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Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00900224
Collaborator
National Cancer Institute (NCI) (NIH)
529
Enrollment
77
Locations
6.9
Patients Per Site

Study Details

Study Description

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 Phase
  • 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

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 :
Jun 1, 2008
Actual Primary Completion Date :
Dec 1, 2015

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Presence of molecular markers that fulfill eligibility criteria in diagnostic samples from AML patients considered for CALGB therapeutic protocols [baseline]

  2. Frequency of specific single-gene markers over-expression and levels of promoter methylation of specific genes [baseline]

  3. Predictive value of specific single-gene markers [baseline]

  4. Microarray multi-gene and multi-miR expression signatures [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Camino Medical Group - Treatment Center Mountain View California United States 94040
2 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
3 CCOP - Christiana Care Health Services Newark Delaware United States 19713
4 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia United States 20007
5 Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida United States 32803-1273
6 Illinois CancerCare - Bloomington Bloomington Illinois United States 61701
7 St. Joseph Medical Center Bloomington Illinois United States 61701
8 Illinois CancerCare - Canton Canton Illinois United States 61520
9 Illinois CancerCare - Carthage Carthage Illinois United States 62321
10 University of Illinois Cancer Center Chicago Illinois United States 60612-7243
11 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
12 Eureka Community Hospital Eureka Illinois United States 61530
13 Illinois CancerCare - Eureka Eureka Illinois United States 61530
14 Evanston Hospital Evanston Illinois United States 60201-1781
15 Galesburg Clinic, PC Galesburg Illinois United States 61401
16 Illinois CancerCare - Havana Havana Illinois United States 62644
17 Illinois CancerCare - Kewanee Clinic Kewanee Illinois United States 61443
18 Illinois CancerCare - Macomb Macomb Illinois United States 61455
19 Illinois CancerCare - Monmouth Monmouth Illinois United States 61462
20 OSF Holy Family Medical Center Monmouth Illinois United States 61462
21 BroMenn Regional Medical Center Normal Illinois United States 61761
22 Community Cancer Center Normal Illinois United States 61761
23 Illinois CancerCare - Community Cancer Center Normal Illinois United States 61761
24 Community Hospital of Ottawa Ottawa Illinois United States 61350
25 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
26 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
27 Illinois CancerCare - Pekin Pekin Illinois United States 61603
28 Proctor Hospital Peoria Illinois United States 61614
29 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
30 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
31 Methodist Medical Center of Illinois Peoria Illinois United States 61636
32 OSF St. Francis Medical Center Peoria Illinois United States 61637
33 Illinois CancerCare - Peru Peru Illinois United States 61354
34 Illinois Valley Community Hospital Peru Illinois United States 61354
35 Illinois CancerCare - Princeton Princeton Illinois United States 61356
36 Illinois CancerCare - Spring Valley Spring Valley Illinois United States 61362
37 Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana United States 46845
38 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1002
39 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
40 CancerCare of Maine at Eastern Maine Medical Center Bangor Maine United States 04401
41 Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland United States 21201
42 Union Hospital of Cecil County Elkton Maryland United States 21921
43 Massachusetts General Hospital Boston Massachusetts United States 02114
44 Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts United States 02115
45 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts United States 02115
46 Battle Creek Health System Cancer Care Center Battle Creek Michigan United States 49017
47 Mecosta County Medical Center Big Rapids Michigan United States 49307
48 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503
49 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
50 Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan United States 49503
51 Mercy General Health Partners Muskegon Michigan United States 49444
52 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
53 Munson Medical Center Traverse City Michigan United States 49684
54 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
55 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri United States 63110
56 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
57 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
58 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
59 Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York United States 11042
60 CCOP - North Shore University Hospital Manhasset New York United States 11030
61 Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York United States 11030
62 Long Island Jewish Medical Center New Hyde Park New York United States 11040
63 New York Weill Cornell Cancer Center at Cornell University New York New York United States 10021
64 Mount Sinai Medical Center New York New York United States 10029
65 SUNY Upstate Medical University Hospital Syracuse New York United States 13210
66 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
67 Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina United States 28233-3549
68 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
69 Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina United States 27834
70 Pardee Memorial Hospital Hendersonville North Carolina United States 28791
71 Kinston Medical Specialists Kinston North Carolina United States 28501
72 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
73 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210-1240
74 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224-1791
75 Mountainview Medical Berlin Vermont United States 05602
76 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401
77 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Clara Bloomfield, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00900224
Other Study ID Numbers:
  • CALGB-20202
  • CALGB-20202
  • CDR0000617738
First Posted:
May 12, 2009
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 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:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Aug 3, 2022