Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003861

Purpose

RATIONALE: Determination of genetic markers for acute lymphoblastic leukemia and acute promyelocytic leukemia may help identify patients with this disease and help predict the outcome of treatment.

PURPOSE: Diagnostic study of genetic markers in adult patients who have acute lymphoblastic leukemia or acute promyelocytic leukemia.

Condition	Intervention
Leukemia	Genetic: reverse transcriptase-polymerase chain reaction Other: flow cytometry

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Molecular Genetic Features of Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Association of novel genes or micorRNAs with other biomarkers [ Designated as safety issue: No ]
Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL [ Designated as safety issue: No ]
Clinical significance of MRD as defined by W T-1 [ Designated as safety issue: No ]
Blood and bone marrow specimen comparison on the quantitative measurement of MRD [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	April 1999

Detailed Description:

OBJECTIVES:

Perform quantitative polymerase chain reaction (PCR) using known leukemia specific markers in diagnostic bone marrow specimens and correlate pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcomes of patients with previously untreated acute lymphoblastic leukemia (ALL) or acute promyelocytic leukemia (APL).
Evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of these patients and correlate these findings with other biological features and treatment outcome.
Evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment and correlate these findings with efficacy of novel treatment approaches and other biological and clinical prognostic features.
Compare the measurement of MRD in blood with bone marrow specimens in sequential remission specimens.

OUTLINE: Blood and bone marrow samples are collected from patients periodically.

Samples are examined for the p190 and p210 BCR-ABL and WT-1 transcripts using reverse transcriptase-polymerase chain reaction (RT-PCR) analysis of the DNA and for marginal residual disease (MRD) via flow cytometric analysis.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study over 5 years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003861

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Locations

United States, California
Naval Medical Center - San Diego	Recruiting
San Diego, California, United States, 92134
Contact: Preston S. Gable, MD, FACP 619-532-7319
UCSF Helen Diller Family Comprehensive Cancer Center	Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222
United States, Delaware
CCOP - Christiana Care Health Services	Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227
Tunnell Cancer Center at Beebe Medical Center	Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171
United States, District of Columbia
Walter Reed Army Medical Center	Recruiting
Washington, District of Columbia, United States, 20307-5001
Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840
United States, Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando	Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623
United States, Illinois
BroMenn Regional Medical Center	Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD 309-243-3605
Cancer Treatment Center at Pekin Hospital	Recruiting
Pekin, Illinois, United States, 61554
Contact: John W. Kugler, MD 309-243-3605
Illinois Valley Community Hospital	Recruiting
Peru, Illinois, United States, 61354
Contact: John W. Kugler, MD 309-243-3605
Community Cancer Center	Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD 309-243-3605
Community Hospital of Ottawa	Recruiting
Ottawa, Illinois, United States, 61350
Contact: John W. Kugler, MD 309-243-3605
Eureka Community Hospital	Recruiting
Eureka, Illinois, United States, 61530
Contact: John W. Kugler, MD 309-243-3605
Galesburg Clinic, PC	Recruiting
Galesburg, Illinois, United States, 61401
Contact: John W. Kugler, MD 309-243-3605
Galesburg Cottage Hospital	Recruiting
Galesburg, Illinois, United States, 61401
Contact: John W. Kugler, MD 309-243-3605
Graham Hospital	Recruiting
Canton, Illinois, United States, 61520
Contact: John W. Kugler, MD 309-243-3605
CCOP - Illinois Oncology Research Association	Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler, MD 309-243-3605
Mason District Hospital	Recruiting
Havana, Illinois, United States, 62644
Contact: John W. Kugler, MD 309-243-3605
McDonough District Hospital	Recruiting
Macomb, Illinois, United States, 61455
Contact: John W. Kugler, MD 309-243-3605
Memorial Hospital	Recruiting
Carthage, Illinois, United States, 62321
Contact: John W. Kugler, MD 309-243-3605
Methodist Medical Center of Illinois	Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois 309-243-3000
Oncology Hematology Associates of Central Illinois, PC - Ottawa	Recruiting
Ottawa, Illinois, United States, 61350
Contact: John W. Kugler, MD 309-243-3605
St. Joseph Medical Center	Recruiting
Bloomington, Illinois, United States, 61701
Contact: John W. Kugler, MD 309-243-3605
OSF St. Francis Medical Center	Recruiting
Peoria, Illinois, United States, 61637
Contact: John W. Kugler, MD 309-243-3605
Proctor Hospital	Recruiting
Peoria, Illinois, United States, 61614
Contact: John W. Kugler, MD 309-243-3605
Oncology Hematology Associates of Central Illinois, PC - Peoria	Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler, MD 309-243-3605
St. Margaret's Hospital	Recruiting
Spring Valley, Illinois, United States, 61362
Contact: John W. Kugler, MD 309-243-3605
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
University of Illinois Cancer Center	Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046
United States, Indiana
Fort Wayne Medical Oncology and Hematology	Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Sreenivasa R. Nattam, MD 260-484-8830
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service 800-237-1225
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center	Recruiting
Bangor, Maine, United States, 04401
Contact: Clinical Trials Office - CancerCare of Maine 207-973-4274
Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Recruiting
Scarborough, Maine, United States, 04074
Contact: Helen F. Ryan 207-885-7600
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823
Union Hospital Cancer Program at Union Hospital	Recruiting
Elkton Md, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD 302-366-1200
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Trials Office 617-724-5200
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Richard M. Stone, MD 617-632-2214
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130
United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia	Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center 573-882-7440
Missouri Cancer Associates	Recruiting
Columbia, Missouri, United States, 65201
Contact: Clinical Trials Office - Missouri Cancer Associates 866-724-2413 research@missouricancer.com
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Geoffrey L. Uy 314-747-7222
United States, Nevada
CCOP - Nevada Cancer Research Foundation	Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM 702-384-0013
University Medical Center of Southern Nevada	Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM 702-384-0013
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees	Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757
United States, New York
CCOP - Hematology-Oncology Associates of Central New York	Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD 315-472-7504
Monter Cancer Center of the North Shore-LIJ Health System	Recruiting
Lake Success, New York, United States, 11042
Contact: Jonathan E. Kolitz, MD 516-562-8970
Don Monti Comprehensive Cancer Center at North Shore University Hospital	Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900
Long Island Jewish Medical Center	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jonathan E. Kolitz, MD 516-562-8970
CCOP - North Shore University Hospital	Recruiting
Manhasset, New York, United States, 11030
Contact: Jonathan E. Kolitz, MD 516-562-8970
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Lewis R. Silverman, MD 212-241-5520
New York Weill Cornell Cancer Center at Cornell University	Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724
SUNY Upstate Medical University Hospital	Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476
Veterans Affairs Medical Center - Syracuse	Recruiting
Syracuse, New York, United States, 13210
Contact: Leslie M. Howard, MD 315-425-3456
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432
Kinston Medical Specialists	Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD 252-559-2200ext.201
Leo W. Jenkins Cancer Center at ECU Medical School	Recruiting
Greenville, North Carolina, United States, 27834
Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M 252-744-2391
Duke Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771
Wayne Memorial Hospital, Incorporated	Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD 919-580-0000
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15224-1791
Contact: John Lister 412-578-5000
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus	Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990
Mountainview Medical	Recruiting
Berlin, Vermont, United States, 05602
Contact: Barbara W. Grant, MD 802-847-8400
United States, Virginia
Virginia Commonwealth University Massey Cancer Center	Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Wendy Stock, MD

University of Chicago

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Study ID Numbers:	CDR0000067025, CALGB-9862
Study First Received:	November 1, 1999
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00003861 History of Changes
Health Authority:	Unspecified