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Cytogenetiske studier i akutt leukemi og multippelt myelom

16. august 2021 oppdatert av: Alliance for Clinical Trials in Oncology

Cytogenetiske studier i akutt leukemi og multippelt myelom: ledsager til CALGB-behandlingsstudier for tidligere ubehandlet akutt myeloid leukemi (AML), akutt lymfoblastisk leukemi (ALL), myelodysplastisk syndrom (MDS) eller multippelt myelom (MM) pasienter

Kromosomanalyse eller studiet av genetiske forskjeller hos pasienter som tidligere ikke er behandlet med AML, ALL, MDS eller MM kan være nyttig i diagnostisering og klassifisering av sykdom. Det kan også forbedre evnen til å forutsi sykdomsforløpet og valg av terapi. Institusjoner må enten ha en Alliance-godkjent cytogenetiker eller en avtale fra et Alliance-godkjent cytogenetisk laboratorium for hovedmedlem for å registrere en pasient på CALGB 8461. Listen over alliansens godkjente institusjonelle cytogenetikere er lagt ut på nettstedet til Alliance for Clinical Trials in Oncology.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Genetisk: cytogenetisk analyse

Studietype

Observasjonsmessig

Registrering (Forventet)

9000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pasientpopulasjon fra det kliniske onkologiske forskningsmiljøet inkludert akademiske institusjoner, sykehus og klinikker.

Beskrivelse

Pasienter fra hjelpemidler er kvalifisert hvis hovedmedlems cytogenetiklaboratoriet har samtykket i å behandle prøver fra det hjelpemidlet.
Innen én måned etter registrering på CALGB 8461, registrer deg på en CALGB-behandlingsstudie for tidligere ubehandlede AML-, ALL-, MDS- eller MM-pasienter.
Samtidig med registrering på CALGB 8461, registrer pasienter innenfor det kontinentale USA på CALGB 9665 (LTB).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort	Intervensjon / Behandling
Ingen behandling Prøver som definert i henhold til protokollen for tidligere ubehandlede pasienter med AML, ALL, MDS eller MM vil bli sendt inn for analyse og innen en måned må pasienter registrere seg på en CALGB-behandlingsstudie.	Genetisk: cytogenetisk analyse

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Bestem forekomsten av spesifikke mindre vanlige primære så vel som vanlige sekundære kromosomavvik i voksen AML, ALL, MDS og MM Tidsramme: Inntil 10 år	Inntil 10 år
Korreler spesifikke (normale eller forskjellige primære og sekundære kromosomavvik) med kliniske og laboratorieparametere Tidsramme: Inntil 10 år	Inntil 10 år
Korreler spesifikke karyotypegrupper med responsrater, responsvarighet, overlevelse og kur hos pasienter behandlet med ulike induksjons- og postinduksjonsregimer Tidsramme: Inntil 10 år	Inntil 10 år
Korreler spesifikke karyotypegrupper med utvalgte molekylære abnormiteter som studert i CALGB leukemiprotokoller Tidsramme: Inntil 10 år	Inntil 10 år
For å korrelere spesifikke karyotypegrupper med multimedikamentresistensdata Tidsramme: Inntil 10 år	Inntil 10 år
For å korrelere spesifikke karyotypegrupper med epidemiologiske data (toksisk eksponering og familiehistorie) Tidsramme: Inntil 10 år	Inntil 10 år
For å bestemme karyotypeendringer ved tilbakefall og påvirkningen av typen endring (eller ingen endring) i karyotype ved tilbakefall i påfølgende klinisk forløp Tidsramme: opptil 10 år	opptil 10 år
For å identifisere nye kromosomavvik som er viktige i leukemogenese Tidsramme: Inntil 10 år	Inntil 10 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

Studiestol: Clara Bloomfield, MD, James Cancer Hospital and Solove Research Institute

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Walker CJ, Kohlschmidt J, Eisfeld AK, Mrozek K, Liyanarachchi S, Song C, Nicolet D, Blachly JS, Bill M, Papaioannou D, Oakes CC, Giacopelli B, Genutis LK, Maharry SE, Orwick S, Archer KJ, Powell BL, Kolitz JE, Uy GL, Wang ES, Carroll AJ, Stone RM, Byrd JC, de la Chapelle A, Bloomfield CD. Genetic Characterization and Prognostic Relevance of Acquired Uniparental Disomies in Cytogenetically Normal Acute Myeloid Leukemia. Clin Cancer Res. 2019 Nov 1;25(21):6524-6531. doi: 10.1158/1078-0432.CCR-19-0725. Epub 2019 Aug 2.
Mims AS, Kohlschmidt J, Borate U, Blachly JS, Orwick S, Eisfeld AK, Papaioannou D, Nicolet D, Mromicronzek K, Stein E, Bhatnagar B, Stone RM, Kolitz JE, Wang ES, Powell BL, Burd A, Levine RL, Druker BJ, Bloomfield CD, Byrd JC. A precision medicine classification for treatment of acute myeloid leukemia in older patients. J Hematol Oncol. 2021 Jun 23;14(1):96. doi: 10.1186/s13045-021-01110-5.
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. doi: 10.1182/blood-2003-09-3118. Epub 2004 Feb 19.
Fobare S, Kohlschmidt J, Ozer HG, Mrozek K, Nicolet D, Mims AS, Garzon R, Blachly JS, Orwick S, Carroll AJ, Stone RM, Wang ES, Kolitz JE, Powell BL, Oakes CC, Eisfeld AK, Hertlein E, Byrd JC. Molecular, clinical, and prognostic implications of PTPN11 mutations in acute myeloid leukemia. Blood Adv. 2022 Mar 8;6(5):1371-1380. doi: 10.1182/bloodadvances.2021006242.
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. doi: 10.1200/JCO.2005.15.610.
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.
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. doi: 10.1182/blood-2003-02-0359. 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. doi: 10.1046/j.1365-2141.1996.d01-1687.x.
Cancer and Leukemia Group B 8461; 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 Jul 1;108(1):63-73. doi: 10.1182/blood-2005-11-4354. Epub 2006 Mar 7.
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. doi: 10.1200/JCO.2005.06.090. 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. doi: 10.1007/s00277-004-0850-2. 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. doi: 10.1002/cncr.20489.
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. doi: 10.1200/JCO.2004.07.012.
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, 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. doi: 10.1200/JCO.2004.03.023.
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; Cancer and Leukemia Group B (CALGB 8461). 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. doi: 10.1182/blood-2002-03-0772. Epub 2002 Aug 1.
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.
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. doi: 10.1200/JCO.1999.17.12.3767.
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. doi: 10.1038/sj.leu.2400933.
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. doi: 10.1046/j.1365-2141.1998.00714.x.
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. doi: 10.1200/JCO.1997.15.2.466.
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. doi: 10.1200/JCO.1996.14.9.2486.
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. doi: 10.1016/s0140-6736(96)90468-7.
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, Mrozek K, Mayer RJ, Davey FR, Tantravahi R, Pettenati MJ, Bigner S, Carroll AJ, Rao KW, Schiffer CA, Bloomfield CD. Secondary cytogenetic changes in acute promyelocytic leukemia--prognostic importance in patients treated with chemotherapy alone and association with the intron 3 breakpoint of the PML gene: a Cancer and Leukemia Group B study. J Clin Oncol. 1997 May;15(5):1786-95. doi: 10.1200/JCO.1997.15.5.1786.
Niederwieser C, Nicolet D, Carroll AJ, Kolitz JE, Powell BL, Kohlschmidt J, Stone RM, Byrd JC, Mrozek K, Bloomfield CD. Chromosome abnormalities at onset of complete remission are associated with worse outcome in patients with acute myeloid leukemia and an abnormal karyotype at diagnosis: CALGB 8461 (Alliance). Haematologica. 2016 Dec;101(12):1516-1523. doi: 10.3324/haematol.2016.149542. Epub 2016 Jul 28.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 1984

Primær fullføring (Forventet)

1. januar 2100

Datoer for studieregistrering

Først innsendt

12. november 2002

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

CALGB-8461
NCI-2009-00494 (Registeridentifikator: CTRP (Clinical Trials Reporting Program))
CDR0000256897 (Registeridentifikator: PDQ (Physician Data Query))
3U24CA114725-09S1 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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