<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03023384</url>
  </required_header>
  <id_info>
    <org_study_id>ICAML2015</org_study_id>
    <nct_id>NCT03023384</nct_id>
  </id_info>
  <brief_title>Feasibility Study of Intermediate Doses of ARA-C With Autologous SCT as Consolidation of Low/Intermediate-risk AML</brief_title>
  <acronym>ICAML2015</acronym>
  <official_title>Feasibility Study of the Use of Intermediate Doses of Cytarabine Associated With Autologous Hematopoietic Stem Cells as Consolidation Treatment of Young Adults With Low- or Intermediate-risk de Novo Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Consortium on Acute Leukemias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Consortium on Acute Leukemias</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Create a network of institutions in developing countries that will perform AML diagnosis,&#xD;
      risk classification, treatment, supportive care and follow-up evaluation according to a&#xD;
      common protocol and will register data using common clinical research forms (CRFs) in a&#xD;
      single database and available on the internet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Compare overall survival and disease-free survival of patients with acute myeloid&#xD;
           leukemia classified according the European LeukemiaNet treated in participating South&#xD;
           American hospitals with the results reported in developed countries.&#xD;
&#xD;
        2. Compare overall survival and disease-free survival of patients with AML low or&#xD;
           intermediate risk treated with two cycles of cytarabine in intermediate dose versus one&#xD;
           cytarabine cycle at the same dose followed by autologous SCT as consolidation. The risk&#xD;
           will be established according to the classification of the European LeukemiaNet.&#xD;
&#xD;
        3. Create a network of institutions in developing countries that will perform AML&#xD;
           diagnosis, risk classification, treatment, supportive care and follow-up evaluation&#xD;
           according to a common protocol and will register data using common clinical research&#xD;
           forms (CRFs) in a single database and available on the internet&#xD;
&#xD;
        4. Using National Reference Laboratories, provide cytogenetic and molecular methods for all&#xD;
           institutions participating in the network, thus allowing rapid diagnosis and risk&#xD;
           stratification of AML cases according to the European LeukemiaNet structure;&#xD;
&#xD;
        5. Develop a method of assessing minimal residual disease based on flow cytometry adapted&#xD;
           to local resources and capable of guiding therapeutic decisions;&#xD;
&#xD;
        6. Determine the time interval between: a) diagnosis and risk group determination; b) the&#xD;
           first cycle of consolidation chemotherapy and autologous hematopoietic stem cells&#xD;
           infusion;&#xD;
&#xD;
        7. Determine the frequency and etiologic agent of infections associated with treatment, the&#xD;
           number and average duration of hospitalization due to episodes of neutropenia;&#xD;
&#xD;
        8. Create a bank of samples of bone marrow from AML patients at different times of&#xD;
           treatment;&#xD;
&#xD;
        9. Determine the disease-free survival and the cumulative incidence rate of relapse and&#xD;
           non-relapse mortality and compare them between chemotherapy alone and chemotherapy plus&#xD;
           autologous SCT cohorts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from diagnosis until relapse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>Time from diagnosis until death from any cause</description>
  </secondary_outcome>
  <enrollment type="Anticipated">547</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood and Bone Marrow Aspirate&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with Acute Myeloid Leukemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute myeloid leukemia (AML) diagnosis according to WHO criteria;&#xD;
&#xD;
          2. AML not treated previously, including: de novo AML or secondary to myelodysplastic&#xD;
             syndromes;&#xD;
&#xD;
          3. Absence of t(15;17), or PML-RARA rearrangement and its variants (acute promyelocytic&#xD;
             leukemia diagnosis);&#xD;
&#xD;
          4. Age greater than or equal to 18 years old or lower than or equal to 65 years old;&#xD;
&#xD;
          5. Functional status ECOG from 0 to 2;&#xD;
&#xD;
          6. Signed informed consent;&#xD;
&#xD;
          7. Ability to follow the protocol procedures;&#xD;
&#xD;
          8. Willingness to use birth control methods during the treatment until its conclusion;&#xD;
&#xD;
          9. Adequate renal and liver function:&#xD;
&#xD;
               -  Bilirubin ≤ 1.5x the upper limit of normality;&#xD;
&#xD;
               -  AST and ALT ≤ 2.5x the upper limit of normality;&#xD;
&#xD;
               -  Creatinine ≤ 2.5 mg/dL.&#xD;
&#xD;
         10. Suitable cardiac function: left ventricular ejection fraction ≥ 50%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute promyelocytic leukemia (APL) diagnosis according to WHO criteria;&#xD;
&#xD;
          2. Diagnosis of acute leukemia of ambiguous lineage, biphenotypic acute leukemia or&#xD;
             undifferentiated acute leukemia, according to WHO criteria;&#xD;
&#xD;
          3. AML previously treated, except with hydroxyurea administration for cytoreduction;&#xD;
&#xD;
          4. Age greater than 65 years old or lower than 18 years old;&#xD;
&#xD;
          5. Functional status ECOG greater than 2;&#xD;
&#xD;
          6. Do not sign the informed consent;&#xD;
&#xD;
          7. Inability to follow the protocol procedures;&#xD;
&#xD;
          8. Be fertile female who are unwilling to take any birth control method during the&#xD;
             treatment;&#xD;
&#xD;
          9. Hypersensitivity to any drug of the treatment protocol;&#xD;
&#xD;
         10. Positive serology for HIV;&#xD;
&#xD;
         11. Altered liver and renal function not related to the primary disease (AML):&#xD;
&#xD;
               -  Bilirubin &gt; 1.5x the upper limit of normality&#xD;
&#xD;
               -  AST and ALT &gt; the 2.5x upper limit of normality&#xD;
&#xD;
               -  Creatinine &gt; 2.5 mg/dL&#xD;
&#xD;
        n) Altered cardiac function, with LVEF &lt;50%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo M Rego, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eduardo M Rego, MD</last_name>
    <phone>+55-16-2101-9361</phone>
    <email>emrego@hcrp.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michelle Lara</last_name>
    <phone>(202) 776-0544</phone>
    <phone_ext>4901</phone_ext>
    <email>mlara@hematology.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital das Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosane I Bittencourt, MD</last_name>
      <email>rbittencourt@hcpa.edu.br</email>
    </contact>
    <investigator>
      <last_name>Rosane I Bittencourt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Unicamp</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katia BB Pagnano, MD</last_name>
      <email>kborgia@unicamp.br</email>
    </contact>
    <investigator>
      <last_name>Katia BB Pagnano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas de Ribeirão Preto</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luisa CA Koury, MD</last_name>
      <phone>+55-16-98106-9709</phone>
      <email>luisa.koury.lk@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Luisa CA Koury, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Mario Covas</name>
      <address>
        <city>Santo Andre</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronald S Pallotta, MD</last_name>
      <email>rp.cohs@yahoo.com.br</email>
    </contact>
    <investigator>
      <last_name>Ronald S Pallotta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de São José do Rio Preto</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcos RP Oltramari, MD</last_name>
      <email>marcos.oltramari@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Marcos RP Oltramari, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thiago R Noronha, MD</last_name>
      <email>thinoronha@yahoo.com.br</email>
    </contact>
    <investigator>
      <last_name>Thiago R Noronha, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Burnett A, Wetzler M, Lowenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011 Feb 10;29(5):487-94. doi: 10.1200/JCO.2010.30.1820. Epub 2011 Jan 10. Erratum In: J Clin Oncol. 2011 Jun 1;29(16):2293.</citation>
    <PMID>21220605</PMID>
  </reference>
  <reference>
    <citation>Lowenberg B, Downing JR, Burnett A. Acute myeloid leukemia. N Engl J Med. 1999 Sep 30;341(14):1051-62. doi: 10.1056/NEJM199909303411407. No abstract available. Erratum In: N Engl J Med 1999 Nov 4;341(19):1484.</citation>
    <PMID>10502596</PMID>
  </reference>
  <reference>
    <citation>Lowenberg B. Sense and nonsense of high-dose cytarabine for acute myeloid leukemia. Blood. 2013 Jan 3;121(1):26-8. doi: 10.1182/blood-2012-07-444851.</citation>
    <PMID>23287624</PMID>
  </reference>
  <reference>
    <citation>Lowenberg B, Pabst T, Vellenga E, van Putten W, Schouten HC, Graux C, Ferrant A, Sonneveld P, Biemond BJ, Gratwohl A, de Greef GE, Verdonck LF, Schaafsma MR, Gregor M, Theobald M, Schanz U, Maertens J, Ossenkoppele GJ; Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) Collaborative Group. Cytarabine dose for acute myeloid leukemia. N Engl J Med. 2011 Mar 17;364(11):1027-36. doi: 10.1056/NEJMoa1010222.</citation>
    <PMID>21410371</PMID>
  </reference>
  <reference>
    <citation>Mrozek K, Marcucci G, Nicolet D, Maharry KS, Becker H, Whitman SP, Metzeler KH, Schwind S, Wu YZ, Kohlschmidt J, Pettenati MJ, Heerema NA, Block AW, Patil SR, Baer MR, Kolitz JE, Moore JO, Carroll AJ, Stone RM, Larson RA, Bloomfield CD. Prognostic significance of the European LeukemiaNet standardized system for reporting cytogenetic and molecular alterations in adults with acute myeloid leukemia. J Clin Oncol. 2012 Dec 20;30(36):4515-23. doi: 10.1200/JCO.2012.43.4738. Epub 2012 Sep 17.</citation>
    <PMID>22987078</PMID>
  </reference>
  <reference>
    <citation>Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.</citation>
    <PMID>22965967</PMID>
  </reference>
  <reference>
    <citation>Pfirrmann M, Ehninger G, Thiede C, Bornhauser M, Kramer M, Rollig C, Hasford J, Schaich M; Study Alliance Leukaemia (SAL). Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial. Lancet Oncol. 2012 Feb;13(2):207-14. doi: 10.1016/S1470-2045(11)70326-6. Epub 2011 Dec 22.</citation>
    <PMID>22197676</PMID>
  </reference>
  <reference>
    <citation>Grimwade D. The changing paradigm of prognostic factors in acute myeloid leukaemia. Best Pract Res Clin Haematol. 2012 Dec;25(4):419-25. doi: 10.1016/j.beha.2012.10.004. Epub 2012 Nov 4.</citation>
    <PMID>23200538</PMID>
  </reference>
  <reference>
    <citation>Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Lowenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. doi: 10.1182/blood-2009-07-235358. Epub 2009 Oct 30.</citation>
    <PMID>19880497</PMID>
  </reference>
  <reference>
    <citation>Rollig C, Bornhauser M, Thiede C, Taube F, Kramer M, Mohr B, Aulitzky W, Bodenstein H, Tischler HJ, Stuhlmann R, Schuler U, Stolzel F, von Bonin M, Wandt H, Schafer-Eckart K, Schaich M, Ehninger G. Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system. J Clin Oncol. 2011 Jul 10;29(20):2758-65. doi: 10.1200/JCO.2010.32.8500. Epub 2011 May 31.</citation>
    <PMID>21632498</PMID>
  </reference>
  <reference>
    <citation>Burnett AK, Wheatley K, Goldstone AH, Stevens RF, Hann IM, Rees JH, Harrison G; Medical Research Council Adult and Paediatric Working Parties. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol. 2002 Aug;118(2):385-400. doi: 10.1046/j.1365-2141.2002.03724.x.</citation>
    <PMID>12139722</PMID>
  </reference>
  <reference>
    <citation>Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ, Wadleigh M, DeAngelo DJ, Stone RM, Sakamaki H, Appelbaum FR, Dohner H, Antin JH, Soiffer RJ, Cutler C. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA. 2009 Jun 10;301(22):2349-61. doi: 10.1001/jama.2009.813.</citation>
    <PMID>19509382</PMID>
  </reference>
  <reference>
    <citation>Majhail NS, Bajorunaite R, Lazarus HM, Wang Z, Klein JP, Zhang MJ, Rizzo JD. High probability of long-term survival in 2-year survivors of autologous hematopoietic cell transplantation for AML in first or second CR. Bone Marrow Transplant. 2011 Mar;46(3):385-92. doi: 10.1038/bmt.2010.115. Epub 2010 May 17.</citation>
    <PMID>20479710</PMID>
  </reference>
  <reference>
    <citation>Nakasone H, Izutsu K, Wakita S, Yamaguchi H, Muramatsu-Kida M, Usuki K. Autologous stem cell transplantation with PCR-negative graft would be associated with a favorable outcome in core-binding factor acute myeloid leukemia. Biol Blood Marrow Transplant. 2008 Nov;14(11):1262-9. doi: 10.1016/j.bbmt.2008.08.012.</citation>
    <PMID>18940681</PMID>
  </reference>
  <reference>
    <citation>Breems DA, Boogaerts MA, Dekker AW, Van Putten WL, Sonneveld P, Huijgens PC, Van der Lelie J, Vellenga E, Gratwohl A, Verhoef GE, Verdonck LF, Lowenberg B. Autologous bone marrow transplantation as consolidation therapy in the treatment of adult patients under 60 years with acute myeloid leukaemia in first complete remission: a prospective randomized Dutch-Belgian Haemato-Oncology Co-operative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) trial. Br J Haematol. 2005 Jan;128(1):59-65. doi: 10.1111/j.1365-2141.2004.05282.x.</citation>
    <PMID>15606550</PMID>
  </reference>
  <reference>
    <citation>Wang J, Ouyang J, Zhou R, Chen B, Yang Y. Autologous hematopoietic stem cell transplantation for acute myeloid leukemia in first complete remission: a meta-analysis of randomized trials. Acta Haematol. 2010;124(2):61-71. doi: 10.1159/000314273. Epub 2010 Jul 10.</citation>
    <PMID>20616541</PMID>
  </reference>
  <reference>
    <citation>Nucci M, Garnica M, Gloria AB, Lehugeur DS, Dias VC, Palma LC, Cappellano P, Fertrin KY, Carlesse F, Simoes B, Bergamasco MD, Cunha CA, Seber A, Ribeiro MP, Queiroz-Telles F, Lee ML, Chauffaille ML, Silla L, de Souza CA, Colombo AL. Invasive fungal diseases in haematopoietic cell transplant recipients and in patients with acute myeloid leukaemia or myelodysplasia in Brazil. Clin Microbiol Infect. 2013 Aug;19(8):745-51. doi: 10.1111/1469-0691.12002. Epub 2012 Sep 25.</citation>
    <PMID>23009319</PMID>
  </reference>
  <reference>
    <citation>Levi I, Grotto I, Yerushalmi R, Ben-Bassat I, Shpilberg O. Meta-analysis of autologous bone marrow transplantation versus chemotherapy in adult patients with acute myeloid leukemia in first remission. Leuk Res. 2004 Jun;28(6):605-12. doi: 10.1016/j.leukres.2003.10.029.</citation>
    <PMID>15120937</PMID>
  </reference>
  <reference>
    <citation>Zittoun RA, Mandelli F, Willemze R, de Witte T, Labar B, Resegotti L, Leoni F, Damasio E, Visani G, Papa G, et al. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups. N Engl J Med. 1995 Jan 26;332(4):217-23. doi: 10.1056/NEJM199501263320403.</citation>
    <PMID>7808487</PMID>
  </reference>
  <reference>
    <citation>Keating A, DaSilva G, Perez WS, Gupta V, Cutler CS, Ballen KK, Cairo MS, Camitta BM, Champlin RE, Gajewski JL, Lazarus HM, Lill M, Marks DI, Nabhan C, Schiller GJ, Socie G, Szer J, Tallman MS, Weisdorf DJ. Autologous blood cell transplantation versus HLA-identical sibling transplantation for acute myeloid leukemia in first complete remission: a registry study from the Center for International Blood and Marrow Transplantation Research. Haematologica. 2013 Feb;98(2):185-92. doi: 10.3324/haematol.2012.062059. Epub 2012 Sep 14.</citation>
    <PMID>22983587</PMID>
  </reference>
  <reference>
    <citation>Capra M, Vilella L, Pereira WV, Coser VM, Fernandes MS, Schilling MA, Almeida D, Gross M, Leite M, Hellwig T, Natchigal G, Zelmanowicz A, Paskulin G, Neumann J, Silla L. Estimated number of cases, regional distribution and survival of patients diagnosed with acute myeloid leukemia between 1996 and 2000 in Rio Grande do Sul, Brazil. Leuk Lymphoma. 2007 Dec;48(12):2381-6. doi: 10.1080/10428190701713622.</citation>
    <PMID>18067014</PMID>
  </reference>
  <reference>
    <citation>Chan LL, Abdel-Latif ME, Ariffin WA, Ariffin H, Lin HP. Treating childhood acute myeloid leukaemia with the AML-BFM-83 protocol: experience in a developing country. Br J Haematol. 2004 Sep;126(6):799-805. doi: 10.1111/j.1365-2141.2004.05129.x.</citation>
    <PMID>15352983</PMID>
  </reference>
  <reference>
    <citation>Eid KA, Miranda EC, Vigorito AC, Aranha FJ, Oliveira GB, De Souza CA. The availability of full match sibling donors and feasibility of allogeneic bone marrow transplantation in Brazil. Braz J Med Biol Res. 2003 Mar;36(3):315-21. doi: 10.1590/s0100-879x2003000300005. Epub 2003 Mar 7.</citation>
    <PMID>12640495</PMID>
  </reference>
  <reference>
    <citation>Giebel S, Labopin M, Ehninger G, Beelen D, Blaise D, Ganser A, Bacigalupo A, Czerw T, Holowiecki J, Fagundes EM, Nowara E, Frassoni F, Rocha V; Acute Leukemia Working Party of the European Group for Blood and Marrow Transplantation. Association of Human Development Index with rates and outcomes of hematopoietic stem cell transplantation for patients with acute leukemia. Blood. 2010 Jul 8;116(1):122-8. doi: 10.1182/blood-2010-01-266478. Epub 2010 Apr 15.</citation>
    <PMID>20395416</PMID>
  </reference>
  <reference>
    <citation>Howard SC, Ortiz R, Baez LF, Cabanas R, Barrantes J, Fu L, Pena A, Samudio A, Vizcaino M, Rodriguez-Galindo C, Barr RD, Conter V, Biondi A, Masera G; MISPHO Consortium Writing Committee. Protocol-based treatment for children with cancer in low income countries in Latin America: a report on the recent meetings of the Monza International School of Pediatric Hematology/Oncology (MISPHO)--part II. Pediatr Blood Cancer. 2007 Apr;48(4):486-90. doi: 10.1002/pbc.20989.</citation>
    <PMID>16883600</PMID>
  </reference>
  <reference>
    <citation>Sandes AF, Ribeiro JC, Barroso RS, Silva MR, Chauffaille ML. Improving the outcomes of elderly patients with acute myeloid leukemia in a Brazilian University Hospital. Clinics (Sao Paulo). 2011;66(8):1335-40. doi: 10.1590/s1807-59322011000800005.</citation>
    <PMID>21915480</PMID>
  </reference>
  <reference>
    <citation>Xu XJ, Tang YM, Song H, Yang SL, Shi SW, Wei J. Long-term outcome of childhood acute myeloid leukemia in a developing country: experience from a children's hospital in China. Leuk Lymphoma. 2010 Dec;51(12):2262-9. doi: 10.3109/10428194.2010.518653. Epub 2010 Oct 7. Erratum In: Leuk Lymphoma. 2011 Mar;52(3):544.</citation>
    <PMID>20929322</PMID>
  </reference>
  <reference>
    <citation>Rowe JM. Optimal induction and post-remission therapy for AML in first remission. Hematology Am Soc Hematol Educ Program. 2009:396-405. doi: 10.1182/asheducation-2009.1.396.</citation>
    <PMID>20008225</PMID>
  </reference>
  <reference>
    <citation>Fagundes EM, Rocha V, Gloria AB, Clementino NC, Quintao JS, Guimaraes JP, Pedroso ER, Viana MB. De novo acute myeloid leukemia in adults younger than 60 years of age: socioeconomic aspects and treatment results in a Brazilian university center. Leuk Lymphoma. 2006 Aug;47(8):1557-64. doi: 10.1080/10428190600627055.</citation>
    <PMID>16966267</PMID>
  </reference>
  <reference>
    <citation>Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, Harris NL, Le Beau MM, Hellstrom-Lindberg E, Tefferi A, Bloomfield CD. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009 Jul 30;114(5):937-51. doi: 10.1182/blood-2009-03-209262. Epub 2009 Apr 8.</citation>
    <PMID>19357394</PMID>
  </reference>
  <reference>
    <citation>Scholl C, Gilliland DG, Frohling S. Deregulation of signaling pathways in acute myeloid leukemia. Semin Oncol. 2008 Aug;35(4):336-45. doi: 10.1053/j.seminoncol.2008.04.004.</citation>
    <PMID>18692684</PMID>
  </reference>
  <reference>
    <citation>Sternberg DW, Gilliland DG. The role of signal transducer and activator of transcription factors in leukemogenesis. J Clin Oncol. 2004 Jan 15;22(2):361-71. doi: 10.1200/JCO.2004.10.124.</citation>
    <PMID>14722044</PMID>
  </reference>
  <reference>
    <citation>Lin HK, Bergmann S, Pandolfi PP. Deregulated TGF-beta signaling in leukemogenesis. Oncogene. 2005 Aug 29;24(37):5693-700. doi: 10.1038/sj.onc.1208923.</citation>
    <PMID>16123802</PMID>
  </reference>
  <reference>
    <citation>Moe-Behrens GH, Pandolfi PP. Targeting aberrant transcriptional repression in acute myeloid leukemia. Rev Clin Exp Hematol. 2003 Jun;7(2):139-59.</citation>
    <PMID>14763160</PMID>
  </reference>
  <reference>
    <citation>Kosmider O, Moreau-Gachelin F. From mice to human: the &quot;two-hit model&quot; of leukemogenesis. Cell Cycle. 2006 Mar;5(6):569-70. doi: 10.4161/cc.5.6.2577. Epub 2006 Mar 15. No abstract available.</citation>
    <PMID>16582609</PMID>
  </reference>
  <reference>
    <citation>Grimwade D, Mrozek K. Diagnostic and prognostic value of cytogenetics in acute myeloid leukemia. Hematol Oncol Clin North Am. 2011 Dec;25(6):1135-61, vii. doi: 10.1016/j.hoc.2011.09.018.</citation>
    <PMID>22093581</PMID>
  </reference>
  <reference>
    <citation>Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.</citation>
    <PMID>23335087</PMID>
  </reference>
  <reference>
    <citation>Ohtake S, Miyawaki S, Fujita H, Kiyoi H, Shinagawa K, Usui N, Okumura H, Miyamura K, Nakaseko C, Miyazaki Y, Fujieda A, Nagai T, Yamane T, Taniwaki M, Takahashi M, Yagasaki F, Kimura Y, Asou N, Sakamaki H, Handa H, Honda S, Ohnishi K, Naoe T, Ohno R. Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSG AML201 Study. Blood. 2011 Feb 24;117(8):2358-65. doi: 10.1182/blood-2010-03-273243. Epub 2010 Aug 6.</citation>
    <PMID>20693429</PMID>
  </reference>
  <reference>
    <citation>Teuffel O, Leibundgut K, Lehrnbecher T, Alonzo TA, Beyene J, Sung L. Anthracyclines during induction therapy in acute myeloid leukaemia: a systematic review and meta-analysis. Br J Haematol. 2013 Apr;161(2):192-203. doi: 10.1111/bjh.12233. Epub 2013 Feb 8.</citation>
    <PMID>23398482</PMID>
  </reference>
  <reference>
    <citation>Burnett AK. New induction and postinduction strategies in acute myeloid leukemia. Curr Opin Hematol. 2012 Mar;19(2):76-81. doi: 10.1097/MOH.0b013e3283500a92.</citation>
    <PMID>22248879</PMID>
  </reference>
  <reference>
    <citation>Rego EM, Jacomo RH. Epidemiology and treatment of acute promyelocytic leukemia in latin america. Mediterr J Hematol Infect Dis. 2011;3(1):e2011049. doi: 10.4084/MJHID.2011.049. Epub 2011 Oct 24.</citation>
    <PMID>22110899</PMID>
  </reference>
  <reference>
    <citation>Rego EM, Kim HT, Ruiz-Arguelles GJ, Undurraga MS, Uriarte Mdel R, Jacomo RH, Gutierrez-Aguirre H, Melo RA, Bittencourt R, Pasquini R, Pagnano K, Fagundes EM, Chauffaille Mde L, Chiattone CS, Martinez L, Meillon LA, Gomez-Almaguer D, Kwaan HC, Garces-Eisele J, Gallagher R, Niemeyer CM, Schrier SL, Tallman M, Grimwade D, Ganser A, Berliner N, Ribeiro RC, Lo-Coco F, Lowenberg B, Sanz MA. Improving acute promyelocytic leukemia (APL) outcome in developing countries through networking, results of the International Consortium on APL. Blood. 2013 Mar 14;121(11):1935-43. doi: 10.1182/blood-2012-08-449918. Epub 2013 Jan 14.</citation>
    <PMID>23319575</PMID>
  </reference>
  <reference>
    <citation>Bucaneve G, Micozzi A, Menichetti F, Martino P, Dionisi MS, Martinelli G, Allione B, D'Antonio D, Buelli M, Nosari AM, Cilloni D, Zuffa E, Cantaffa R, Specchia G, Amadori S, Fabbiano F, Deliliers GL, Lauria F, Foa R, Del Favero A; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Infection Program. Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. N Engl J Med. 2005 Sep 8;353(10):977-87. doi: 10.1056/NEJMoa044097.</citation>
    <PMID>16148283</PMID>
  </reference>
  <reference>
    <citation>Gafter-Gvili A, Fraser A, Paul M, Vidal L, Lawrie TA, van de Wetering MD, Kremer LC, Leibovici L. Antibiotic prophylaxis for bacterial infections in afebrile neutropenic patients following chemotherapy. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD004386. doi: 10.1002/14651858.CD004386.pub3.</citation>
    <PMID>22258955</PMID>
  </reference>
  <reference>
    <citation>Robenshtok E, Gafter-Gvili A, Goldberg E, Weinberger M, Yeshurun M, Leibovici L, Paul M. Antifungal prophylaxis in cancer patients after chemotherapy or hematopoietic stem-cell transplantation: systematic review and meta-analysis. J Clin Oncol. 2007 Dec 1;25(34):5471-89. doi: 10.1200/JCO.2007.12.3851. Epub 2007 Oct 1.</citation>
    <PMID>17909198</PMID>
  </reference>
  <reference>
    <citation>Gafter-Gvili A, Fraser A, Paul M, Leibovici L. Meta-analysis: antibiotic prophylaxis reduces mortality in neutropenic patients. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):979-95. doi: 10.7326/0003-4819-142-12_part_1-200506210-00008. Erratum In: Ann Intern Med. 2006 May 2;144(9):704.</citation>
    <PMID>15968013</PMID>
  </reference>
  <reference>
    <citation>Garnica M, Nouer SA, Pellegrino FL, Moreira BM, Maiolino A, Nucci M. Ciprofloxacin prophylaxis in high risk neutropenic patients: effects on outcomes, antimicrobial therapy and resistance. BMC Infect Dis. 2013 Jul 31;13:356. doi: 10.1186/1471-2334-13-356.</citation>
    <PMID>23899356</PMID>
  </reference>
  <reference>
    <citation>Vellenga E, van Putten W, Ossenkoppele GJ, Verdonck LF, Theobald M, Cornelissen JJ, Huijgens PC, Maertens J, Gratwohl A, Schaafsma R, Schanz U, Graux C, Schouten HC, Ferrant A, Bargetzi M, Fey MF, Lowenberg B; Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON); Swiss Group for Clinical Cancer Research Collaborative Group (SAKK). Autologous peripheral blood stem cell transplantation for acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6037-42. doi: 10.1182/blood-2011-07-370247. Epub 2011 Sep 27.</citation>
    <PMID>21951683</PMID>
  </reference>
  <reference>
    <citation>Klein JP, Andersen PK. Regression modeling of competing risks data based on pseudovalues of the cumulative incidence function. Biometrics. 2005 Mar;61(1):223-9. doi: 10.1111/j.0006-341X.2005.031209.x.</citation>
    <PMID>15737097</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Myeloid Leukemia</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Autologous Stem Cell Transplantation</keyword>
  <keyword>Developing country</keyword>
  <keyword>Clinical network</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03023384
org study id: ICAML2015
nct id: NCT03023384
lead sponsor: 
has dmc: Yes
Create a network of institutions in developing countries that will perform AML diagnosis,
      risk classification, treatment, supportive care and follow-up evaluation according to a
      common protocol and will register data using common clinical research forms (CRFs) in a
      single database and available on the internet.
1. Compare overall survival and disease-free survival of patients with acute myeloid
           leukemia classified according the European LeukemiaNet treated in participating South
           American hospitals with the results reported in developed countries.

        2. Compare overall survival and disease-free survival of patients with AML low or
           intermediate risk treated with two cycles of cytarabine in intermediate dose versus one
           cytarabine cycle at the same dose followed by autologous SCT as consolidation. The risk
           will be established according to the classification of the European LeukemiaNet.

        3. Create a network of institutions in developing countries that will perform AML
           diagnosis, risk classification, treatment, supportive care and follow-up evaluation
           according to a common protocol and will register data using common clinical research
           forms (CRFs) in a single database and available on the internet

        4. Using National Reference Laboratories, provide cytogenetic and molecular methods for all
           institutions participating in the network, thus allowing rapid diagnosis and risk
           stratification of AML cases according to the European LeukemiaNet structure;

        5. Develop a method of assessing minimal residual disease based on flow cytometry adapted
           to local resources and capable of guiding therapeutic decisions;

        6. Determine the time interval between: a) diagnosis and risk group determination; b) the
           first cycle of consolidation chemotherapy and autologous hematopoietic stem cells
           infusion;

        7. Determine the frequency and etiologic agent of infections associated with treatment, the
           number and average duration of hospitalization due to episodes of neutropenia;

        8. Create a bank of samples of bone marrow from AML patients at different times of
           treatment;

        9. Determine the disease-free survival and the cumulative incidence rate of relapse and
           non-relapse mortality and compare them between chemotherapy alone and chemotherapy plus
           autologous SCT cohorts.
observational model: Other
time perspective: Prospective
measure: Disease free survival
time frame: 2 years
description: Time from diagnosis until relapse
measure: Overall survival
time frame: 2 years
description: Time from diagnosis until death from any cause
Whole blood and Bone Marrow Aspirate
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Eduardo M Rego, MD
role: Principal Investigator
affiliation: University of São Paulo
last name: Eduardo M Rego, MD
phone: +55-16-2101-9361
email: emrego@hcrp.usp.br
last name: Michelle Lara
phone: (202) 776-0544
phone ext: 4901
email: mlara@hematology.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
citation: Burnett A, Wetzler M, Lowenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011 Feb 10;29(5):487-94. doi: 10.1200/JCO.2010.30.1820. Epub 2011 Jan 10. Erratum In: J Clin Oncol. 2011 Jun 1;29(16):2293.
PMID: 21220605
citation: Lowenberg B, Downing JR, Burnett A. Acute myeloid leukemia. N Engl J Med. 1999 Sep 30;341(14):1051-62. doi: 10.1056/NEJM199909303411407. No abstract available. Erratum In: N Engl J Med 1999 Nov 4;341(19):1484.
PMID: 10502596
citation: Lowenberg B. Sense and nonsense of high-dose cytarabine for acute myeloid leukemia. Blood. 2013 Jan 3;121(1):26-8. doi: 10.1182/blood-2012-07-444851.
PMID: 23287624
citation: Lowenberg B, Pabst T, Vellenga E, van Putten W, Schouten HC, Graux C, Ferrant A, Sonneveld P, Biemond BJ, Gratwohl A, de Greef GE, Verdonck LF, Schaafsma MR, Gregor M, Theobald M, Schanz U, Maertens J, Ossenkoppele GJ; Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) Collaborative Group. Cytarabine dose for acute myeloid leukemia. N Engl J Med. 2011 Mar 17;364(11):1027-36. doi: 10.1056/NEJMoa1010222.
PMID: 21410371
citation: Mrozek K, Marcucci G, Nicolet D, Maharry KS, Becker H, Whitman SP, Metzeler KH, Schwind S, Wu YZ, Kohlschmidt J, Pettenati MJ, Heerema NA, Block AW, Patil SR, Baer MR, Kolitz JE, Moore JO, Carroll AJ, Stone RM, Larson RA, Bloomfield CD. Prognostic significance of the European LeukemiaNet standardized system for reporting cytogenetic and molecular alterations in adults with acute myeloid leukemia. J Clin Oncol. 2012 Dec 20;30(36):4515-23. doi: 10.1200/JCO.2012.43.4738. Epub 2012 Sep 17.
PMID: 22987078
citation: Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.
PMID: 22965967
citation: Pfirrmann M, Ehninger G, Thiede C, Bornhauser M, Kramer M, Rollig C, Hasford J, Schaich M; Study Alliance Leukaemia (SAL). Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial. Lancet Oncol. 2012 Feb;13(2):207-14. doi: 10.1016/S1470-2045(11)70326-6. Epub 2011 Dec 22.
PMID: 22197676
citation: Grimwade D. The changing paradigm of prognostic factors in acute myeloid leukaemia. Best Pract Res Clin Haematol. 2012 Dec;25(4):419-25. doi: 10.1016/j.beha.2012.10.004. Epub 2012 Nov 4.
PMID: 23200538
citation: Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Lowenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. doi: 10.1182/blood-2009-07-235358. Epub 2009 Oct 30.
PMID: 19880497
citation: Rollig C, Bornhauser M, Thiede C, Taube F, Kramer M, Mohr B, Aulitzky W, Bodenstein H, Tischler HJ, Stuhlmann R, Schuler U, Stolzel F, von Bonin M, Wandt H, Schafer-Eckart K, Schaich M, Ehninger G. Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system. J Clin Oncol. 2011 Jul 10;29(20):2758-65. doi: 10.1200/JCO.2010.32.8500. Epub 2011 May 31.
PMID: 21632498
citation: Burnett AK, Wheatley K, Goldstone AH, Stevens RF, Hann IM, Rees JH, Harrison G; Medical Research Council Adult and Paediatric Working Parties. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol. 2002 Aug;118(2):385-400. doi: 10.1046/j.1365-2141.2002.03724.x.
PMID: 12139722
citation: Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ, Wadleigh M, DeAngelo DJ, Stone RM, Sakamaki H, Appelbaum FR, Dohner H, Antin JH, Soiffer RJ, Cutler C. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA. 2009 Jun 10;301(22):2349-61. doi: 10.1001/jama.2009.813.
PMID: 19509382
citation: Majhail NS, Bajorunaite R, Lazarus HM, Wang Z, Klein JP, Zhang MJ, Rizzo JD. High probability of long-term survival in 2-year survivors of autologous hematopoietic cell transplantation for AML in first or second CR. Bone Marrow Transplant. 2011 Mar;46(3):385-92. doi: 10.1038/bmt.2010.115. Epub 2010 May 17.
PMID: 20479710
citation: Nakasone H, Izutsu K, Wakita S, Yamaguchi H, Muramatsu-Kida M, Usuki K. Autologous stem cell transplantation with PCR-negative graft would be associated with a favorable outcome in core-binding factor acute myeloid leukemia. Biol Blood Marrow Transplant. 2008 Nov;14(11):1262-9. doi: 10.1016/j.bbmt.2008.08.012.
PMID: 18940681
citation: Breems DA, Boogaerts MA, Dekker AW, Van Putten WL, Sonneveld P, Huijgens PC, Van der Lelie J, Vellenga E, Gratwohl A, Verhoef GE, Verdonck LF, Lowenberg B. Autologous bone marrow transplantation as consolidation therapy in the treatment of adult patients under 60 years with acute myeloid leukaemia in first complete remission: a prospective randomized Dutch-Belgian Haemato-Oncology Co-operative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) trial. Br J Haematol. 2005 Jan;128(1):59-65. doi: 10.1111/j.1365-2141.2004.05282.x.
PMID: 15606550
citation: Wang J, Ouyang J, Zhou R, Chen B, Yang Y. Autologous hematopoietic stem cell transplantation for acute myeloid leukemia in first complete remission: a meta-analysis of randomized trials. Acta Haematol. 2010;124(2):61-71. doi: 10.1159/000314273. Epub 2010 Jul 10.
PMID: 20616541
citation: Nucci M, Garnica M, Gloria AB, Lehugeur DS, Dias VC, Palma LC, Cappellano P, Fertrin KY, Carlesse F, Simoes B, Bergamasco MD, Cunha CA, Seber A, Ribeiro MP, Queiroz-Telles F, Lee ML, Chauffaille ML, Silla L, de Souza CA, Colombo AL. Invasive fungal diseases in haematopoietic cell transplant recipients and in patients with acute myeloid leukaemia or myelodysplasia in Brazil. Clin Microbiol Infect. 2013 Aug;19(8):745-51. doi: 10.1111/1469-0691.12002. Epub 2012 Sep 25.
PMID: 23009319
citation: Levi I, Grotto I, Yerushalmi R, Ben-Bassat I, Shpilberg O. Meta-analysis of autologous bone marrow transplantation versus chemotherapy in adult patients with acute myeloid leukemia in first remission. Leuk Res. 2004 Jun;28(6):605-12. doi: 10.1016/j.leukres.2003.10.029.
PMID: 15120937
citation: Zittoun RA, Mandelli F, Willemze R, de Witte T, Labar B, Resegotti L, Leoni F, Damasio E, Visani G, Papa G, et al. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia. European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups. N Engl J Med. 1995 Jan 26;332(4):217-23. doi: 10.1056/NEJM199501263320403.
PMID: 7808487
citation: Keating A, DaSilva G, Perez WS, Gupta V, Cutler CS, Ballen KK, Cairo MS, Camitta BM, Champlin RE, Gajewski JL, Lazarus HM, Lill M, Marks DI, Nabhan C, Schiller GJ, Socie G, Szer J, Tallman MS, Weisdorf DJ. Autologous blood cell transplantation versus HLA-identical sibling transplantation for acute myeloid leukemia in first complete remission: a registry study from the Center for International Blood and Marrow Transplantation Research. Haematologica. 2013 Feb;98(2):185-92. doi: 10.3324/haematol.2012.062059. Epub 2012 Sep 14.
PMID: 22983587
citation: Capra M, Vilella L, Pereira WV, Coser VM, Fernandes MS, Schilling MA, Almeida D, Gross M, Leite M, Hellwig T, Natchigal G, Zelmanowicz A, Paskulin G, Neumann J, Silla L. Estimated number of cases, regional distribution and survival of patients diagnosed with acute myeloid leukemia between 1996 and 2000 in Rio Grande do Sul, Brazil. Leuk Lymphoma. 2007 Dec;48(12):2381-6. doi: 10.1080/10428190701713622.
PMID: 18067014
citation: Chan LL, Abdel-Latif ME, Ariffin WA, Ariffin H, Lin HP. Treating childhood acute myeloid leukaemia with the AML-BFM-83 protocol: experience in a developing country. Br J Haematol. 2004 Sep;126(6):799-805. doi: 10.1111/j.1365-2141.2004.05129.x.
PMID: 15352983
citation: Eid KA, Miranda EC, Vigorito AC, Aranha FJ, Oliveira GB, De Souza CA. The availability of full match sibling donors and feasibility of allogeneic bone marrow transplantation in Brazil. Braz J Med Biol Res. 2003 Mar;36(3):315-21. doi: 10.1590/s0100-879x2003000300005. Epub 2003 Mar 7.
PMID: 12640495
citation: Giebel S, Labopin M, Ehninger G, Beelen D, Blaise D, Ganser A, Bacigalupo A, Czerw T, Holowiecki J, Fagundes EM, Nowara E, Frassoni F, Rocha V; Acute Leukemia Working Party of the European Group for Blood and Marrow Transplantation. Association of Human Development Index with rates and outcomes of hematopoietic stem cell transplantation for patients with acute leukemia. Blood. 2010 Jul 8;116(1):122-8. doi: 10.1182/blood-2010-01-266478. Epub 2010 Apr 15.
PMID: 20395416
citation: Howard SC, Ortiz R, Baez LF, Cabanas R, Barrantes J, Fu L, Pena A, Samudio A, Vizcaino M, Rodriguez-Galindo C, Barr RD, Conter V, Biondi A, Masera G; MISPHO Consortium Writing Committee. Protocol-based treatment for children with cancer in low income countries in Latin America: a report on the recent meetings of the Monza International School of Pediatric Hematology/Oncology (MISPHO)--part II. Pediatr Blood Cancer. 2007 Apr;48(4):486-90. doi: 10.1002/pbc.20989.
PMID: 16883600
citation: Sandes AF, Ribeiro JC, Barroso RS, Silva MR, Chauffaille ML. Improving the outcomes of elderly patients with acute myeloid leukemia in a Brazilian University Hospital. Clinics (Sao Paulo). 2011;66(8):1335-40. doi: 10.1590/s1807-59322011000800005.
PMID: 21915480
citation: Xu XJ, Tang YM, Song H, Yang SL, Shi SW, Wei J. Long-term outcome of childhood acute myeloid leukemia in a developing country: experience from a children's hospital in China. Leuk Lymphoma. 2010 Dec;51(12):2262-9. doi: 10.3109/10428194.2010.518653. Epub 2010 Oct 7. Erratum In: Leuk Lymphoma. 2011 Mar;52(3):544.
PMID: 20929322
citation: Rowe JM. Optimal induction and post-remission therapy for AML in first remission. Hematology Am Soc Hematol Educ Program. 2009:396-405. doi: 10.1182/asheducation-2009.1.396.
PMID: 20008225
citation: Fagundes EM, Rocha V, Gloria AB, Clementino NC, Quintao JS, Guimaraes JP, Pedroso ER, Viana MB. De novo acute myeloid leukemia in adults younger than 60 years of age: socioeconomic aspects and treatment results in a Brazilian university center. Leuk Lymphoma. 2006 Aug;47(8):1557-64. doi: 10.1080/10428190600627055.
PMID: 16966267
citation: Vardiman JW, Thiele J, Arber DA, Brunning RD, Borowitz MJ, Porwit A, Harris NL, Le Beau MM, Hellstrom-Lindberg E, Tefferi A, Bloomfield CD. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood. 2009 Jul 30;114(5):937-51. doi: 10.1182/blood-2009-03-209262. Epub 2009 Apr 8.
PMID: 19357394
citation: Scholl C, Gilliland DG, Frohling S. Deregulation of signaling pathways in acute myeloid leukemia. Semin Oncol. 2008 Aug;35(4):336-45. doi: 10.1053/j.seminoncol.2008.04.004.
PMID: 18692684
citation: Sternberg DW, Gilliland DG. The role of signal transducer and activator of transcription factors in leukemogenesis. J Clin Oncol. 2004 Jan 15;22(2):361-71. doi: 10.1200/JCO.2004.10.124.
PMID: 14722044
citation: Lin HK, Bergmann S, Pandolfi PP. Deregulated TGF-beta signaling in leukemogenesis. Oncogene. 2005 Aug 29;24(37):5693-700. doi: 10.1038/sj.onc.1208923.
PMID: 16123802
citation: Moe-Behrens GH, Pandolfi PP. Targeting aberrant transcriptional repression in acute myeloid leukemia. Rev Clin Exp Hematol. 2003 Jun;7(2):139-59.
PMID: 14763160
citation: Kosmider O, Moreau-Gachelin F. From mice to human: the "two-hit model" of leukemogenesis. Cell Cycle. 2006 Mar;5(6):569-70. doi: 10.4161/cc.5.6.2577. Epub 2006 Mar 15. No abstract available.
PMID: 16582609
citation: Grimwade D, Mrozek K. Diagnostic and prognostic value of cytogenetics in acute myeloid leukemia. Hematol Oncol Clin North Am. 2011 Dec;25(6):1135-61, vii. doi: 10.1016/j.hoc.2011.09.018.
PMID: 22093581
citation: Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PMID: 23335087
citation: Ohtake S, Miyawaki S, Fujita H, Kiyoi H, Shinagawa K, Usui N, Okumura H, Miyamura K, Nakaseko C, Miyazaki Y, Fujieda A, Nagai T, Yamane T, Taniwaki M, Takahashi M, Yagasaki F, Kimura Y, Asou N, Sakamaki H, Handa H, Honda S, Ohnishi K, Naoe T, Ohno R. Randomized study of induction therapy comparing standard-dose idarubicin with high-dose daunorubicin in adult patients with previously untreated acute myeloid leukemia: the JALSG AML201 Study. Blood. 2011 Feb 24;117(8):2358-65. doi: 10.1182/blood-2010-03-273243. Epub 2010 Aug 6.
PMID: 20693429
citation: Teuffel O, Leibundgut K, Lehrnbecher T, Alonzo TA, Beyene J, Sung L. Anthracyclines during induction therapy in acute myeloid leukaemia: a systematic review and meta-analysis. Br J Haematol. 2013 Apr;161(2):192-203. doi: 10.1111/bjh.12233. Epub 2013 Feb 8.
PMID: 23398482
citation: Burnett AK. New induction and postinduction strategies in acute myeloid leukemia. Curr Opin Hematol. 2012 Mar;19(2):76-81. doi: 10.1097/MOH.0b013e3283500a92.
PMID: 22248879
citation: Rego EM, Jacomo RH. Epidemiology and treatment of acute promyelocytic leukemia in latin america. Mediterr J Hematol Infect Dis. 2011;3(1):e2011049. doi: 10.4084/MJHID.2011.049. Epub 2011 Oct 24.
PMID: 22110899
citation: Rego EM, Kim HT, Ruiz-Arguelles GJ, Undurraga MS, Uriarte Mdel R, Jacomo RH, Gutierrez-Aguirre H, Melo RA, Bittencourt R, Pasquini R, Pagnano K, Fagundes EM, Chauffaille Mde L, Chiattone CS, Martinez L, Meillon LA, Gomez-Almaguer D, Kwaan HC, Garces-Eisele J, Gallagher R, Niemeyer CM, Schrier SL, Tallman M, Grimwade D, Ganser A, Berliner N, Ribeiro RC, Lo-Coco F, Lowenberg B, Sanz MA. Improving acute promyelocytic leukemia (APL) outcome in developing countries through networking, results of the International Consortium on APL. Blood. 2013 Mar 14;121(11):1935-43. doi: 10.1182/blood-2012-08-449918. Epub 2013 Jan 14.
PMID: 23319575
citation: Bucaneve G, Micozzi A, Menichetti F, Martino P, Dionisi MS, Martinelli G, Allione B, D'Antonio D, Buelli M, Nosari AM, Cilloni D, Zuffa E, Cantaffa R, Specchia G, Amadori S, Fabbiano F, Deliliers GL, Lauria F, Foa R, Del Favero A; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Infection Program. Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. N Engl J Med. 2005 Sep 8;353(10):977-87. doi: 10.1056/NEJMoa044097.
PMID: 16148283
citation: Gafter-Gvili A, Fraser A, Paul M, Vidal L, Lawrie TA, van de Wetering MD, Kremer LC, Leibovici L. Antibiotic prophylaxis for bacterial infections in afebrile neutropenic patients following chemotherapy. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD004386. doi: 10.1002/14651858.CD004386.pub3.
PMID: 22258955
citation: Robenshtok E, Gafter-Gvili A, Goldberg E, Weinberger M, Yeshurun M, Leibovici L, Paul M. Antifungal prophylaxis in cancer patients after chemotherapy or hematopoietic stem-cell transplantation: systematic review and meta-analysis. J Clin Oncol. 2007 Dec 1;25(34):5471-89. doi: 10.1200/JCO.2007.12.3851. Epub 2007 Oct 1.
PMID: 17909198
citation: Gafter-Gvili A, Fraser A, Paul M, Leibovici L. Meta-analysis: antibiotic prophylaxis reduces mortality in neutropenic patients. Ann Intern Med. 2005 Jun 21;142(12 Pt 1):979-95. doi: 10.7326/0003-4819-142-12_part_1-200506210-00008. Erratum In: Ann Intern Med. 2006 May 2;144(9):704.
PMID: 15968013
citation: Garnica M, Nouer SA, Pellegrino FL, Moreira BM, Maiolino A, Nucci M. Ciprofloxacin prophylaxis in high risk neutropenic patients: effects on outcomes, antimicrobial therapy and resistance. BMC Infect Dis. 2013 Jul 31;13:356. doi: 10.1186/1471-2334-13-356.
PMID: 23899356
citation: Vellenga E, van Putten W, Ossenkoppele GJ, Verdonck LF, Theobald M, Cornelissen JJ, Huijgens PC, Maertens J, Gratwohl A, Schaafsma R, Schanz U, Graux C, Schouten HC, Ferrant A, Bargetzi M, Fey MF, Lowenberg B; Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON); Swiss Group for Clinical Cancer Research Collaborative Group (SAKK). Autologous peripheral blood stem cell transplantation for acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6037-42. doi: 10.1182/blood-2011-07-370247. Epub 2011 Sep 27.
PMID: 21951683
citation: Klein JP, Andersen PK. Regression modeling of competing risks data based on pseudovalues of the cumulative incidence function. Biometrics. 2005 Mar;61(1):223-9. doi: 10.1111/j.0006-341X.2005.031209.x.
PMID: 15737097
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: No