<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/NCT02222272</url>
  </required_header>
  <id_info>
    <org_study_id>EBMT-42201038</org_study_id>
    <nct_id>NCT02222272</nct_id>
  </id_info>
  <brief_title>Effect of 2nd Gen TKI in CML</brief_title>
  <official_title>Effect of Prior Therapy With Nilotinib or Dasatinib on the Outcome After Allogeneic Stem Cell Transplantation for Patients With Chronic Myeloid Leukaemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Society for Blood and Marrow Transplantation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>European Society for Blood and Marrow Transplantation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stem cell transplantation will continue to be a treatment option for patients with chronic&#xD;
      myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many&#xD;
      patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the&#xD;
      time of allogeneic stem cell transplantation.&#xD;
&#xD;
      While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact&#xD;
      on the outcome of allogeneic stem cell transplantation little is known on the impact of prior&#xD;
      use of second generation TK inhibitors.&#xD;
&#xD;
      Therefore this non interventional prospective study addresses this question and patients&#xD;
      undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will&#xD;
      be followed by the data office office on engraftment, treatment related mortality, relapse&#xD;
      rate and survival, prospectively. Details on TKI therapy will be collected by the&#xD;
      participating centers, retrospectively.&#xD;
&#xD;
      This is a non interventional prospective study. There is no upper limit to the number of&#xD;
      patients entered, but it is estimated that up to 450 patients will be included in 150 centres&#xD;
      for this non interventional prospective study. The registry will include patients for three&#xD;
      years plus one more year for follow up and data analysis which should then be followed-up&#xD;
      until the projected end of the non interventional prospective study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic myeloid leukemia (CML) is a clonal disorder characterized by the chromosomal&#xD;
      translocation t(9;22) which produces a fusion gene encoding the chimeric oncoprotein, BCR-&#xD;
      ABL. This protein harbors a deregulated constitutive activated tyrosine kinase (TK) leading&#xD;
      to leukemogenesis [1].&#xD;
&#xD;
      Imatinib mesylate, the first potent selective inhibitor of BCR-ABL TK [2] has become the&#xD;
      frontline therapy for newly diagnosed CML patients [3]. It can induce haematologic and&#xD;
      cytogenetic remission in all stages of CML, as well as in Ph positive acute lymphoblastic&#xD;
      leukaemia (Ph+ ALL) with minimal toxicity [4, 5]. However, resistance and relapse during&#xD;
      imatinib treatment are increasingly reported [6] and complete molecular remissions, as&#xD;
      measured by polymerase chain reaction (PCR) are rare [7-9]. Loss of response to imatinib is&#xD;
      frequently associated with mutations in the kinase domain of BCR-ABL which lead to impaired&#xD;
      imatinib binding [10-12].&#xD;
&#xD;
      Nilotinib and Dasatinib are orally available kinase inhibitors that can overcome resistance&#xD;
      to Imatinib [13 - 15]. Recent studies have demonstrated the efficacy and safety of both&#xD;
      Nilotinib and Dasatinib in all stages of imatinib resistant CML. However, the long-term&#xD;
      durability of these responses is uncertain yet, and substantial toxicity has been encountered&#xD;
      [16]. Major adverse events observed during Nilotinib therapy were cytopenias, bone marrow&#xD;
      suppression, gastrointestinal haemorrhage, diarrhea, cardiac dysfunction, liver toxicities&#xD;
      and dermatitis [17-19] and during Dasatinib therapy grade 3/4 thrombocytopenia and&#xD;
      neutropenia were reported in nearly half of the patients and non-hematologic toxicity&#xD;
      consisted primarily of diarrhea, headache, fatigue, dyspnea and pleural effusion [20, 21].&#xD;
&#xD;
      Allogeneic stem cell transplantation (SCT) is now used mainly as salvage or curative therapy&#xD;
      in patients with advanced CML who were previously treated with imatinib. While one study&#xD;
      showed higher incidence of graft versus host disease (GVHD), venoocclusive disease (VOD) and&#xD;
      transplant related mortality (TRM) [22], most studies have demonstrated that imatinib therapy&#xD;
      prior to allogeneic SCT doesn't adversely affect transplantation outcome [23,24] . By&#xD;
      contrast, previously used therapies for CML including busulfan and interferon alpha (if&#xD;
      administrated less than 3 months before allogeneic SCT) have been reported to increase&#xD;
      transplant related toxicities and mortality in CML patients undergoing allogeneic SCT [25,&#xD;
      26].&#xD;
&#xD;
      The impact of pre-transplant nilotinib or dasatinib therapy on transplant related&#xD;
      complications, morbidity and outcome is mostly unknown and only two small case series have as&#xD;
      yet been reported on this topic [27, 28]. However, allogeneic SCT will continue to be used as&#xD;
      a salvage or curative therapy for CML especially in cases with resistance to kinase&#xD;
      inhibitors or in patients at high risk of relapse, such as those in second chronic phase&#xD;
      after blast crisis [29]. In the future 2nd generation TKIs may replace at least in part&#xD;
      imatinib as frontline therapy for CML or will continue to be used in imatinib resistant&#xD;
      patients. Nevertheless, in high risk patients allogeneic transplantation appears to remain&#xD;
      the only curative treatment option.&#xD;
&#xD;
      For this reason, it is important to determine whether these novel treatments will not&#xD;
      compromise transplantation outcome and increase transplant related complications.&#xD;
&#xD;
      Research design:&#xD;
&#xD;
      This is a non interventional prospective study with regard to SCT and follow-up. Patients&#xD;
      agreeing to SCT will be identified from the EBMT database and from the transplant physicians.&#xD;
      Transplant centres for the non interventional prospective study will be chosen from the EBMT&#xD;
      centers that have transplanted patients with CML over the past 5 years. Transplant centers&#xD;
      willing to participate will be registered with the EBMT Leiden Office. A prospective registry&#xD;
      will keep record of all patients undergoing allogeneic SCT who had received prior treatment&#xD;
      with 2nd generation TKIs and a specific data collection form (MED-B / MED-C) will be sent to&#xD;
      the transplant centre to capture the relevant information at the appropriate intervals (day&#xD;
      +100; 1 year; 2 years). Data will be collected regarding the safety and feasibility of stem&#xD;
      cell transplant after Nilotinib or Dasatinib therapy (see endpoints).&#xD;
&#xD;
      The data on the treatment of patients with Nilotinib or Dasatinib before SCT will be&#xD;
      collected retrospectively as part of the medical history (retrospective data collection).&#xD;
      Participating centers planning an allogeneic SCT in a patient with CML previously treated&#xD;
      with Nilotinib or Dasatinib will register the patient with the EBMT Leiden Office prior to&#xD;
      transplant (day 0). A specific MED-C form will be sent to the centers immediately after&#xD;
      registration.&#xD;
&#xD;
      All patients transplanted in an EBMT centre give specific consent for the collection and&#xD;
      release of clinical data to the EBMT registry. Therefore, all patients registered in this non&#xD;
      interventional prospective study would have signed an informed consent to authorise the&#xD;
      release of medical information to the EBMT for the non interventional prospective study. Each&#xD;
      centre will use their own standard consent form and information sheet. No specific consent&#xD;
      form is envisaged for this non interventional prospective study.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      This is an observational non interventional prospective study using the existing framework of&#xD;
      the EBMT to identify and include patients. In 2006 560 patients with CML received an&#xD;
      allotransplant, coming down from 800 in 2003. The percentage of patients transplanted not in&#xD;
      first chronic phase is constantly increasing. Currently no data are available how many of&#xD;
      those had previously been treated with 2nd generation TKI: it is however assumed, that also&#xD;
      the number of patients transplanted after therapy with second generation TKI is increasing.&#xD;
&#xD;
      An estimate number is that for the next three years approximately 1500 allotransplants for&#xD;
      CML will be done. 60% of these pts (n=900) would have received 2nd generation TKI. Assuming&#xD;
      that at least 50% of them will be registered in the non interventional prospective study, it&#xD;
      is expected that up to 450 patients will be identified over the next three years.&#xD;
&#xD;
      Patients response status to treatment with second line TKI (e.g. in stable CCyR, MCyR, or&#xD;
      resistant to or progressing under 2nd line TKI) will be recorded to allow for identification&#xD;
      of subgroups.&#xD;
&#xD;
      Research variables:&#xD;
&#xD;
        -  Patients' features&#xD;
&#xD;
        -  Centres' features&#xD;
&#xD;
        -  Initial diagnosis&#xD;
&#xD;
        -  Subclassification and status of disease at start 2nd generation TKI&#xD;
&#xD;
        -  Response status to treatment with 2nd generation TKI prior to SCT&#xD;
&#xD;
        -  TKI treatment (dose; duration; response)&#xD;
&#xD;
        -  Subclassification and status of disease at HSCT&#xD;
&#xD;
        -  Complications&#xD;
&#xD;
        -  Additional therapies&#xD;
&#xD;
        -  Relapse or progression&#xD;
&#xD;
        -  Last disease and patient status&#xD;
&#xD;
        -  Donor&#xD;
&#xD;
        -  Transplantation&#xD;
&#xD;
        -  Graft manipulation&#xD;
&#xD;
        -  Engraftment&#xD;
&#xD;
        -  Comorbid conditions&#xD;
&#xD;
        -  Preparative treatment&#xD;
&#xD;
        -  Graft versus Host disease&#xD;
&#xD;
        -  Follow up&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      All correspondence will go through the data centre in Leiden. The data manager from the&#xD;
      selected centre will complete the study forms. The data manager from the selected centre,&#xD;
      national registry or the Paris office will collect the data forms and will enter the MED-B&#xD;
      specific items. The MED-C items will be collected and entered by the data centre in Leiden.&#xD;
      Data analysis will be done centrally at the CLWP office.&#xD;
&#xD;
      In case of inconsistencies a second check will be performed by a research assistant/data&#xD;
      manager of the CLWP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">September 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 19, 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>non-relapse mortality (NRM) (treatment related mortality)</measure>
    <time_frame>1 year after HSCT</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>treatment related toxic effects</measure>
    <time_frame>2 year after HSCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 years after HSCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival</measure>
    <time_frame>2 years after HSCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse Rate</measure>
    <time_frame>2 years after HSCT</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>outcome analyzed by response status to 2nd gen TKI prior to SCT</measure>
    <time_frame>2 year after HSCT</time_frame>
  </other_outcome>
  <enrollment type="Actual">432</enrollment>
  <condition>Myeloid Leukemia, Chronic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        eligible patients from EBMT centres&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients with chronic myeloid leukaemia in any phase (chronic, accelerated&#xD;
             or blastic) who undergo allogeneic stem cell transplantation between 01/01/2010 and&#xD;
             30/09/2013 and have been previously treated with Nilotinib or Dasatinib, regardless of&#xD;
             their response to these drugs.&#xD;
&#xD;
        Exclusion Criteria:&#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>Michael Schleuning, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zentrum für Knochenmark und Blutstammzelltransplantation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduardo Olavarria, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital de Navarra, Servicio de Hematologia, Pamplona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolaus kroeger, MD</last_name>
    <role>Study Chair</role>
    <affiliation>BMT Centre, University Hospital Eppendorf, Hamburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Freiburg</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Muenster</name>
      <address>
        <city>Muenster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Ivan &amp; St Laszlo Hospital</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Centre</name>
      <address>
        <city>Tel-Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Silesia</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Petersburg State Medical Pavlov University</name>
      <address>
        <city>St Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital &amp; Research Centre</name>
      <address>
        <city>Riyadh</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Saudi Arabia</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 14, 2019</last_update_submitted>
  <last_update_submitted_qc>August 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cml</keyword>
  <keyword>chronic myeloid leukemia</keyword>
  <keyword>dasatinib</keyword>
  <keyword>nilotinib</keyword>
  <keyword>tki</keyword>
  <keyword>second generation tki</keyword>
  <keyword>2nd generation tki</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, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02222272
org study id: EBMT-42201038
nct id: NCT02222272
lead sponsor: 
collaborator: 
has dmc: No
Stem cell transplantation will continue to be a treatment option for patients with chronic
      myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many
      patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the
      time of allogeneic stem cell transplantation.

      While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact
      on the outcome of allogeneic stem cell transplantation little is known on the impact of prior
      use of second generation TK inhibitors.

      Therefore this non interventional prospective study addresses this question and patients
      undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will
      be followed by the data office office on engraftment, treatment related mortality, relapse
      rate and survival, prospectively. Details on TKI therapy will be collected by the
      participating centers, retrospectively.

      This is a non interventional prospective study. There is no upper limit to the number of
      patients entered, but it is estimated that up to 450 patients will be included in 150 centres
      for this non interventional prospective study. The registry will include patients for three
      years plus one more year for follow up and data analysis which should then be followed-up
      until the projected end of the non interventional prospective study.
Chronic myeloid leukemia (CML) is a clonal disorder characterized by the chromosomal
      translocation t(9;22) which produces a fusion gene encoding the chimeric oncoprotein, BCR-
      ABL. This protein harbors a deregulated constitutive activated tyrosine kinase (TK) leading
      to leukemogenesis [1].

      Imatinib mesylate, the first potent selective inhibitor of BCR-ABL TK [2] has become the
      frontline therapy for newly diagnosed CML patients [3]. It can induce haematologic and
      cytogenetic remission in all stages of CML, as well as in Ph positive acute lymphoblastic
      leukaemia (Ph+ ALL) with minimal toxicity [4, 5]. However, resistance and relapse during
      imatinib treatment are increasingly reported [6] and complete molecular remissions, as
      measured by polymerase chain reaction (PCR) are rare [7-9]. Loss of response to imatinib is
      frequently associated with mutations in the kinase domain of BCR-ABL which lead to impaired
      imatinib binding [10-12].

      Nilotinib and Dasatinib are orally available kinase inhibitors that can overcome resistance
      to Imatinib [13 - 15]. Recent studies have demonstrated the efficacy and safety of both
      Nilotinib and Dasatinib in all stages of imatinib resistant CML. However, the long-term
      durability of these responses is uncertain yet, and substantial toxicity has been encountered
      [16]. Major adverse events observed during Nilotinib therapy were cytopenias, bone marrow
      suppression, gastrointestinal haemorrhage, diarrhea, cardiac dysfunction, liver toxicities
      and dermatitis [17-19] and during Dasatinib therapy grade 3/4 thrombocytopenia and
      neutropenia were reported in nearly half of the patients and non-hematologic toxicity
      consisted primarily of diarrhea, headache, fatigue, dyspnea and pleural effusion [20, 21].

      Allogeneic stem cell transplantation (SCT) is now used mainly as salvage or curative therapy
      in patients with advanced CML who were previously treated with imatinib. While one study
      showed higher incidence of graft versus host disease (GVHD), venoocclusive disease (VOD) and
      transplant related mortality (TRM) [22], most studies have demonstrated that imatinib therapy
      prior to allogeneic SCT doesn't adversely affect transplantation outcome [23,24] . By
      contrast, previously used therapies for CML including busulfan and interferon alpha (if
      administrated less than 3 months before allogeneic SCT) have been reported to increase
      transplant related toxicities and mortality in CML patients undergoing allogeneic SCT [25,
      26].

      The impact of pre-transplant nilotinib or dasatinib therapy on transplant related
      complications, morbidity and outcome is mostly unknown and only two small case series have as
      yet been reported on this topic [27, 28]. However, allogeneic SCT will continue to be used as
      a salvage or curative therapy for CML especially in cases with resistance to kinase
      inhibitors or in patients at high risk of relapse, such as those in second chronic phase
      after blast crisis [29]. In the future 2nd generation TKIs may replace at least in part
      imatinib as frontline therapy for CML or will continue to be used in imatinib resistant
      patients. Nevertheless, in high risk patients allogeneic transplantation appears to remain
      the only curative treatment option.

      For this reason, it is important to determine whether these novel treatments will not
      compromise transplantation outcome and increase transplant related complications.

      Research design:

      This is a non interventional prospective study with regard to SCT and follow-up. Patients
      agreeing to SCT will be identified from the EBMT database and from the transplant physicians.
      Transplant centres for the non interventional prospective study will be chosen from the EBMT
      centers that have transplanted patients with CML over the past 5 years. Transplant centers
      willing to participate will be registered with the EBMT Leiden Office. A prospective registry
      will keep record of all patients undergoing allogeneic SCT who had received prior treatment
      with 2nd generation TKIs and a specific data collection form (MED-B / MED-C) will be sent to
      the transplant centre to capture the relevant information at the appropriate intervals (day
      +100; 1 year; 2 years). Data will be collected regarding the safety and feasibility of stem
      cell transplant after Nilotinib or Dasatinib therapy (see endpoints).

      The data on the treatment of patients with Nilotinib or Dasatinib before SCT will be
      collected retrospectively as part of the medical history (retrospective data collection).
      Participating centers planning an allogeneic SCT in a patient with CML previously treated
      with Nilotinib or Dasatinib will register the patient with the EBMT Leiden Office prior to
      transplant (day 0). A specific MED-C form will be sent to the centers immediately after
      registration.

      All patients transplanted in an EBMT centre give specific consent for the collection and
      release of clinical data to the EBMT registry. Therefore, all patients registered in this non
      interventional prospective study would have signed an informed consent to authorise the
      release of medical information to the EBMT for the non interventional prospective study. Each
      centre will use their own standard consent form and information sheet. No specific consent
      form is envisaged for this non interventional prospective study.

      Study Population:

      This is an observational non interventional prospective study using the existing framework of
      the EBMT to identify and include patients. In 2006 560 patients with CML received an
      allotransplant, coming down from 800 in 2003. The percentage of patients transplanted not in
      first chronic phase is constantly increasing. Currently no data are available how many of
      those had previously been treated with 2nd generation TKI: it is however assumed, that also
      the number of patients transplanted after therapy with second generation TKI is increasing.

      An estimate number is that for the next three years approximately 1500 allotransplants for
      CML will be done. 60% of these pts (n=900) would have received 2nd generation TKI. Assuming
      that at least 50% of them will be registered in the non interventional prospective study, it
      is expected that up to 450 patients will be identified over the next three years.

      Patients response status to treatment with second line TKI (e.g. in stable CCyR, MCyR, or
      resistant to or progressing under 2nd line TKI) will be recorded to allow for identification
      of subgroups.

      Research variables:

        -  Patients' features

        -  Centres' features

        -  Initial diagnosis

        -  Subclassification and status of disease at start 2nd generation TKI

        -  Response status to treatment with 2nd generation TKI prior to SCT

        -  TKI treatment (dose; duration; response)

        -  Subclassification and status of disease at HSCT

        -  Complications

        -  Additional therapies

        -  Relapse or progression

        -  Last disease and patient status

        -  Donor

        -  Transplantation

        -  Graft manipulation

        -  Engraftment

        -  Comorbid conditions

        -  Preparative treatment

        -  Graft versus Host disease

        -  Follow up

      Data collection:

      All correspondence will go through the data centre in Leiden. The data manager from the
      selected centre will complete the study forms. The data manager from the selected centre,
      national registry or the Paris office will collect the data forms and will enter the MED-B
      specific items. The MED-C items will be collected and entered by the data centre in Leiden.
      Data analysis will be done centrally at the CLWP office.

      In case of inconsistencies a second check will be performed by a research assistant/data
      manager of the CLWP.
observational model: Cohort
time perspective: Prospective
measure: non-relapse mortality (NRM) (treatment related mortality)
time frame: 1 year after HSCT
measure: treatment related toxic effects
time frame: 2 year after HSCT
measure: overall survival
time frame: 2 years after HSCT
measure: Event Free Survival
time frame: 2 years after HSCT
measure: Relapse Rate
time frame: 2 years after HSCT
measure: outcome analyzed by response status to 2nd gen TKI prior to SCT
time frame: 2 year after HSCT
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Schleuning, MD
role: Principal Investigator
affiliation: Zentrum für Knochenmark und Blutstammzelltransplantation
last name: Eduardo Olavarria, MD
role: Study Chair
affiliation: Hospital de Navarra, Servicio de Hematologia, Pamplona, Spain
last name: Nicolaus kroeger, MD
role: Study Chair
affiliation: BMT Centre, University Hospital Eppendorf, Hamburg, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Finland
country: Germany
country: Hungary
country: Israel
country: Poland
country: Russian Federation
country: Saudi Arabia
country: United Kingdom
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive