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NCT00900224 Clinical Trial

Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
Assessment of Novel Molecular Markers in Acute Myeloid Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00900224
Other study ID # CALGB-20202
Secondary ID CALGB-20202CDR00
Status Active, not recruiting
Phase
First received
Last updated
Start date June 2008

Study information
Verified date August 2023
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 529
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• DNA methylation analysis

• gene expression analysis

• mutation analysis

• polymerase chain reaction

• reverse transcriptase-polymerase chain reaction

Other:
• high performance liquid chromatography

• laboratory biomarker analysis

Locations
Country Name City State
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Battle Creek Health System Cancer Care Center Battle Creek Michigan
United States Mountainview Medical Berlin Vermont
United States Mecosta County Medical Center Big Rapids Michigan
United States Illinois CancerCare - Bloomington Bloomington Illinois
United States St. Joseph Medical Center Bloomington Illinois
United States Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts
United States Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Illinois CancerCare - Canton Canton Illinois
United States Illinois CancerCare - Carthage Carthage Illinois
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Union Hospital of Cecil County Elkton Maryland
United States Eureka Community Hospital Eureka Illinois
United States Illinois CancerCare - Eureka Eureka Illinois
United States Evanston Hospital Evanston Illinois
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Galesburg Clinic, PC Galesburg Illinois
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Butterworth Hospital at Spectrum Health Grand Rapids Michigan
United States CCOP - Grand Rapids Grand Rapids Michigan
United States Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Illinois CancerCare - Havana Havana Illinois
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Illinois CancerCare - Kewanee Clinic Kewanee Illinois
United States Kinston Medical Specialists Kinston North Carolina
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Illinois CancerCare - Macomb Macomb Illinois
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Illinois CancerCare - Monmouth Monmouth Illinois
United States OSF Holy Family Medical Center Monmouth Illinois
United States Camino Medical Group - Treatment Center Mountain View California
United States Mercy General Health Partners Muskegon Michigan
United States Long Island Jewish Medical Center New Hyde Park New York
United States Mount Sinai Medical Center New York New York
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Illinois CancerCare - Community Cancer Center Normal Illinois
United States Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States Illinois CancerCare - Pekin Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare - Peru Peru Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Illinois CancerCare - Princeton Princeton Illinois
United States Spectrum Health Reed City Hospital Reed City Michigan
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Illinois CancerCare - Spring Valley Spring Valley Illinois
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Munson Medical Center Traverse City Michigan
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 W — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of molecular markers that fulfill eligibility criteria in diagnostic samples from AML patients considered for CALGB therapeutic protocols baseline
Primary Frequency of specific single-gene markers over-expression and levels of promoter methylation of specific genes baseline
Primary Predictive value of specific single-gene markers baseline
Primary Microarray multi-gene and multi-miR expression signatures baseline
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