<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/NCT03042676</url>
  </required_header>
  <id_info>
    <org_study_id>271/2016/O/Oss</org_study_id>
    <nct_id>NCT03042676</nct_id>
  </id_info>
  <brief_title>Electronic Database for the Follow up of the ATG_FamilyStudy</brief_title>
  <acronym>AFF</acronym>
  <official_title>Observational, Electronic Database With a Prospective Phase and Retrospective Phase for the Follow up of the ATG_FamilyStudy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clínico Universitario de Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Chaim Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</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>
      Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of&#xD;
      acute leukemias. The most important post-transplant complication is graft vs host disease&#xD;
      (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin&#xD;
      (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any&#xD;
      increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number,&#xD;
      NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease&#xD;
      in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG&#xD;
      (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting&#xD;
      of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA&#xD;
      identical sibling donor after myeloablative preparative regimen. In particular, the GVHD&#xD;
      extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a&#xD;
      minimum follow up of 2 years from transplant. The investigators would like to evaluate the&#xD;
      longer term follow up of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the ATG_familystudy (prospective, randomised, multicenter study) a decrease in the&#xD;
      incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG (10&#xD;
      mg/kg for three days from day -3 to -1) to the standard GVHD prophylaxis in the setting of&#xD;
      acute leukemias in any remission, receiving peripheral blood stem cells from an HLA identical&#xD;
      sibling donor after myeloablative preparative regimen. In particular, the GVHD extensive form&#xD;
      was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a minimum follow up of&#xD;
      2 years from transplant.&#xD;
&#xD;
      The primary endpoint is the creation of a multicenter electronic database with data of the&#xD;
      patients previously enrolled in the ATG_family study, NCT00678275; the data collection will&#xD;
      last ten years. Schedule of the follow-up will have be until death and will be stopped any&#xD;
      time if patient will retire the consent.&#xD;
&#xD;
      The database will allow to evaluate:&#xD;
&#xD;
        -  Long term mortality of enrolled patients, with and without GVHD&#xD;
&#xD;
        -  Long term relapse after allogeneic HSCT in acute leukemia patients&#xD;
&#xD;
        -  Prognostic factors in the overall population and according to the randomization arm&#xD;
&#xD;
        -  Recovery of working activity&#xD;
&#xD;
      Study design&#xD;
&#xD;
      Multicenter, observational, prospective cohorting study (electronic database) with a&#xD;
      retrospective phase.&#xD;
&#xD;
      Prospective phase:&#xD;
&#xD;
      the electronic database will include patients enrolled in the ATG_familystudy and routinely&#xD;
      followed up at the Hematological Institutions participating to the study.&#xD;
&#xD;
      Retrospective phase:&#xD;
&#xD;
      data collection will review all patients enrolled in the ATG familystudy (medical chart&#xD;
      review) and already dead or lost at follow up after the end of the ATG_familystudy by medical&#xD;
      chart review (Feb 2014).&#xD;
&#xD;
      The electronic database will include all patients enrolled in the ATG_familystudy.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  patients included in the ATG_familystudy (NCT00678275)&#xD;
&#xD;
        -  informed consent given&#xD;
&#xD;
      Exclusion criteria: none&#xD;
&#xD;
      Treatment: no treatment is envisaged; patients are followed up according to standard clinical&#xD;
      practice and international guidelines.&#xD;
&#xD;
      Visit and evaluation&#xD;
&#xD;
      Prospective phase: patients will be followed with visits (mainly as outpatients), laboratory&#xD;
      and instrumental tests, phone contacts as provided for the clinic route.&#xD;
&#xD;
      Retrospective phase: medical chart review&#xD;
&#xD;
      Informed consent: patients will be asked to sign the written consent during a visit as an&#xD;
      outpatient or inpatient, if required.&#xD;
&#xD;
      Confidentiality of collected information:&#xD;
&#xD;
      the principal investigator is the responsible of data treatment. Collected data will be&#xD;
      analyzed by statistical methods in anonymous way in order to obtain the information&#xD;
      representing the aim of the study. The electronic database will be accessible only by&#xD;
      authorized persons. The principal investigator and the coworkers will have the access to&#xD;
      data: everyone will be obliged to data confidentiality.&#xD;
&#xD;
      Electronic database&#xD;
&#xD;
        -  The electronic database will include all patients enrolled in the ATG_familystudy. The&#xD;
           data collection about hospital admittance and medical evaluations performed as&#xD;
           outpatient will be done by medical records/charts analysis. In this way, biographical&#xD;
           data, anamnestic data and any information about signs and symptoms at the onset of&#xD;
           disease, diagnostic roadmap and treatment will be collected.&#xD;
&#xD;
        -  For patients unreachable by phone details given by the patients or for patients already&#xD;
           dead, data will be taken by the analysis of the medical charts or by the Office of vital&#xD;
           statistics, after EC approval. Patients lost at follow up are patients unreachable in&#xD;
           anyway by the details given by the patient him/herself.&#xD;
&#xD;
        -  In the electronic database data on patients enrolled in the ATGfamilystudy will be&#xD;
           included from the date of EC approval. For dead and lost at follow up patients data will&#xD;
           be recorded retrospectively.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      The investigators will use cumulative incidence analysis to assess chronic GVHD-free survival&#xD;
      and relapse-free survival and labeled death before the event of interest as a competing risk.&#xD;
      Death from relapse will be used as a competing risk for the cumulative incidence analysis of&#xD;
      death without relapse. Overall survival will be assessed with the use of Kaplan- Meier&#xD;
      analysis. Further treatment- group comparisons were performed with the use of chi-square&#xD;
      tests for nominal data, Mann-Whitney U-tests for ordinal data, and analyses of variance for&#xD;
      interval or ratio-scale data. Exploratory, post hoc, Cox multiple regression analysis was&#xD;
      used for subgroup analyses and for the purpose of determining the effect on the incidence of&#xD;
      chronic GVHD and on overall survival of recipient age, first versus second remission, acute&#xD;
      lymphoblastic versus acute myeloid leukemia, cytogenetic risk, risk of underlying disease,&#xD;
      difference between the sex of the donor and the sex of the recipient, cytomegalovirus&#xD;
      positivity in the recipient, type of conditioning, CD34+ cells transplanted, grade of acute&#xD;
      GVHD and chronic GVHD (time dependent [i.e., the corresponding event can occur at different&#xD;
      points in time after transplantation]) in addition to treatment assignment (ATG vs. non-ATG)&#xD;
      in the original ATG_familystudy. Confidence intervals for the differences in risk according&#xD;
      to treatment group will be determined with the use of Wilson's method. Cumulative incidence&#xD;
      analyses will be performed with the use of NCSS statistical software, version 9, and R&#xD;
      statistical software, version 2.10.1 (cmprsk package). IBM SPSS Statistics software, version&#xD;
      22.0, will be used for all other analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 8, 2018</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>10 Years</target_duration>
  <primary_outcome>
    <measure>cumulative incidence of cGVHD</measure>
    <time_frame>cumulative incidence of cGVHD through study competition, an average of 24 months</time_frame>
    <description>cumulative incidence according to Fine and Gray method, labeling death before the event of interest as a competing risk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival after allogeneic stem cell transplant</measure>
    <time_frame>overall survival through study competition, an average of 24 months</time_frame>
    <description>Kaplan-Meyer estimate of survival after transplant.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cumulative incidence of relapse after allogeneic stem cell transplant</measure>
    <time_frame>Relapse Incidence through study competition, an average of 24 months</time_frame>
    <description>cumulative incidence according to Fine and Gray method, labeling death before relapse as a competing risk.</description>
  </other_outcome>
  <other_outcome>
    <measure>Recovery of working activity</measure>
    <time_frame>Recovery of working activity after transplant anytime through study competition, an average of 24 months</time_frame>
    <description>descriptive measures (retired, came back to work, unemployed) during a standard follow up visit</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">104</enrollment>
  <condition>GVHD, Chronic</condition>
  <condition>Acute Leukemia</condition>
  <condition>Stem Cell Transplant Complications</condition>
  <arm_group>
    <arm_group_label>ATLG group</arm_group_label>
    <description>ATLG treatment for GVHD prophylaxis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no ATLG group</arm_group_label>
    <description>No ATLG treatment.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The electronic database will include all patients enrolled in the ATG_familystudy&#xD;
        (NCT00678275).&#xD;
&#xD;
        Multicenter, observational, prospective cohorting study (electronic database) with a&#xD;
        retrospective phase.&#xD;
&#xD;
        Prospective phase:&#xD;
&#xD;
        the electronic database will include patients enrolled in the ATG_familystudy and routinely&#xD;
        followed up at the Hematological Institutions participating to the study.&#xD;
&#xD;
        Retrospective phase:&#xD;
&#xD;
        data collection will review all patients enrolled in the ATG familystudy (medical chart&#xD;
        review) and already dead or lost at follow up after the end of the ATG_familystudy by&#xD;
        medical chart review (Feb 2014)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients already enrolled in the ATG_family_study (NCT00678275), and published by&#xD;
             Kroger N et al. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host&#xD;
             Disease. N Engl J Med 2016;374:43-53&#xD;
&#xD;
          -  informed consent given&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>Francesca Bonifazi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Orsola-Malpighi University Hospital Bologna, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hematology - Sant'Orsola-Malpighi Hospital</name>
      <address>
        <city>Bologna</city>
        <state>Bo</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Kroger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, Nagler A, Selleri C, Risitano A, Messina G, Bethge W, Perez de Oteiza J, Duarte R, Carella AM, Cimminiello M, Guidi S, Finke J, Mordini N, Ferra C, Sierra J, Russo D, Petrini M, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Bonifazi F. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N Engl J Med. 2016 Jan 7;374(1):43-53. doi: 10.1056/NEJMoa1506002.</citation>
    <PMID>26735993</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonifazi F, Solano C, Wolschke C, Sessa M, Patriarca F, Zallio F, Nagler A, Selleri C, Risitano AM, Messina G, Bethge W, Herrera P, Sureda A, Carella AM, Cimminiello M, Guidi S, Finke J, Sorasio R, Ferra C, Sierra J, Russo D, Benedetti E, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Kroger N. Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study. Lancet Haematol. 2019 Feb;6(2):e89-e99. doi: 10.1016/S2352-3026(18)30214-X. Erratum In: Lancet Haematol. 2019 Mar;6(3):e121.</citation>
    <PMID>30709437</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Francesca Bonifazi, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>anti-T lymphocytic globulin (ATG)</keyword>
  <keyword>allogeneic stem cell transplant</keyword>
  <keyword>prophylaxis of GVHD</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/NCT03042676
org study id: 271/2016/O/Oss
nct id: NCT03042676
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of
      acute leukemias. The most important post-transplant complication is graft vs host disease
      (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin
      (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any
      increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number,
      NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease
      in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG
      (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting
      of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA
      identical sibling donor after myeloablative preparative regimen. In particular, the GVHD
      extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a
      minimum follow up of 2 years from transplant. The investigators would like to evaluate the
      longer term follow up of this study.
In the ATG_familystudy (prospective, randomised, multicenter study) a decrease in the
      incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG (10
      mg/kg for three days from day -3 to -1) to the standard GVHD prophylaxis in the setting of
      acute leukemias in any remission, receiving peripheral blood stem cells from an HLA identical
      sibling donor after myeloablative preparative regimen. In particular, the GVHD extensive form
      was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a minimum follow up of
      2 years from transplant.

      The primary endpoint is the creation of a multicenter electronic database with data of the
      patients previously enrolled in the ATG_family study, NCT00678275; the data collection will
      last ten years. Schedule of the follow-up will have be until death and will be stopped any
      time if patient will retire the consent.

      The database will allow to evaluate:

        -  Long term mortality of enrolled patients, with and without GVHD

        -  Long term relapse after allogeneic HSCT in acute leukemia patients

        -  Prognostic factors in the overall population and according to the randomization arm

        -  Recovery of working activity

      Study design

      Multicenter, observational, prospective cohorting study (electronic database) with a
      retrospective phase.

      Prospective phase:

      the electronic database will include patients enrolled in the ATG_familystudy and routinely
      followed up at the Hematological Institutions participating to the study.

      Retrospective phase:

      data collection will review all patients enrolled in the ATG familystudy (medical chart
      review) and already dead or lost at follow up after the end of the ATG_familystudy by medical
      chart review (Feb 2014).

      The electronic database will include all patients enrolled in the ATG_familystudy.

      Inclusion criteria:

        -  patients included in the ATG_familystudy (NCT00678275)

        -  informed consent given

      Exclusion criteria: none

      Treatment: no treatment is envisaged; patients are followed up according to standard clinical
      practice and international guidelines.

      Visit and evaluation

      Prospective phase: patients will be followed with visits (mainly as outpatients), laboratory
      and instrumental tests, phone contacts as provided for the clinic route.

      Retrospective phase: medical chart review

      Informed consent: patients will be asked to sign the written consent during a visit as an
      outpatient or inpatient, if required.

      Confidentiality of collected information:

      the principal investigator is the responsible of data treatment. Collected data will be
      analyzed by statistical methods in anonymous way in order to obtain the information
      representing the aim of the study. The electronic database will be accessible only by
      authorized persons. The principal investigator and the coworkers will have the access to
      data: everyone will be obliged to data confidentiality.

      Electronic database

        -  The electronic database will include all patients enrolled in the ATG_familystudy. The
           data collection about hospital admittance and medical evaluations performed as
           outpatient will be done by medical records/charts analysis. In this way, biographical
           data, anamnestic data and any information about signs and symptoms at the onset of
           disease, diagnostic roadmap and treatment will be collected.

        -  For patients unreachable by phone details given by the patients or for patients already
           dead, data will be taken by the analysis of the medical charts or by the Office of vital
           statistics, after EC approval. Patients lost at follow up are patients unreachable in
           anyway by the details given by the patient him/herself.

        -  In the electronic database data on patients enrolled in the ATGfamilystudy will be
           included from the date of EC approval. For dead and lost at follow up patients data will
           be recorded retrospectively.

      Statistical analysis

      The investigators will use cumulative incidence analysis to assess chronic GVHD-free survival
      and relapse-free survival and labeled death before the event of interest as a competing risk.
      Death from relapse will be used as a competing risk for the cumulative incidence analysis of
      death without relapse. Overall survival will be assessed with the use of Kaplan- Meier
      analysis. Further treatment- group comparisons were performed with the use of chi-square
      tests for nominal data, Mann-Whitney U-tests for ordinal data, and analyses of variance for
      interval or ratio-scale data. Exploratory, post hoc, Cox multiple regression analysis was
      used for subgroup analyses and for the purpose of determining the effect on the incidence of
      chronic GVHD and on overall survival of recipient age, first versus second remission, acute
      lymphoblastic versus acute myeloid leukemia, cytogenetic risk, risk of underlying disease,
      difference between the sex of the donor and the sex of the recipient, cytomegalovirus
      positivity in the recipient, type of conditioning, CD34+ cells transplanted, grade of acute
      GVHD and chronic GVHD (time dependent [i.e., the corresponding event can occur at different
      points in time after transplantation]) in addition to treatment assignment (ATG vs. non-ATG)
      in the original ATG_familystudy. Confidence intervals for the differences in risk according
      to treatment group will be determined with the use of Wilson's method. Cumulative incidence
      analyses will be performed with the use of NCSS statistical software, version 9, and R
      statistical software, version 2.10.1 (cmprsk package). IBM SPSS Statistics software, version
      22.0, will be used for all other analysis.
observational model: Cohort
time perspective: Prospective
measure: cumulative incidence of cGVHD
time frame: cumulative incidence of cGVHD through study competition, an average of 24 months
description: cumulative incidence according to Fine and Gray method, labeling death before the event of interest as a competing risk.
measure: Overall survival after allogeneic stem cell transplant
time frame: overall survival through study competition, an average of 24 months
description: Kaplan-Meyer estimate of survival after transplant.
measure: Cumulative incidence of relapse after allogeneic stem cell transplant
time frame: Relapse Incidence through study competition, an average of 24 months
description: cumulative incidence according to Fine and Gray method, labeling death before relapse as a competing risk.
measure: Recovery of working activity
time frame: Recovery of working activity after transplant anytime through study competition, an average of 24 months
description: descriptive measures (retired, came back to work, unemployed) during a standard follow up visit
arm group label: ATLG group
description: ATLG treatment for GVHD prophylaxis.
arm group label: no ATLG group
description: No ATLG treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Francesca Bonifazi, MD
role: Principal Investigator
affiliation: St. Orsola-Malpighi University Hospital Bologna, Italy
facility: 
country: Italy
citation: Kroger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, Nagler A, Selleri C, Risitano A, Messina G, Bethge W, Perez de Oteiza J, Duarte R, Carella AM, Cimminiello M, Guidi S, Finke J, Mordini N, Ferra C, Sierra J, Russo D, Petrini M, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Bonifazi F. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N Engl J Med. 2016 Jan 7;374(1):43-53. doi: 10.1056/NEJMoa1506002.
PMID: 26735993
citation: Bonifazi F, Solano C, Wolschke C, Sessa M, Patriarca F, Zallio F, Nagler A, Selleri C, Risitano AM, Messina G, Bethge W, Herrera P, Sureda A, Carella AM, Cimminiello M, Guidi S, Finke J, Sorasio R, Ferra C, Sierra J, Russo D, Benedetti E, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Kroger N. Acute GVHD prophylaxis plus ATLG after myeloablative allogeneic haemopoietic peripheral blood stem-cell transplantation from HLA-identical siblings in patients with acute myeloid leukaemia in remission: final results of quality of life and long-term outcome analysis of a phase 3 randomised study. Lancet Haematol. 2019 Feb;6(2):e89-e99. doi: 10.1016/S2352-3026(18)30214-X. Erratum In: Lancet Haematol. 2019 Mar;6(3):e121.
PMID: 30709437
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Francesca Bonifazi, MD
investigator title: MD
sharing ipd: No