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Assessment of Novel Molecular Markers in Acute Myeloid Leukemia


N/A
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Assessment of Novel Molecular Markers in 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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Presence of molecular markers that fulfill eligibility criteria in diagnostic samples from AML patients considered for CALGB therapeutic protocols

Safety Issue:

No

Principal Investigator

Clara D. Bloomfield, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000617738

NCT ID:

NCT00900224

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
University of Illinois Cancer CenterChicago, Illinois  60612-7243
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
St. Joseph Medical CenterBloomington, Illinois  61701
Eureka Community HospitalEureka, Illinois  61530
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Mecosta County Medical CenterBig Rapids, Michigan  49307
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Mountainview MedicalBerlin, Vermont  05602
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Evanston HospitalEvanston, Illinois  60201-1781
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Pardee Memorial HospitalHendersonville, North Carolina  28791
Harold Alfond Center for Cancer CareAugusta, Maine  04330
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Kinston Medical SpecialistsKinston, North Carolina  28501
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
OSF Holy Family Medical CenterMonmouth, Illinois  61462
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
Mercy General Health PartnersMuskegon, Michigan  49443
Camino Medical Group - Treatment CenterMountain View, California  94040
Spectrum Health Reed City HospitalReed City, Michigan  49677