Genetic Study of Patients with Previously Untreated Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Multiple Myeloma

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedBiomarker/Laboratory analysis, Natural history/Epidemiology15 and overCALGB 8461
NCI-2009-00494, CDR0000256897, NCT00048958

Trial Description

Summary

This research trial studies genetic differences in patients with treated and untreated acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or multiple myeloma. Cytogenetic tests may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), as well as multiple myeloma.

II. To correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

III. To correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens.

IV. To correlate specific karyotype groups with selected molecular abnormalities as studied in Cancer and Leukemia Group B (CALGB) leukemia protocols.

V. To correlate specific karyotype groups with multidrug resistance data.

VI. To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history).

VII. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course.

VIII. To identify new chromosome abnormalities important in leukemogenesis.

OUTLINE:

Patients undergo collection of bone marrow and blood specimens for cytogenetic analysis at diagnosis, complete remission, and relapse. Specimens are karyotyped and examined for chromosomal abnormalities.

Eligibility Criteria

Inclusion Criteria:

Only patients from Alliance institutions enrolling on treatment study CALGB 10701 are eligible for enrollment on this study

Within one month of registration on 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients

Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Alliance for Clinical Trials in Oncology

  • National Cancer Institute
Clara Derber Bloomfield, Principal Investigator

Trial Sites

U.S.A.

California
San Diego

Naval Medical Center -San Diego

Preston S. Gable
Ph: 619-532-8712

Preston S. Gable
Principal Investigator

San Francisco

UCSF Medical Center-Mount Zion

Lloyd Earl Damon
Ph: 877-827-3222

Lloyd Earl Damon
Principal Investigator

Delaware
Newark

Christiana Care Health System-Christiana Hospital

Frank V. Beardell
Ph: 302-733-6227

Frank V. Beardell
Principal Investigator

Illinois
Chicago

University of Chicago Comprehensive Cancer Center

Richard A. Larson
Ph: 773-834-7424

Richard A. Larson
Principal Investigator

University of Illinois

David J. Peace
Ph: 312-355-3046

David J. Peace
Principal Investigator

Indiana
Fort Wayne

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Sreenivasa R. Nattam
Ph: 260-484-8830
Email: ledgar@fwmoh.com

Sreenivasa R. Nattam
Principal Investigator

Merrillville

Premier Oncology Hematology Associates

Bharat H. Barai
Ph: 219-736-2800

Bharat H. Barai
Principal Investigator

Iowa
Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Daniel Alberto Vaena
Ph: 800-237-1225

Daniel Alberto Vaena
Principal Investigator

Maine
Augusta

Harold Alfond Center for Cancer Care

Thomas H. Openshaw
Ph: 207-973-4274

Thomas H. Openshaw
Principal Investigator

Bangor

Eastern Maine Medical Center

Thomas H. Openshaw
Ph: 207-973-4274

Thomas H. Openshaw
Principal Investigator

Maryland
Baltimore

University of Maryland/Greenebaum Cancer Center

Maria R. Baer
Ph: 800-888-8823

Maria R. Baer
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Richard M. Stone
Ph: 877-442-3324

Richard M. Stone
Principal Investigator

Massachusetts General Hospital Cancer Center

Richard M. Stone
Ph: 877-442-3324

Richard M. Stone
Principal Investigator

Michigan
Grand Rapids

Spectrum Health at Butterworth Campus

Gilbert D.A. Padula
Ph: 616-685-5225
Email: connie.szczepanek@grcop.org

Gilbert D.A. Padula
Principal Investigator

Minnesota
Minneapolis

Minneapolis Veterans Medical Center

Sharon Davis Luikart
Ph: 612-467-2800

Sharon Davis Luikart
Principal Investigator

University of Minnesota Medical Center-Fairview

Bruce Attree Peterson
Ph: 612-624-2620

Bruce Attree Peterson
Principal Investigator

Missouri
Columbia

Veterans Administration

Shadi M. Haddadin
Ph: 888-823-5923
Email: ctsucontact@westat.com

Shadi M. Haddadin
Principal Investigator

Saint Louis

Missouri Baptist Medical Center

James Lloyd Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

James Lloyd Wade
Principal Investigator

Nevada
Las Vegas

University Medical Center of Southern Nevada

John Allan Ellerton
Ph: 702-384-0013

John Allan Ellerton
Principal Investigator

New York
New York

Mount Sinai Medical Center

Lewis R. Silverman
Ph: 212-824-7320
Email: jenny.figueroa@mssm.edu

Lewis R. Silverman
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Teresa Caroline Gentile
Ph: 315-464-5476

Teresa Caroline Gentile
Principal Investigator

North Carolina
Durham

Duke University Medical Center

Jeffrey Crawford
Ph: 888-275-3853

Jeffrey Crawford
Principal Investigator

Greenville

East Carolina University

Paul Raymond Walker
Ph: 252-744-2161

Paul Raymond Walker
Principal Investigator

Kinston

Kinston Medical Specialists PA

Peter Robins Watson
Ph: 252-559-2200

Peter Robins Watson
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Bayard Lowery Powell
Ph: 336-713-6771

Bayard Lowery Powell
Principal Investigator

Ohio
Columbus

Ohio State University Comprehensive Cancer Center

Clara Derber Bloomfield
Ph: 800-293-5066
Email: Jamesline@osumc.edu

Clara Derber Bloomfield
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Mohamad Cherry
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Mohamad Cherry
Principal Investigator

Pennsylvania
Pittsburgh

West Penn Hospital

John Lister
Ph: 412-578-5000

John Lister
Principal Investigator

Rhode Island
Providence

Miriam Hospital

William Marshall Sikov
Ph: 401-274-1122

William Marshall Sikov
Principal Investigator

Rhode Island Hospital

William Marshall Sikov
Ph: 401-274-1122

William Marshall Sikov
Principal Investigator

Vermont
Burlington

University of Vermont College of Medicine

George Fuad Atweh
Ph: 802-656-4101

George Fuad Atweh
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00048958

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.