Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Multiple Myeloma - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00048958

Purpose

RATIONALE: Cytogenetic tests may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.

PURPOSE: This diagnostic trial is studying genetic differences in patients with treated and untreated acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or multiple myeloma.

Condition	Intervention
Leukemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Genetic: chromosomal translocation analysis Genetic: cytogenetic analysis

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Cytogenetic Studies For Previously Untreated AML, ALL or MDS Patients (Companion To CALGB Treatment Studies For Previously Untreated AML, ALL Or MDS Patients)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Multiple Myeloma

U.S. FDA Resources

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

Estimated Enrollment:	6400
Study Start Date:	June 1984
Estimated Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the incidence of chromosomal abnormalities in patients with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or multiple myeloma.
Correlate specific chromosomal abnormalities with clinical and laboratory parameters in these patients.
Correlate specific karyotype groups with treatment response rates, response duration, survival, and cure in patients treated with various induction and post-induction regimens.
Correlate specific karyotype groups with multidrug resistance data in these patients.
Identify new chromosome abnormalities important in leukemogenesis.
Correlate specific karyotype groups with epidemiological data (toxic exposure and family history) in these patients.
Determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse in subsequent clinical courses in these patients.
Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols.

OUTLINE: This is a multicenter study.

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.

PROJECTED ACCRUAL: Approximately 6,400 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Must enroll (within 1 month of registration on this study) on a CALGB treatment study for previously untreated acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes
Patients enrolled on CLB-100001 (previously treated or untreated multiple myeloma) must enroll on this study
Simultaneous registration on CLB-9665 (within the continental United States)

PATIENT CHARACTERISTICS:

Age

15 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048958

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Locations

United States, Alabama
UAB Comprehensive Cancer Center	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309
United States, California
Camino Medical Group - Treatment Center	Recruiting
Mountain View, California, United States, 94040
Contact: Peter P. Yu, MD 408-524-5814
Kaiser Permanente Medical Office -Vandever Medical Office	Recruiting
San Diego, California, United States, 92120
Contact: Han A. Koh 619-528-2596
Rebecca and John Moores UCSD Cancer Center	Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu
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
CCOP - Mount Sinai Medical Center	Recruiting
Miami Beach, Florida, United States, 33140
Contact: Rogerio C. Lilenbaum, MD 305-535-3310
Cleveland Clinic Florida - Weston	Recruiting
Weston, Florida, United States, 33331
Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston 954-659-5705
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi 954-776-3239
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
Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center 561-745-5768
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
CCOP - Illinois Oncology Research Association	Recruiting
Peoria, Illinois, United States, 61615
Contact: John W. Kugler, MD 309-243-3605
Center for Cancer Care at OSF Saint Anthony Medical Center	Recruiting
Rockford, Illinois, United States, 61108
Contact: Clinical Trials Office - Center for Cancer Care at OSF Saint 815-227-2633
Community Cancer Center	Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Princeton	Recruiting
Princeton, Illinois, United States, 61356
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
Evanston Hospital	Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Hospital 847-570-1381
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
Illinois CancerCare - Bloomington	Recruiting
Bloomington%, Illinois, United States, 61701
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Canton	Recruiting
Canton, Illinois, United States, 61520
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Carthage	Recruiting
Carthage, Illinois, United States, 62321
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Community Cancer Center	Recruiting
Normal, Illinois, United States, 61761
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Eureka	Recruiting
Eureka, Illinois, United States, 61530
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Galesburg	Recruiting
Galesburg, Illinois, United States, 61401
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Havana	Recruiting
Havana, Illinois, United States, 62644
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Kewanee Clinic	Recruiting
Kewanee, Illinois, United States, 61443
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Macomb	Recruiting
Macomb, Illinois, United States, 61455
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Monmouth	Recruiting
Monmouth, Illinois, United States, 61462
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Pekin	Recruiting
Pekin, Illinois, United States, 61603
Contact: John W. Kugler, MD 309-243-3605
Illinois CancerCare - Peru	Recruiting
Peru, Illinois, United States, 61354
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
Illinois CancerCare - Spring Valley	Recruiting
Spring Valley, Illinois, United States, 61362
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
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
OSF St. Francis Medical Center	Recruiting
Peoria, Illinois, United States, 61637
Contact: John W. Kugler, MD 309-243-3605
Oncology Hematology Associates of Central Illinois, PC - Ottawa	Recruiting
Ottawa, Illinois, United States, 61350
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
OSF Holy Family Medical Center	Recruiting
Monmouth, Illinois, United States, 61462
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
Proctor Hospital	Recruiting
Peoria, Illinois, United States, 61614
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
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
Hematology Oncology Associates of the Quad Cities	Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Shobha R. Chitneni, MD, MBBS 563-355-7733
Holden Comprehensive Cancer Center at University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service 800-237-1225
Iowa Blood and Cancer Care	Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: David O. Zenk, MD 319-369-7091
Mercy Regional Cancer Center at Mercy Medical Center	Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: David O. Zenk, MD 319-369-7091
St. Luke's Hospital	Recruiting
Cedar Rapids, Iowa, United States, 52402
Contact: David O. Zenk, MD 319-369-7091
United States, Kansas
Menorah Medical Center	Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD 816-823-0555
Saint Luke's Hospital - South	Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur, MD 816-823-0555
Shawnee Mission Medical Center	Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Rakesh Gaur, MD 816-823-0555
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
Central Maine Comprehensive Cancer Center at Central Maine Medical Center	Recruiting
Lewiston, Maine, United States, 04240
Contact: Ann E. Traynor 207-795-2440
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
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center	Recruiting
Baltimore, Maryland, United States, 21237
Contact: Clinical Trials Office - Harry & Jeanette Weinberg Cancer Inst 443-777-7364
Union Hospital Cancer Program at Union Hospital	Recruiting
Elkton Md, Maryland, United States, 21921
Contact: Frank Beardell, MD 302-737-7700
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, Michigan
Lacks Cancer Center at Saint Mary's Health Care	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury 616-752-5222
Butterworth Hospital at Spectrum Health	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury 616-391-2799
CCOP - Grand Rapids	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Martin J. Bury 616-391-1230
Battle Creek Health System Cancer Care Center	Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Martin J. Bury 616-966-8000
Mecosta County Medical Center	Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Martin J. Bury 231-796-8691
Mercy General Health Partners	Recruiting
Muskegon, Michigan, United States, 49443
Contact: Martin J. Bury 231-672-2000
Metro Health Hospital	Recruiting
Wyoming, Michigan, United States, 49519
Contact: Martin J. Bury 616-252-7200
Munson Medical Center	Recruiting
Traverse City, Michigan, United States, 49684
Contact: Martin J. Bury 231-935-6202
Oncology Care Associates, PLLC	Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Eric P. Lester, MD 269-985-0029
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
St. Luke's Hospital Cancer Care Center	Recruiting
Duluth, Minnesota, United States, 55805
Contact: Tanya L. Repka, MD, FACP 218-726-3081
Veterans Affairs Medical Center - Minneapolis	Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Min 612-467-2800
United States, Missouri
Arch Medical Services, Incorporated at Center for Cancer Care and Research	Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Alan P. Lyss, MD 314-996-5514
CCOP - Kansas City	Recruiting
Kansas City, Missouri, United States, 64131
Contact: Rakesh Gaur, MD 816-823-0555
Saint Luke's Cancer Institute at Saint Luke's Hospital	Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur, MD 816-823-0555
Heartland Regional Medical Center	Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur, MD 816-823-0555
Liberty Hospital	Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur, MD 816-823-0555
Missouri Baptist Cancer Center	Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD 314-996-5514
Missouri Cancer Associates	Recruiting
Columbia, Missouri, United States, 65201
Contact: Clinical Trials Office - Missouri Cancer Associates 866-724-2413 research@missouricancer.com
North Kansas City Hospital	Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD 816-823-0555
Parvin Radiation Oncology	Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD 816-823-0555
Research Medical Center	Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD 816-823-0555
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
Saint Luke's East - Lee's Summit	Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur, MD 816-823-0555
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD 314-362-5654
St. Joseph Medical Center	Recruiting
Kansas City, Missouri, United States, 64114
Contact: Rakesh Gaur, MD 816-823-0555
Truman Medical Center - Hospital Hill	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Rakesh Gaur, MD 816-823-0555
United States, Nebraska
Callahan Cancer Center at Great Plains Regional Medical Center	Recruiting
North Platte, Nebraska, United States, 69103
Contact: Clinical Trials Office - Callahan Cancer Center at Great Plain 308-696-7864
Methodist Estabrook Cancer Center	Recruiting
Omaha, Nebraska, United States, 68114
Contact: Robert M. Langdon, MD 402-399-8762
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center	Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Lori J. Maness, MD 402-559-5520
UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465
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
CCOP - North Shore University Hospital	Recruiting
Manhasset, New York, United States, 11030
Contact: Vincent P. Vinciguerra, MD 516-734-8954
Charles R. Wood Cancer Center at Glens Falls Hospital	Recruiting
Glens Falls, New York, United States, 12801
Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen 518-926-6700
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Lewis R. Silverman, MD 212-241-5520
Long Island Jewish Medical Center	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Kanti R. Rai, MD 718-470-7135
Monter Cancer Center of the North Shore-LIJ Health System	Recruiting
Lake Success, New York, United States, 11042
Contact: Vincent P. Vinciguerra, MD 516-734-8954
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
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
Queens Cancer Center of Queens Hospital	Recruiting
Jamaica, New York, United States, 11432
Contact: Lewis R. Silverman, MD 212-241-5520
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724
Stony Brook University Cancer Center	Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215
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: Jane M. Hudson 315-425-4400
United States, North Carolina
Batte Cancer Center at Northeast Medical Center	Recruiting
Concord, North Carolina, United States, 28025
Contact: James G. Wall, MD 704-783-1370
Blumenthal Cancer Center at Carolinas Medical Center	Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884
CaroMont Cancer Center at Gaston Memorial Hospital	Recruiting
Gastonia, North Carolina, United States, 28053
Contact: Clinical Trials Office - CaroMont Cancer Center at Gaston Memo 704-834-2932
Duke Comprehensive Cancer Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853
Pardee Memorial Hospital	Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford, MD 828-692-8045
Forsyth Regional Cancer Center at Forsyth Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Clinical Trials Office - Forsyth Regional Cancer Center at For 336-277-8887
Granville Medical Center	Recruiting
Oxford, North Carolina, United States, 27565
Contact: Jeffrey Crawford, MD 919-681-9509
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
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
Maria Parham Medical Center	Recruiting
Henderson, North Carolina, United States, 27536
Contact: Jeffrey Crawford, MD 919-681-9509
Mission Hospitals - Memorial Campus	Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150
Duke Health Raleigh Hospital	Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Jeffrey Crawford, MD 919-681-9509
Person Memorial Hospital	Recruiting
Roxboro, North Carolina, United States, 27573
Contact: Jeffrey Crawford, MD 919-681-9509
Presbyterian Cancer Center at Presbyterian Hospital	Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369
Southeastern Regional Medical Center	Recruiting
Lumberton, North Carolina, United States, 28359
Contact: Jeffrey Crawford, MD 919-681-9509
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, Oklahoma
Cancer Care Associates - Mercy Campus	Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Howard Ozer, MD, PhD 405-271-4022
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Howard Ozer, MD, PhD 405-271-4022
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
Memorial Hospital of Rhode Island	Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Humera Khurshid 401-729-2000
Miriam Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Clinical Trials Office - Miriam Hospital 401-793-2224
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, South Carolina
CCOP - Greenville	Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere, MD, FACP 864-987-7000
McLeod Regional Medical Center	Recruiting
Florence, South Carolina, United States, 29501
Contact: Clinical Trials Office - McLeod Regional Medical Center 843-679-7256
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
Danville Regional Medical Center	Recruiting
Danville, Virginia, United States, 24541
Contact: Clinical Trials Office - Danville Regional Medical Center 434-799-3753
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:

Clara D. Bloomfield, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Farag SS, Archer KJ, Mrozek K, Ruppert AS, Carroll AJ, Vardiman JW, Pettenati MJ, Baer MR, Qumsiyeh MB, Koduru PR, Ning Y, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Pretreatment cytogenetics add to other prognostic factors predicting complete remission and long-term outcome in patients 60 years of age or older with acute myeloid leukemia: results from cancer and leukemia group B 8461. Blood. 2006 Mar 7; [Epub ahead of print]

Farag SS, Ruppert AS, Mrozek K, Mayer RJ, Stone RM, Carroll AJ, Powell BL, Moore JO, Pettenati MJ, Koduru PR, Stamberg J, Baer MR, Block AW, Vardiman JW, Kolitz JE, Schiffer CA, Larson RA, Bloomfield CD. Outcome of induction and postremission therapy in younger adults with acute myeloid leukemia with normal karyotype: a cancer and leukemia group B study. J Clin Oncol. 2005 Jan 20;23(3):482-93. Epub 2004 Nov 8.

Bloomfield CD, Ruppert AS, Mrozek K, Kolitz JE, Moore JO, Mayer RJ, Edwards CG, Sterling LJ, Vardiman JW, Carroll AJ, Pettenati MJ, Stamberg J, Byrd JC, Marcucci G, Larson RA; Cancer and Leukemia Group B (CALGB) Study 8461. Core binding factor acute myeloid leukemia. Cancer and Leukemia Group B (CALGB) Study 8461. Ann Hematol. 2004;83 Suppl 1:S84-5. No abstract available.

Blum W, Mrozek K, Ruppert AS, et al.: Early allogeneic transplantation for adults with de novo acute myeloid leukemia presenting with t(6;11)(q27;q23): results from CALGB 8461. [Abstract] J Clin Oncol 22 (Suppl 14): A-6543, 568s, 2004.

Blum W, Mrozek K, Ruppert AS, Carroll AJ, Rao KW, Pettenati MJ, Anastasi J, Larson RA, Bloomfield CD. Adult de novo acute myeloid leukemia with t(6;11)(q27;q23): results from Cancer and Leukemia Group B Study 8461 and review of the literature. Cancer. 2004 Sep 15;101(6):1420-7. Review.

Byrd JC, Ruppert AS, Mrozek K, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Stamberg J, Koduru PR, Moore JO, Mayer RJ, Davey FR, Larson RA, Bloomfield CD. Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(16)(p13q22) or t(16;16)(p13;q22): results from CALGB 8461. J Clin Oncol. 2004 Mar 15;22(6):1087-94.

Farag SS, Archer KJ, Mrózek K, et al.: Pre-treatment cytogenetics predict complete remission and long-term outcome in patients (Pts) ≥60 years with acute myeloid leukemia (AML): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 104 (11): A-568, 2004.

Marcucci G, Mrózek, K, Ruppert AS, et al.: t(8;21) Acute myeloid leukemia (AML) differs from inv(16) AML in pretreatment characteristics, outcome and prognostic factors predicting outcome: a Cancer and Leukemia Group B (CALGB) Study. [Abstract] Blood 104 (11): A-2017, 2004.

Marcucci G, Mrózek K, Ruppert AS, et al.: Association of abnormal cytogenetics at date of morphologic complete remission (CR) with overall (OS), disease-free survival (DFS) and higher relapse rate in acute myeloid leukemia (AML): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] J Clin Oncol 22 (Suppl 14): A-6514, 561s, 2004.

Marcucci G, Mrozek K, Ruppert AS, Archer KJ, Pettenati MJ, Heerema NA, Carroll AJ, Koduru PR, Kolitz JE, Sterling LJ, Edwards CG, Anastasi J, Larson RA, Bloomfield CD. Abnormal cytogenetics at date of morphologic complete remission predicts short overall and disease-free survival, and higher relapse rate in adult acute myeloid leukemia: results from cancer and leukemia group B study 8461. J Clin Oncol. 2004 Jun 15;22(12):2410-8.

Slovak ML, Bloomfield CD, Gundacker H, et al.: Acute myeloid leukemia (AML) with t(6;9)(p23;q34) defines a very poor risk leukemia subgroup with distinguishing clinicopathological features: a United States (US) Cytogenetics Intergroup Study of 62 AML and MDS cases. [Abstract] Blood 104 (11): A-567, 2004.

Byrd JC, Mrozek K, Dodge RK, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Patil SR, Rao KW, Watson MS, Koduru PR, Moore JO, Stone RM, Mayer RJ, Feldman EJ, Davey FR, Schiffer CA, Larson RA, Bloomfield CD. Pretreatment cytogenetic abnormalities are predictive of induction success, cumulative incidence of relapse, and overall survival in adult patients with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B (CALGB 8461). Blood. 2002 Dec 15;100(13):4325-36.

Farag SS, Archer KJ, Mrozek K, Vardiman JW, Carroll AJ, Pettenati MJ, Moore JO, Kolitz JE, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Isolated trisomy of chromosomes 8, 11, 13 and 21 is an adverse prognostic factor in adults with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B 8461. Int J Oncol. 2002 Nov;21(5):1041-51.

Bloomfield CD, Byrd JC, Farag SS, et al.: Cytogenetics for treatment stratification in adult acute myeloid leukemia (AML). [Abstract] Ann Hematol 80 (Suppl 2): A-37, S10, 2001.

Byrd JC, Mrózek K, Dodge R, et al.: Pre-treatment cytogenetics predict initial induction success and overall survival in adult patients with de novo acute myeloid leukemia: results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-1912, 457a, 2001.

Farag SS, Archer KJ, Carroll AJ, et al.: Isolated trisomy (IT) is an adverse prognostic factor in patients (pts) with AML: results from Cancer and Leukemia Group B (CALGB 8461). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1124, 2001.

Marcucci G, Archer KJ, Mrózek K, et al.: Abnormal karyotype during complete remission (CR) predicts short relapse-free survival (RFS) in acute myeloid leukemia (AML): results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-2421, 577a, 2001.

Wetzler M, Dodge RK, Mrozek K, et al.: Secondary chromosome aberrations in adult acute lymphoblastic leukemia (ALL) with t(9;22) - a Cancer and Leukemia Group B (CALGB) study. [Abstract] Blood 98 (11 Pt 1): A-466, 111a, 2001.

Wetzler M, Dodge RK, Mrózek K, et al.: Karyotype change in adult acute myeloid leukemia (AML) at first relapse - CALGB 8461. [Abstract] Blood 96 (11 Pt 1): A-3046, 706a, 2000.

Bloomfield D: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Ann Hematol 78 (Suppl 2): A-50, S13, 1999.

Byrd JC, Dodge RK, Carroll A, Baer MR, Edwards C, Stamberg J, Qumsiyeh M, Moore JO, Mayer RJ, Davey F, Schiffer CA, Bloomfield CD. Patients with t(8;21)(q22;q22) and acute myeloid leukemia have superior failure-free and overall survival when repetitive cycles of high-dose cytarabine are administered. J Clin Oncol. 1999 Dec;17(12):3767-75.

Wetzler M, Dodge RK, Mrozek K, Carroll AJ, Tantravahi R, Block AW, Pettenati MJ, Le Beau MM, Frankel SR, Stewart CC, Szatrowski TP, Schiffer CA, Larson RA, Bloomfield CD. Prospective karyotype analysis in adult acute lymphoblastic leukemia: the cancer and leukemia Group B experience. Blood. 1999 Jun 1;93(11):3983-93.

Baer MR, Stewart CC, Lawrence D, Arthur DC, Mrozek K, Strout MP, Davey FR, Schiffer CA, Bloomfield CD. Acute myeloid leukemia with 11q23 translocations: myelomonocytic immunophenotype by multiparameter flow cytometry. Leukemia. 1998 Mar;12(3):317-25.

Bloomfield CD, Lawrence D, Byrd JC, Carroll A, Pettenati MJ, Tantravahi R, Patil SR, Davey FR, Berg DT, Schiffer CA, Arthur DC, Mayer RJ. Frequency of prolonged remission duration after high-dose cytarabine intensification in acute myeloid leukemia varies by cytogenetic subtype. Cancer Res. 1998 Sep 15;58(18):4173-9.

Byrd JC, Dodge R, Carroll A, et al.: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Blood 92 (10 Pt 1): A-1282, 312a, 1998.

Byrd JC, Lawrence D, Arthur DC, Pettenati MJ, Tantravahi R, Qumsiyeh M, Stamberg J, Davey FR, Schiffer CA, Bloomfield CD. Patients with isolated trisomy 8 in acute myeloid leukemia are not cured with cytarabine-based chemotherapy: results from Cancer and Leukemia Group B 8461. Clin Cancer Res. 1998 May;4(5):1235-41.

Caligiuri MA, Strout MP, Lawrence D, Arthur DC, Baer MR, Yu F, Knuutila S, Mrozek K, Oberkircher AR, Marcucci G, de la Chapelle A, Elonen E, Block AW, Rao PN, Herzig GP, Powell BL, Ruutu T, Schiffer CA, Bloomfield CD. Rearrangement of ALL1 (MLL) in acute myeloid leukemia with normal cytogenetics. Cancer Res. 1998 Jan 1;58(1):55-9.

Heinonen K, Mrozek K, Lawrence D, Arthur DC, Pettenati MJ, Stamberg J, Qumsiyeh MB, Verma RS, MacCallum J, Schiffer CA, Bloomfield CD. Clinical characteristics of patients with de novo acute myeloid leukaemia and isolated trisomy 11: a Cancer and Leukemia Group B study. Br J Haematol. 1998 Jun;101(3):513-20.

Wetzler M, Dodge RK, Mrózek K, et al.: Trisomy 8 represents a poor risk group in adult acute lymphoblastic leukemia (ALL): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 92 (10 Pt 1): A-914, 223a, 1998.

Byrd JC, Weiss RB, Arthur DC, Lawrence D, Baer MR, Davey F, Trikha ES, Carroll AJ, Tantravahi R, Qumsiyeh M, Patil SR, Moore JO, Mayer RJ, Schiffer CA, Bloomfield CD. Extramedullary leukemia adversely affects hematologic complete remission rate and overall survival in patients with t(8;21)(q22;q22): results from Cancer and Leukemia Group B 8461. J Clin Oncol. 1997 Feb;15(2):466-75.

Mrózek K, Heinonen K, Lawrence D, et al.: t(9;11)(p22;q23) confers better prognosis than other translocations of 11q23 in adults with de novo acute myeloid leukemia (AML): a Cancer and Leukemia Group B study. [Abstract] Cytogenet Cell Genet 77: A-P332, 136, 1997.

Mrozek K, Heinonen K, Lawrence D, Carroll AJ, Koduru PR, Rao KW, Strout MP, Hutchison RE, Moore JO, Mayer RJ, Schiffer CA, Bloomfield CD. Adult patients with de novo acute myeloid leukemia and t(9; 11)(p22; q23) have a superior outcome to patients with other translocations involving band 11q23: a cancer and leukemia group B study. Blood. 1997 Dec 1;90(11):4532-8.

Bernstein SH, Brunetto VL, Davey FR, Wurster-Hill D, Mayer RJ, Stone RM, Schiffer CA, Bloomfield CD. Acute myeloid leukemia-type chemotherapy for newly diagnosed patients without antecedent cytopenias having myelodysplastic syndrome as defined by French-American-British criteria: a Cancer and Leukemia Group B Study. J Clin Oncol. 1996 Sep;14(9):2486-94.

Byrd JC, Lawrence D, Arthur DC, et al.: Acute myeloid leukemia (AML) patients with pre-treatment isolated trisomy 8 are rarely cured with chemotherapy: results of CALGB 8461. [Abstract] Proc Am Assoc Cancer Res 37: A-1286, 188, 1996.

Caligiuri MA, Strout MP, Arthur DC, et al.: Rearrangement of ALL1 is a recurrent molecular defect in adult acute myeloid leukemia (AML) with normal cytogenetics that predicts a short complete remission (CR) duration. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A-1060, 1996.

Chen H, Sandler DP, Taylor JA, Shore DL, Liu E, Bloomfield CD, Bell DA. Increased risk for myelodysplastic syndromes in individuals with glutathione transferase theta 1 (GSTT1) gene defect. Lancet. 1996 Feb 3;347(8997):295-7.

Heinonen K, Mrózek K, Lawrence D, et al.: Trisomy 11 as the sole karyotypic abnormality identifies a group of older patients with acute myeloid leukemia (AML) with FAB M2 or M1 and unfavorable clinical outcome. Results of CALGB 8461. [Abstract] Proc Am Assoc Cancer Res 37: A-1275, 186-7, 1996.

Slack JL, Arthur DC, Lawrence D, et al.: Secondary (2°) cytogenetic changes in acute promyelocytic leukemia (APL): prognostic importance and association with the intron 3 breakpoint of the PML gene. [Abstract] Proc Am Assoc Cancer Res 37: A-3815, 557, 1996.

Marcucci G, Mrozek K, Ruppert AS, Maharry K, Kolitz JE, Moore JO, Mayer RJ, Pettenati MJ, Powell BL, Edwards CG, Sterling LJ, Vardiman JW, Schiffer CA, Carroll AJ, Larson RA, Bloomfield CD. Prognostic factors and outcome of core binding factor acute myeloid leukemia patients with t(8;21) differ from those of patients with inv(16): a Cancer and Leukemia Group B study. J Clin Oncol. 2005 Aug 20;23(24):5705-17.

Mrozek K, Carroll AJ, Maharry K, et al.: Central review of cytogenetics is essential for cooperative group clinical and correlative studies of acute leukemia: The Cancer and Leukemia Group B (CALGB) 8461 experience. [Abstract] Blood 104 (11): A-1081, 2004.

Sekeres MA, Peterson B, Dodge RK, Mayer RJ, Moore JO, Lee EJ, Kolitz J, Baer MR, Schiffer CA, Carroll AJ, Vardiman JW, Davey FR, Bloomfield CD, Larson RA, Stone RM; Cancer and Leukemia Group B. Differences in prognostic factors and outcomes in African Americans and whites with acute myeloid leukemia. Blood. 2004 Jun 1;103(11):4036-42. Epub 2004 Feb 19.

Baldus CD, Tanner SM, Ruppert AS, Whitman SP, Archer KJ, Marcucci G, Caligiuri MA, Carroll AJ, Vardiman JW, Powell BL, Allen SL, Moore JO, Larson RA, Kolitz JE, de la Chapelle A, Bloomfield CD. BAALC expression predicts clinical outcome of de novo acute myeloid leukemia patients with normal cytogenetics: a Cancer and Leukemia Group B Study. Blood. 2003 Sep 1;102(5):1613-8. Epub 2003 May 15.

Heinonen K, Rao PN, Slack JL, Cruz J, Bloomfield CD, Mrozek K. Isochromosome 12p in two cases of acute myeloid leukaemia without evidence of germ cell tumour. Br J Haematol. 1996 Jun;93(3):677-80.

Study ID Numbers:	CDR0000256897, CALGB-8461
Study First Received:	November 12, 2002
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00048958 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
untreated childhood acute lymphoblastic leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
myelodysplastic/myeloproliferative disease, unclassifiable

multiple myeloma
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)
childhood myelodysplastic syndromes

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precancerous Conditions
Blood Protein Disorders
Paraproteinemias
Leukemia, Myeloid, Acute
Hemostatic Disorders
Leukemia
Preleukemia
Pathologic Processes
Hemorrhagic Disorders
Syndrome
Cardiovascular Diseases
Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type

Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Leukemia, Myeloid
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 25, 2009