Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Biomarker/Laboratory analysis | Active | Not specified | NCI, Other | CDR0000617738 CALGB-20202, NCT00900224 |
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.
Further Study Information
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.
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)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial Lead Organizations/Sponsors
Cancer and Leukemia Group B
National Cancer Institute| Clara D. Bloomfield |  | Study Chair |
Trial Sites
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| U.S.A. | |||
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| Delaware | |||
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| Lewes | |||
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| Tunnell Cancer Center at Beebe Medical Center | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| Newark | |||
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| Helen F. Graham Cancer Center at Christiana Hospital | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| Florida | |||
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| Orlando | |||
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| Florida Hospital Cancer Institute at Florida Hospital Orlando | |||
| Lee M. Zehngebot | Ph: 407-303-5623 | ||
| Illinois | |||
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| Chicago | |||
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| Cancer and Leukemia Group B | |||
| Clara D. Bloomfield | Ph: 614-293-7518 | ||
| Email: clara.bloomfield@osumc.edu | |||
| University of Chicago Cancer Research Center | |||
| Wendy Stock | Ph: 773-834-7424 | ||
| Evanston | |||
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| CCOP - Evanston | |||
| David L. Grinblatt | Ph: 847-570-1381 | ||
| Iowa | |||
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| Iowa City | |||
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| Holden Comprehensive Cancer Center at University of Iowa | |||
| Daniel A Vaena | Ph: 800-237-1225 | ||
| Maine | |||
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| Augusta | |||
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| Harold Alfond Center for Cancer Care | |||
| Thomas Henry Openshaw | Ph: 207-973-4274 | ||
| Bangor | |||
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| CancerCare of Maine at Eastern Maine Medical Center | |||
| Thomas Henry Openshaw | Ph: 207-973-4274 | ||
| Maryland | |||
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| Baltimore | |||
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| Greenebaum Cancer Center at University of Maryland Medical Center | |||
| Maria R. Baer | Ph: 800-888-8823 | ||
| Elkton MD | |||
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| Union Hospital of Cecil County | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| Massachusetts | |||
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| Boston | |||
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| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |||
| Richard Maury Stone | Ph: 866-790-4500 | ||
| Massachusetts General Hospital | |||
| Richard Maury Stone | Ph: 866-790-4500 | ||
| Michigan | |||
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| Battle Creek | |||
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| Battle Creek Health System Cancer Care Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Big Rapids | |||
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| Mecosta County Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Grand Rapids | |||
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| Butterworth Hospital at Spectrum Health | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| CCOP - Grand Rapids | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Lacks Cancer Center at Saint Mary's Health Care | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Muskegon | |||
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| Mercy General Health Partners | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Reed City | |||
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| Spectrum Health Reed City Hospital | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Traverse City | |||
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| Munson Medical Center | |||
| Gilbert D Padula | Ph: 616-685-5225 | ||
| Missouri | |||
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| Columbia | |||
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| Ellis Fischel Cancer Center at University of Missouri - Columbia | |||
| Carl E. Freter | Ph: 573-882-7440 | ||
| Saint Louis | |||
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| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |||
| Geoffrey L Uy | Ph: 800-600-3606 | ||
| Email: info@siteman.wustl.edu | |||
| New Hampshire | |||
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| Lebanon | |||
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| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |||
| Marc Gautier | Ph: 800-639-6918 | ||
| Email: cancer.research.nurse@dartmouth.edu | |||
| New Jersey | |||
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| Camden | |||
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| Cancer Institute of New Jersey at Cooper University Hospital - Camden | |||
| Stephen Scott Grubbs | Ph: 302-733-6227 | ||
| New York | |||
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| Lake Success | |||
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| Monter Cancer Center of the North Shore-LIJ Health System | |||
| Jonathan Eliahu Kolitz | Ph: 516-562-3467 | ||
| Manhasset | |||
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| CCOP - North Shore University Hospital | |||
| Jonathan Eliahu Kolitz | Ph: 516-562-3467 | ||
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | |||
| Jonathan Eliahu Kolitz | Ph: 516-562-3467 | ||
| New Hyde Park | |||
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| Long Island Jewish Medical Center | |||
| Jonathan Eliahu Kolitz | Ph: 516-562-3467 | ||
| New York | |||
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| New York Weill Cornell Cancer Center at Cornell University | |||
| Gail J Roboz | Ph: 212-746-1848 | ||
| Syracuse | |||
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| SUNY Upstate Medical University Hospital | |||
| Teresa C. Gentile | Ph: 315-464-5476 | ||
| North Carolina | |||
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| Goldsboro | |||
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| Wayne Memorial Hospital, Incorporated | |||
| James N. Atkins | Ph: 919-580-0000 | ||
| Greenville | |||
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| Leo W. Jenkins Cancer Center at ECU Medical School | |||
| Adam S Asch | Ph: 252-744-2161 | ||
| Kinston | |||
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| Kinston Medical Specialists | |||
| Peter R. Watson | Ph: 252-559-2200 | ||
| Winston-Salem | |||
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| Wake Forest University Comprehensive Cancer Center | |||
| Bayard L. Powell | Ph: 336-713-6771 | ||
| Ohio | |||
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| Columbus | |||
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| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | |||
| Guido Marcucci | Ph: 866-627-7616 | ||
| Email: osu@emergingmed.com | |||
| Pennsylvania | |||
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| Pittsburgh | |||
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| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |||
| John Lister | Ph: 412-578-5000 | ||
| Vermont | |||
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| Berlin | |||
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| Mountainview Medical | |||
| Barbara W. Grant | Ph: 802-656-8990 | ||
| Burlington | |||
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| Vermont Cancer Center at University of Vermont | |||
| Barbara W. Grant | Ph: 802-656-8990 | ||
| Virginia | |||
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| Richmond | |||
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| Virginia Commonwealth University Massey Cancer Center | |||
| Prithviraj Bose | Ph: 804-628-1939 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00900224
Information obtained from ClinicalTrials.gov on February 14, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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