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Cytogenetic Studies in Acute Leukemia and Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00048958
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.

Condition or disease Intervention/treatment
Acute Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome Multiple Myeloma Genetic: cytogenetic analysis

Study Design

Study Type : Observational
Estimated Enrollment : 9000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients
Study Start Date : June 1984
Estimated Primary Completion Date : January 2100


Groups and Cohorts

Group/Cohort Intervention/treatment
No treatment
Samples as defined per the protocol for previously untreated patients with AML, ALL, MDS or MM will be submitted for analysis and within one month patients are required to register onto a CALGB treatment study.
Genetic: cytogenetic analysis


Outcome Measures

Primary Outcome Measures :
  1. Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM [ Time Frame: Up to 10 years ]
  2. Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters [ Time Frame: Up to 10 years ]
  3. Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens [ Time Frame: Up to 10 years ]
  4. Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols [ Time Frame: Up to 10 years ]
  5. To correlate specific karyotype groups with multidrug resistance data [ Time Frame: Up to 10 years ]
  6. To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) [ Time Frame: Up to 10 years ]
  7. 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 [ Time Frame: up to 10 yeras ]
  8. To identify new chromosome abnormalities important in leukemogenesis [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
Institutions must submit patient samples (eg, bone marrow and peripheral blood) at diagnosis, at complete remission, and at the time of relapse to the Alliance-Approved Institutional Cytogeneticist.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient population from the clinical oncology research community including academic institutions, hospitals and clinics.
Criteria
  1. Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct.
  2. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients.
  3. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048958


  Hide Study Locations
Locations
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Camino Medical Group - Treatment Center
Mountain View, California, United States, 94040
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92108
Naval Medical Center - San Diego
San Diego, California, United States, 92134
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20007
Washington Cancer Institute at Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States, 61701
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Illinois CancerCare - Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
McDonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States, 61462
OSF Holy Family Medical Center
Monmouth, Illinois, United States, 61462
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Illinois CancerCare - Pekin
Pekin, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare - Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States, 61362
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
United States, Iowa
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, United States, 52402
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's Hospital - South
Overland Park, Kansas, United States, 66213
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Mercy General Health Partners
Muskegon, Michigan, United States, 49444
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Heartland Hematology Oncology Associates, Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Parvin Radiation Oncology
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology, Incorporated
Saint Joseph, Missouri, United States, 64507
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
United States, Nebraska
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
Grand Island, Nebraska, United States, 68803
Callahan Cancer Center at Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69103
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States, 11042
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States, 28025
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States, 29615
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States, 29650
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Vermont
Mountainview Medical
Berlin Corners, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Clara Bloomfield, MD James Cancer Hospital and Solove Research Institute
More Information

Publications:
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.
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.
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.
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 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.
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.
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.
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.
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.
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00048958     History of Changes
Other Study ID Numbers: CALGB-8461
NCI-2009-00494 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
CDR0000256897 ( Registry Identifier: PDQ (Physician Data Query) )
3U24CA114725-09S1 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Multiple Myeloma
Syndrome
Leukemia
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Acute Disease
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Disease Attributes