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
• Start date: June 2008

Study information

• Verified date: August 2023
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• 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. 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)

Related Conditions & MeSH terms

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

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