine 04330, United States
  • CancerCare of Maine at Eastern Maine Medical Center
    Bangor, Maine 04401, United States
  • Greenebaum Cancer Center at University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Union Hospital of Cecil County
    Elkton, Maryland 21921, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber/Brigham and Women's Cancer Center
    Boston, Massachusetts 02115, United States
  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Battle Creek Health System Cancer Care Center
    Battle Creek, Michigan 49017, United States
  • Mecosta County Medical Center
    Big Rapids, Michigan 49307, United States
  • Butterworth Hospital at Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • CCOP - Grand Rapids
    Grand Rapids, Michigan 49503, United States
  • Lacks Cancer Center at Saint Mary's Health Care
    Grand Rapids, Michigan 49503, United States
  • Mercy General Health Partners
    Muskegon, Michigan 49444, United States
  • Spectrum Health Reed City Hospital
    Reed City, Michigan 49677, United States
  • Munson Medical Center
    Traverse City, Michigan 49684, United States
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
    Columbia, Missouri 65203, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    Saint Louis, Missouri 63110, United States
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756-0002, United States
  • Cancer Institute of New Jersey at Cooper - Voorhees
    Voorhees, New Jersey 08043, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
  • Monter Cancer Center of the North Shore-LIJ Health System
    Lake Success, New York 11042, United States
  • CCOP - North Shore University Hospital
    Manhasset, New York 11030, United States
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
    Manhasset, New York 11030, United States
  • Long Island Jewish Medical Center
    New Hyde Park, New York 11040, United States
  • New York Weill Cornell Cancer Center at Cornell University
    New York, New York 10021, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • SUNY Upstate Medical University Hospital
    Syracuse, New York 13210, United States
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    Chapel Hill, North Carolina 27599-7295, United States
  • Presbyterian Cancer Center at Presbyterian Hospital
    Charlotte, North Carolina 28233-3549, United States
  • Wayne Memorial Hospital, Incorporated
    Goldsboro, North Carolina 27534, United States
  • Leo W. Jenkins Cancer Center at ECU Medical School
    Greenville, North Carolina 27834, United States
  • Pardee Memorial Hospital
    Hendersonville, North Carolina 28791, United States
  • Kinston Medical Specialists
    Kinston, North Carolina 28501, United States
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210-1240, United States
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224-1791, United States
  • Mountainview Medical
    Berlin, Vermont 05602, United States
  • Fletcher Allen Health Care - University Health Center Campus
    Burlington, Vermont 05401, United States
  • Virginia Commonwealth University Massey Cancer Center
    Richmond, Virginia 23298-0037, United States
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References and documents

Publications

  • Becker H, Marcucci G, Maharry K, Radmacher MD, Mrozek 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. PubMed 20442368 ↗
  • Fobare S, Kohlschmidt J, Ozer HG, Mrozek K, Nicolet D, Mims AS, Garzon R, Blachly JS, Orwick S, Carroll AJ, Stone RM, Wang ES, Kolitz JE, Powell BL, Oakes CC, Eisfeld AK, Hertlein E, Byrd JC. Molecular, clinical, and prognostic implications of PTPN11 mutations in acute myeloid leukemia. Blood Adv. 2022 Mar 8;6(5):1371-1380. doi: 10.1182/bloodadvances.2021006242. PubMed 34847232 ↗
  • Mims AS, Kohlschmidt J, Borate U, Blachly JS, Orwick S, Eisfeld AK, Papaioannou D, Nicolet D, Mromicronzek K, Stein E, Bhatnagar B, Stone RM, Kolitz JE, Wang ES, Powell BL, Burd A, Levine RL, Druker BJ, Bloomfield CD, Byrd JC. A precision medicine classification for treatment of acute myeloid leukemia in older patients. J Hematol Oncol. 2021 Jun 23;14(1):96. doi: 10.1186/s13045-021-01110-5. PubMed 34162404 ↗
  • Walker CJ, Kohlschmidt J, Eisfeld AK, Mrozek K, Liyanarachchi S, Song C, Nicolet D, Blachly JS, Bill M, Papaioannou D, Oakes CC, Giacopelli B, Genutis LK, Maharry SE, Orwick S, Archer KJ, Powell BL, Kolitz JE, Uy GL, Wang ES, Carroll AJ, Stone RM, Byrd JC, de la Chapelle A, Bloomfield CD. Genetic Characterization and Prognostic Relevance of Acquired Uniparental Disomies in Cytogenetically Normal Acute Myeloid Leukemia. Clin Cancer Res. 2019 Nov 1;25(21):6524-6531. doi: 10.1158/1078-0432.CCR-19-0725. Epub 2019 Aug 2. PubMed 31375516 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00900224
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
Jun 2008
Primary completion
Dec 2015
Last update
Aug 31, 2023

Study contacts

Clara Bloomfield, MD
study chair · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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