<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/NCT01683123</url>
  </required_header>
  <id_info>
    <org_study_id>get-buf-2010-02</org_study_id>
    <nct_id>NCT01683123</nct_id>
  </id_info>
  <brief_title>Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT</brief_title>
  <acronym>BUFLU</acronym>
  <official_title>Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol de trasplantes hematopoyeticos y terapia celular</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Espanol de trasplantes hematopoyeticos y terapia celular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine&#xD;
      in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40&#xD;
      mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan&#xD;
      3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan&#xD;
      pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in&#xD;
      the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or&#xD;
      peripheral blood of HLA identical sibling donors are not manipulated in their cellular&#xD;
      content before transplantation. Blood products were leukocyte depleted and irradiated before&#xD;
      transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics,&#xD;
      antimicrobial agents and growth factors use are followed according to standard procedures.&#xD;
&#xD;
      The main objectives are to record data regarding engraftment, regimen related toxicity and&#xD;
      outcome in different patient populations according to age, disease type, disease status at&#xD;
      HSCT and comorbidities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2007</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">143</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Myeloproliferative Disorders</condition>
  <condition>Chronic Myeloid Leukemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with myeloid malignancies submitted to allogeneic HSCT with an HLA identical sibling&#xD;
        donor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Myeloid Leukemia&#xD;
&#xD;
          -  Myelodysplastic Syndrome&#xD;
&#xD;
          -  Myeloproliferative Disorders&#xD;
&#xD;
          -  Chronic Myeloid Leukemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Performance status ECOG&gt;2&#xD;
&#xD;
          -  Cardiomyopathy (LVEF &lt;39%)&#xD;
&#xD;
          -  Pulmonary dysfunction (DLCO&lt;39%)&#xD;
&#xD;
          -  Hepatic dysfunction Grade &gt;1&#xD;
&#xD;
          -  Renal dysfunction Grade &gt;1 (Creatinine &gt; 1.6 mg/dl)&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Other active neoplasm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier De la Serna, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grupo Espanol de trasplantes hematopoyeticos y terapia celular</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guillermo Sanz, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Grupo Espanol de trasplantes hematopoyeticos y terapia celular</affiliation>
  </overall_official>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allogeneic HSCT</keyword>
  <keyword>Busulfan</keyword>
  <keyword>Fludarabina</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>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Myeloproliferative Disorders</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/NCT01683123
org study id: get-buf-2010-02
nct id: NCT01683123
lead sponsor: 
has dmc: Yes
Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine
      in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.
In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40
      mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan
      3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan
      pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in
      the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or
      peripheral blood of HLA identical sibling donors are not manipulated in their cellular
      content before transplantation. Blood products were leukocyte depleted and irradiated before
      transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics,
      antimicrobial agents and growth factors use are followed according to standard procedures.

      The main objectives are to record data regarding engraftment, regimen related toxicity and
      outcome in different patient populations according to age, disease type, disease status at
      HSCT and comorbidities.
observational model: Other
time perspective: Retrospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Javier De la Serna, MD
role: Principal Investigator
affiliation: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
last name: Guillermo Sanz, MD
role: Study Chair
affiliation: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Myelodysplastic Syndromes
mesh term: Myeloproliferative Disorders