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急性白血病和多发性骨髓瘤的细胞遗传学研究

2021年8月16日更新者：Alliance for Clinical Trials in Oncology

急性白血病和多发性骨髓瘤的细胞遗传学研究：CALGB 治疗研究的伴侣，用于先前未治疗的急性髓性白血病 (AML)、急性淋巴细胞白血病 (ALL)、骨髓增生异常综合征 (MDS) 或多发性骨髓瘤 (MM) 患者

以前未接受过 AML、ALL、MDS 或 MM 治疗的患者的染色体分析或遗传差异研究可能有助于疾病的诊断和分类。它还可以提高预测疾病过程和治疗选择的能力。机构必须有联盟批准的细胞遗传学家或联盟批准的主要成员细胞遗传学实验室的协议，才能在 CALGB 8461 上招收患者。联盟批准的机构细胞遗传学家名单发布在肿瘤临床试验联盟网站上。

研究概览

地位

主动，不招人

条件

干预/治疗

遗传的：细胞遗传学分析

研究类型

观察性的

注册 (预期的)

9000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

来自临床肿瘤学研究社区的患者群体，包括学术机构、医院和诊所。

描述

如果主要成员细胞遗传学实验室同意处理来自该附属机构的样本，则来自附属机构的患者符合条件。
在 CALGB 8461 注册后的一个月内，为先前未治疗的 AML、ALL、MDS 或 MM 患者注册 CALGB 治疗研究。
在 CALGB 8461 上注册的同时，将美国大陆的患者注册到 CALGB 9665 (LTB) 上。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列	干预/治疗
没有治疗根据协议为先前未治疗的 AML、ALL、MDS 或 MM 患者定义的样本将被提交进行分析，并且患者需要在一个月内注册参加 CALGB 治疗研究。	遗传的：细胞遗传学分析

研究衡量的是什么？

主要结果指标

结果测量	大体时间
确定成人 AML、ALL、MDS 和 MM 中特定的不太常见的原发性和常见的继发性染色体异常的发生率大体时间：长达 10 年	长达 10 年
将特定（正常或各种原发性和继发性染色体异常）与临床和实验室参数相关联大体时间：长达 10 年	长达 10 年
将特定核型组与接受各种诱导和诱导后方案治疗的患者的反应率、反应持续时间、生存和治愈相关联大体时间：长达 10 年	长达 10 年
将特定核型组与 CALGB 白血病方案中研究的选定分子异常相关联大体时间：长达 10 年	长达 10 年
将特定核型组与多药耐药数据相关联大体时间：长达 10 年	长达 10 年
将特定核型组与流行病学数据（毒性暴露和家族史）相关联大体时间：长达 10 年	长达 10 年
确定复发时的核型变化以及复发时核型变化类型（或无变化）对后续临床过程的影响大体时间：长达 10 年	长达 10 年
鉴定在白血病发生中重要的新染色体异常大体时间：长达 10 年	长达 10 年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

调查人员

学习椅：Clara Bloomfield, MD、James Cancer Hospital and Solove Research Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

1984年6月1日

初级完成 (预期的)

2100年1月1日

研究注册日期

首次提交

2002年11月12日

首先提交符合 QC 标准的

2003年1月26日

首次发布 (估计)

2003年1月27日

研究记录更新

最后更新发布 (实际的)

2021年8月17日

上次提交的符合 QC 标准的更新

2021年8月16日

最后验证

2021年8月1日

细胞遗传学分析的临床试验

Hvidovre University Hospital
ElsassFonden

终止

Cadiotocography 结合 ST 分析与 Cardiotocography 结合头皮 pH 值

新生儿代谢性酸中毒

丹麦

急性白血病和多发性骨髓瘤的细胞遗传学研究