<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/NCT03751410</url>
  </required_header>
  <id_info>
    <org_study_id>UHS-2</org_study_id>
    <secondary_id>U1111-1221-9732</secondary_id>
    <nct_id>NCT03751410</nct_id>
  </id_info>
  <brief_title>Chronic Ibrutinib Therapy Effect on Left Atrial Function</brief_title>
  <acronym>CITE-LA</acronym>
  <official_title>Long-term Effect of Chronic Ibrutinib Therapy on Left Atrial Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital &quot;Sestre Milosrdnice&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital &quot;Sestre Milosrdnice&quot;</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ibrutinib is an irreversible Bruton tyrosine-kinase inhibitor. In prospective studies, the&#xD;
      ibrutinib efficacy in the treatment of various B-cell malignancies was established. Different&#xD;
      ibrutinib side-effects have been found: diarrhea, arthralgia, infections, neutropenia,&#xD;
      hypertension and increased risk of bleeding. Most of the mentioned side-effects were &lt;3rd&#xD;
      degree of severity and mostly didn't require dose adjustment or therapy discontinuation.&#xD;
      Also, there was an increase in the incidence of atrial fibrillation (AFib) (6-16%). The AFib&#xD;
      pathogenesis in this patient population is not clarified, but there are indications that&#xD;
      ibrutinib inhibits phosphoinositide-3-kinase (PI3K)-Akt signal-pathway expressed in the&#xD;
      myocytes. Regardless of the molecular pathogenesis, the clinical effect of ibrutinib on the&#xD;
      myocardium, especially the left atrium, has not been studied. Hence, the aim of this study is&#xD;
      to determine the ibrutinib effect on echocardiographic parameters of left atrial function.&#xD;
&#xD;
      This study will be performed as a clinical, prospective, observational cohort study with a&#xD;
      structured follow-up period of 12 months. All consecutive patients with hemato-oncologic&#xD;
      diseases (including chronic lymphocytic leukemia, Mantle-cell lymphoma, Waldenstrom&#xD;
      macroglobulinemia, etc.) prescribed with chronic ibrutinib therapy, who are able to&#xD;
      understand and sign informed consent, will be enrolled. Primary objective is change of the&#xD;
      left atrial function measured by the decrease of the left atrial strain deformation &gt; 10%.&#xD;
&#xD;
      Recruiting should not exceed 12 months with the minimal follow-up period of 12 months (24&#xD;
      months in total). Standardized statistical methods and tests will be done using SPSS Version&#xD;
      22.0 or newer.&#xD;
&#xD;
      This unique study offers the possibility to show the long-term effect of chronic ibrutinib&#xD;
      therapy on left atrial function assessed by transthoracic echocardiography. This&#xD;
      observational data is needed to further refine the treatment of these patients and to prevent&#xD;
      possible side-effects of ibrutinib which could endanger this specific patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>left atrial function change</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>change of the left atrial function measured by the decrease of the left atrial strain deformation &gt; 10% assessed by transthoracic echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>left ventricular ejection fraction change</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>measurement of left ventricular systolic function change assessed by transthoracic echocardiography - method according to Simpson and Teicholz</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular diastolic function change</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>measurement of left ventricular diastolic function change assessed by transthoracic echocardiography (E/A and E/E')</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left atrial volume change</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>2D and 3D left atrial volume change assessed by transthoracic echocardiography + left atrial dimension in PLAX and 4 chamber projection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>P wave duration change</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>P wave duration and PQ interval duration change assessed in 12-lead electrocardiogram (in milliseconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left atrial pump function change</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>left atrial ejection fractionchange assessed by transthoracic echocardiography (doppler strain measurement method)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>atrial fibrillation incidence</measure>
    <time_frame>initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy</time_frame>
    <description>incidence of paroxysmal atrial fibrillation assessed by symptoms + ECG or 24-hours Holter-ECG</description>
  </secondary_outcome>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Atrium; Beat</condition>
  <condition>Echocardiography</condition>
  <condition>Physiology</condition>
  <condition>Therapy Adverse Effect</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients with haemato-oncologic diseases (including chronic lymphocytic&#xD;
        leukemia, Mantle-cell lymphoma, Waldenstrom macroglobulinaemia) prescribed with chronic&#xD;
        ibrutinib therapy, who are able to understand and sign informed consent, will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with haemato-oncologic diseases (including chronic lymphocytic leukemia,&#xD;
             Mantle-cell lymphoma, Waldenstrom macroglobulinaemia, etc.)&#xD;
&#xD;
          -  patients prescribed with chronic ibrutinib therapy&#xD;
&#xD;
          -  patients who are able to understand and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with haemato-oncologic diseases who were prescribed with concomitant&#xD;
             chemotherapy which can impact left atrial function&#xD;
&#xD;
          -  patients &lt; 18 years old&#xD;
&#xD;
          -  patients with known or at initial echocardiography established dilated cardiomyopathy&#xD;
             with left ventricular ejection fraction &lt; 35%&#xD;
&#xD;
          -  patients with permanent atrial fibrillation and dilated left atrium or dilated both&#xD;
             atriums&#xD;
&#xD;
          -  patients implanted with cardiac implantable electronic devices&#xD;
&#xD;
          -  patients who underwent cardiac surgery&#xD;
&#xD;
          -  patients with congenital heart diseases (surgically corrected or not)&#xD;
&#xD;
          -  patients with severe valvular pathology&#xD;
&#xD;
          -  patients with terminal renal disease&#xD;
&#xD;
          -  patients with chronic obstructive pulmonary disease - GOLD grade 4&#xD;
&#xD;
          -  patients with life expectancy &lt; 12 months&#xD;
&#xD;
          -  patients not willing to undergo clinical follow-up or sign informed consent&#xD;
&#xD;
          -  patients recruited in another clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matea Kolacevic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital &quot;Sestre Milosrdnice&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matea Kolacevic, MD</last_name>
    <phone>00385989166581</phone>
    <email>kolacevic.matea@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ivan Zeljkovic, MD</last_name>
    <phone>0038513787733</phone>
    <email>ivanzeljkov@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sestre milosrdnice University Hospital</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matea Kolacevic, M.D.</last_name>
      <phone>0038513787733</phone>
      <email>kolacevic.matea@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ivan Zeljkovic, MD., Ph.D.</last_name>
      <phone>00385917823289</phone>
      <email>ivanzeljkov@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <results_reference>
    <citation>Deeks ED. Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. Drugs. 2017 Feb;77(2):225-236. doi: 10.1007/s40265-017-0695-3.</citation>
    <PMID>28105602</PMID>
  </results_reference>
  <results_reference>
    <citation>Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.</citation>
    <PMID>24881631</PMID>
  </results_reference>
  <results_reference>
    <citation>Thompson PA, Burger JA. Bruton's tyrosine kinase inhibitors: first and second generation agents for patients with Chronic Lymphocytic Leukemia (CLL). Expert Opin Investig Drugs. 2018 Jan;27(1):31-42. doi: 10.1080/13543784.2018.1404027. Epub 2017 Nov 15.</citation>
    <PMID>29125406</PMID>
  </results_reference>
  <results_reference>
    <citation>Wierda WG, Zelenetz AD, Gordon LI, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Byrd JC, Caimi P, Fayad LE, Fisher RI, Glenn MJ, Habermann TM, Harris NL, Hernandez-Ilizaliturri F, Hoppe RT, Horwitz SM, Kaminski MS, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Martin MG, Nademanee A, Porcu P, Press O, Rabinovitch R, Reddy N, Reid E, Roberts K, Saad AA, Snyder ED, Sokol L, Swinnen LJ, Vose JM, Yahalom J, Dwyer MA, Sundar H. NCCN Guidelines Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 1.2017. J Natl Compr Canc Netw. 2017 Mar;15(3):293-311. doi: 10.6004/jnccn.2017.0030.</citation>
    <PMID>28275031</PMID>
  </results_reference>
  <results_reference>
    <citation>Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.</citation>
    <PMID>26639149</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaur V, Swami A. Ibrutinib in CLL: a focus on adverse events, resistance, and novel approaches beyond ibrutinib. Ann Hematol. 2017 Jul;96(7):1175-1184. doi: 10.1007/s00277-017-2973-2. Epub 2017 Mar 24.</citation>
    <PMID>28342031</PMID>
  </results_reference>
  <results_reference>
    <citation>O'Brien S, Hillmen P, Coutre S, Barr PM, Fraser G, Tedeschi A, Burger JA, Dilhuydy MS, Hess G, Moreno C, Cramer P, Liu E, Chang S, Vermeulen J, Styles L, Howes A, James DF, Patel K, Graef T, Valentino R. Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):648-657.e15. doi: 10.1016/j.clml.2018.06.016. Epub 2018 Jun 28.</citation>
    <PMID>30061088</PMID>
  </results_reference>
  <results_reference>
    <citation>Reda G, Fattizzo B, Cassin R, Mattiello V, Tonella T, Giannarelli D, Massari F, Cortelezzi A. Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study. J Hematol Oncol. 2018 Jun 11;11(1):79. doi: 10.1186/s13045-018-0626-0.</citation>
    <PMID>29891001</PMID>
  </results_reference>
  <results_reference>
    <citation>Boriani G, Corradini P, Cuneo A, Falanga A, Foa R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, Zinzani PL. Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding. Hematol Oncol. 2018 Oct;36(4):624-632. doi: 10.1002/hon.2503. Epub 2018 Mar 7.</citation>
    <PMID>29512173</PMID>
  </results_reference>
  <results_reference>
    <citation>Mato AR, Clasen S, Pickens P, Gashonia L, Rhodes J, Svoboda J, Hughes M, Nabhan C, Ali N, Schuster S, Carver J. Left atrial abnormality (LAA) as a predictor of ibrutinib-associated atrial fibrillation in patients with chronic lymphocytic leukemia. Cancer Biol Ther. 2018 Jan 2;19(1):1-2. doi: 10.1080/15384047.2017.1394554. Epub 2017 Dec 27.</citation>
    <PMID>29281559</PMID>
  </results_reference>
  <results_reference>
    <citation>Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. doi: 10.1182/blood-2016-05-712828. Epub 2016 May 31. No abstract available.</citation>
    <PMID>27247135</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital &quot;Sestre Milosrdnice&quot;</investigator_affiliation>
    <investigator_full_name>Ivan Zeljkovic</investigator_full_name>
    <investigator_title>Principal co-investigator</investigator_title>
  </responsible_party>
  <keyword>ibrutinib</keyword>
  <keyword>echocardiography</keyword>
  <keyword>left atrium</keyword>
  <keyword>function</keyword>
  <keyword>long-term</keyword>
  <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/NCT03751410
org study id: UHS-2
secondary id: U1111-1221-9732
nct id: NCT03751410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ibrutinib is an irreversible Bruton tyrosine-kinase inhibitor. In prospective studies, the
      ibrutinib efficacy in the treatment of various B-cell malignancies was established. Different
      ibrutinib side-effects have been found: diarrhea, arthralgia, infections, neutropenia,
      hypertension and increased risk of bleeding. Most of the mentioned side-effects were <3rd
      degree of severity and mostly didn't require dose adjustment or therapy discontinuation.
      Also, there was an increase in the incidence of atrial fibrillation (AFib) (6-16%). The AFib
      pathogenesis in this patient population is not clarified, but there are indications that
      ibrutinib inhibits phosphoinositide-3-kinase (PI3K)-Akt signal-pathway expressed in the
      myocytes. Regardless of the molecular pathogenesis, the clinical effect of ibrutinib on the
      myocardium, especially the left atrium, has not been studied. Hence, the aim of this study is
      to determine the ibrutinib effect on echocardiographic parameters of left atrial function.

      This study will be performed as a clinical, prospective, observational cohort study with a
      structured follow-up period of 12 months. All consecutive patients with hemato-oncologic
      diseases (including chronic lymphocytic leukemia, Mantle-cell lymphoma, Waldenstrom
      macroglobulinemia, etc.) prescribed with chronic ibrutinib therapy, who are able to
      understand and sign informed consent, will be enrolled. Primary objective is change of the
      left atrial function measured by the decrease of the left atrial strain deformation > 10%.

      Recruiting should not exceed 12 months with the minimal follow-up period of 12 months (24
      months in total). Standardized statistical methods and tests will be done using SPSS Version
      22.0 or newer.

      This unique study offers the possibility to show the long-term effect of chronic ibrutinib
      therapy on left atrial function assessed by transthoracic echocardiography. This
      observational data is needed to further refine the treatment of these patients and to prevent
      possible side-effects of ibrutinib which could endanger this specific patient population.
observational model: Cohort
time perspective: Prospective
measure: left atrial function change
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: change of the left atrial function measured by the decrease of the left atrial strain deformation > 10% assessed by transthoracic echocardiography
measure: left ventricular ejection fraction change
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: measurement of left ventricular systolic function change assessed by transthoracic echocardiography - method according to Simpson and Teicholz
measure: left ventricular diastolic function change
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: measurement of left ventricular diastolic function change assessed by transthoracic echocardiography (E/A and E/E')
measure: left atrial volume change
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: 2D and 3D left atrial volume change assessed by transthoracic echocardiography + left atrial dimension in PLAX and 4 chamber projection
measure: P wave duration change
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: P wave duration and PQ interval duration change assessed in 12-lead electrocardiogram (in milliseconds)
measure: left atrial pump function change
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: left atrial ejection fractionchange assessed by transthoracic echocardiography (doppler strain measurement method)
measure: atrial fibrillation incidence
time frame: initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy
description: incidence of paroxysmal atrial fibrillation assessed by symptoms + ECG or 24-hours Holter-ECG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matea Kolacevic, MD
role: Principal Investigator
affiliation: University Hospital "Sestre Milosrdnice"
last name: Matea Kolacevic, MD
phone: 00385989166581
email: kolacevic.matea@gmail.com
last name: Ivan Zeljkovic, MD
phone: 0038513787733
email: ivanzeljkov@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Croatia
citation: Deeks ED. Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. Drugs. 2017 Feb;77(2):225-236. doi: 10.1007/s40265-017-0695-3.
PMID: 28105602
citation: Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
PMID: 24881631
citation: Thompson PA, Burger JA. Bruton's tyrosine kinase inhibitors: first and second generation agents for patients with Chronic Lymphocytic Leukemia (CLL). Expert Opin Investig Drugs. 2018 Jan;27(1):31-42. doi: 10.1080/13543784.2018.1404027. Epub 2017 Nov 15.
PMID: 29125406
citation: Wierda WG, Zelenetz AD, Gordon LI, Abramson JS, Advani RH, Andreadis CB, Bartlett N, Byrd JC, Caimi P, Fayad LE, Fisher RI, Glenn MJ, Habermann TM, Harris NL, Hernandez-Ilizaliturri F, Hoppe RT, Horwitz SM, Kaminski MS, Kelsey CR, Kim YH, Krivacic S, LaCasce AS, Martin MG, Nademanee A, Porcu P, Press O, Rabinovitch R, Reddy N, Reid E, Roberts K, Saad AA, Snyder ED, Sokol L, Swinnen LJ, Vose JM, Yahalom J, Dwyer MA, Sundar H. NCCN Guidelines Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 1.2017. J Natl Compr Canc Netw. 2017 Mar;15(3):293-311. doi: 10.6004/jnccn.2017.0030.
PMID: 28275031
citation: Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.
PMID: 26639149
citation: Kaur V, Swami A. Ibrutinib in CLL: a focus on adverse events, resistance, and novel approaches beyond ibrutinib. Ann Hematol. 2017 Jul;96(7):1175-1184. doi: 10.1007/s00277-017-2973-2. Epub 2017 Mar 24.
PMID: 28342031
citation: O'Brien S, Hillmen P, Coutre S, Barr PM, Fraser G, Tedeschi A, Burger JA, Dilhuydy MS, Hess G, Moreno C, Cramer P, Liu E, Chang S, Vermeulen J, Styles L, Howes A, James DF, Patel K, Graef T, Valentino R. Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2018 Oct;18(10):648-657.e15. doi: 10.1016/j.clml.2018.06.016. Epub 2018 Jun 28.
PMID: 30061088
citation: Reda G, Fattizzo B, Cassin R, Mattiello V, Tonella T, Giannarelli D, Massari F, Cortelezzi A. Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study. J Hematol Oncol. 2018 Jun 11;11(1):79. doi: 10.1186/s13045-018-0626-0.
PMID: 29891001
citation: Boriani G, Corradini P, Cuneo A, Falanga A, Foa R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, Zinzani PL. Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding. Hematol Oncol. 2018 Oct;36(4):624-632. doi: 10.1002/hon.2503. Epub 2018 Mar 7.
PMID: 29512173
citation: Mato AR, Clasen S, Pickens P, Gashonia L, Rhodes J, Svoboda J, Hughes M, Nabhan C, Ali N, Schuster S, Carver J. Left atrial abnormality (LAA) as a predictor of ibrutinib-associated atrial fibrillation in patients with chronic lymphocytic leukemia. Cancer Biol Ther. 2018 Jan 2;19(1):1-2. doi: 10.1080/15384047.2017.1394554. Epub 2017 Dec 27.
PMID: 29281559
citation: Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. doi: 10.1182/blood-2016-05-712828. Epub 2016 May 31. No abstract available.
PMID: 27247135
responsible party type: Principal Investigator
investigator affiliation: University Hospital "Sestre Milosrdnice"
investigator full name: Ivan Zeljkovic
investigator title: Principal co-investigator
sharing ipd: No