<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/NCT01728389</url>
  </required_header>
  <id_info>
    <org_study_id>IBT-COI-01</org_study_id>
    <nct_id>NCT01728389</nct_id>
  </id_info>
  <brief_title>Intrabone Transplantation of Allogenic Peripheral Blood Stem Cells in Patients With Myeloid and Lymphoid Malignancies.</brief_title>
  <official_title>Efficacy and Safety of Direct Intrabone Transplantation of Peripheral Blood Haematopoietic Stem Cells Form HLA-matched Sibling Donors in Patients With Myeloid and Lymphoid Malignancies.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Sklodowska-Curie National Research Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maria Sklodowska-Curie National Research Institute of Oncology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate efficacy and safety of direct intrabone&#xD;
      transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched&#xD;
      sibling donors in patients with myeloid and lymphoid malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allogenic haematopoietic stem cell transplantation is an established treatment option for&#xD;
      haematologic malignancies, especially leukaemias and lymphomas, providing curative potential.&#xD;
      The optimal donor is HLA-matched sibling and G-CSF stimulated peripheral blood is nowadays&#xD;
      the most common source of stem cells. Routinely used route of stem cell transplantation is&#xD;
      intravenous infusion via central venous catheter. Based on the animal studies, only 10-15% of&#xD;
      intravenously transplanted stem cells migrate to haematopoietic sites while the rest is lost&#xD;
      in other organs. Results of studies of direct intrabone allogenic cord-blood cells&#xD;
      transplantation in humans confirm that this route of transplantation is associated with less&#xD;
      probability of graft failure and moreover may reduce risk of graft-versus-host disease and&#xD;
      malignancy relapse. For those purposes in the current study we investigate intrabone route of&#xD;
      allogenic peripheral blood stem cell transplantation. Our intention is to achieve fast&#xD;
      engraftment and minimize risk of relapse and graft graft-versus-host disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">April 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neutrophil engraftment (ANC &gt; 0,5 G/l)</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lineage chimerism of peripheral blood T-cell lymphocytes</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet engraftment (Plt &gt; 20 G/l)</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse reactions related with intrabone transplantation procedure</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Relapse incidence</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Graft-versus-host disease incidence</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Leukemia</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Intrabone transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrabone transplantation</intervention_name>
    <description>Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.</description>
    <arm_group_label>Intrabone transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-55 years&#xD;
&#xD;
          -  Diagnosis of leukaemia or lymphoma&#xD;
&#xD;
          -  Indication for allogenic stem cell transplantation according to European Group for&#xD;
             Blood and Marrow Transplantation guidelines&#xD;
&#xD;
          -  HLA-matched sibling donor qualified for peripheral blood stem cell donation&#xD;
&#xD;
          -  Performance status WHO 0-1&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine &gt;1.5 upper normal&#xD;
             limit; LVEF &lt;45%&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Unstable diabetes&#xD;
&#xD;
          -  Psychiatric diseases&#xD;
&#xD;
          -  Obesity or anatomical obstacle for direct intrabone transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz Czerw, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tomasz Czerw, MD</last_name>
    <phone>+48 32 2788523</phone>
    <email>tomcmed@poczta.onet.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sebastian Giebel, MD</last_name>
    <phone>+48 32 2788523</phone>
    <email>sgiebel@io.gliwice.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>MSC Memorial CAncer Center and Institute of Oncology</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastian Giebel, Assoc. prof.</last_name>
      <phone>+48322788523</phone>
      <email>ots@io.gliwice.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Frassoni F, Gualandi F, Podesta M, Raiola AM, Ibatici A, Piaggio G, Sessarego M, Sessarego N, Gobbi M, Sacchi N, Labopin M, Bacigalupo A. Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study. Lancet Oncol. 2008 Sep;9(9):831-9. doi: 10.1016/S1470-2045(08)70180-3. Epub 2008 Aug 8.</citation>
    <PMID>18693069</PMID>
  </reference>
  <reference>
    <citation>Okada M, Yoshihara S, Taniguchi K, Kaida K, Ikegame K, Kato R, Tamaki H, Inoue T, Soma T, Kai S, Kato S, Ogawa H. Intrabone marrow transplantation of unwashed cord blood using reduced-intensity conditioning treatment: a phase I study. Biol Blood Marrow Transplant. 2012 Apr;18(4):633-9. doi: 10.1016/j.bbmt.2011.08.010. Epub 2011 Aug 23.</citation>
    <PMID>21867667</PMID>
  </reference>
  <reference>
    <citation>Massollo M, Podesta M, Marini C, Morbelli S, Cassanelli C, Pinto V, Ubezio G, Curti G, Uccelli A, Frassoni F, Sambuceti G. Contact with the bone marrow microenvironment readdresses the fate of transplanted hematopoietic stem cells. Exp Hematol. 2010 Oct;38(10):968-77. doi: 10.1016/j.exphem.2010.06.003. Epub 2010 Jun 13.</citation>
    <PMID>20550953</PMID>
  </reference>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>July 23, 2013</last_update_submitted>
  <last_update_submitted_qc>July 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>allogenic stem cell transplantation</keyword>
  <keyword>peripheral blood stem cells</keyword>
  <keyword>intrabone</keyword>
  <keyword>intra-bone</keyword>
  <keyword>leukemia</keyword>
  <keyword>lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</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/NCT01728389
org study id: IBT-COI-01
nct id: NCT01728389
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate efficacy and safety of direct intrabone
      transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched
      sibling donors in patients with myeloid and lymphoid malignancies.
Allogenic haematopoietic stem cell transplantation is an established treatment option for
      haematologic malignancies, especially leukaemias and lymphomas, providing curative potential.
      The optimal donor is HLA-matched sibling and G-CSF stimulated peripheral blood is nowadays
      the most common source of stem cells. Routinely used route of stem cell transplantation is
      intravenous infusion via central venous catheter. Based on the animal studies, only 10-15% of
      intravenously transplanted stem cells migrate to haematopoietic sites while the rest is lost
      in other organs. Results of studies of direct intrabone allogenic cord-blood cells
      transplantation in humans confirm that this route of transplantation is associated with less
      probability of graft failure and moreover may reduce risk of graft-versus-host disease and
      malignancy relapse. For those purposes in the current study we investigate intrabone route of
      allogenic peripheral blood stem cell transplantation. Our intention is to achieve fast
      engraftment and minimize risk of relapse and graft graft-versus-host disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neutrophil engraftment (ANC > 0,5 G/l)
time frame: 28 days
measure: Lineage chimerism of peripheral blood T-cell lymphocytes
time frame: 1 year
measure: Platelet engraftment (Plt > 20 G/l)
time frame: 28 days
measure: Adverse reactions related with intrabone transplantation procedure
time frame: 28 days
measure: Relapse incidence
time frame: 1 year
measure: Overall survival
time frame: 1 year
measure: Disease-free survival
time frame: 1 year
measure: Graft-versus-host disease incidence
time frame: 1 year
arm group label: Intrabone transplantation
arm group type: Experimental
description: Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
intervention type: Procedure
intervention name: Intrabone transplantation
description: Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
arm group label: Intrabone transplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Tomasz Czerw, MD
role: Principal Investigator
affiliation: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
last name: Tomasz Czerw, MD
phone: +48 32 2788523
email: tomcmed@poczta.onet.pl
last name: Sebastian Giebel, MD
phone: +48 32 2788523
email: sgiebel@io.gliwice.pl
facility: 
status: Recruiting
contact: 
country: Poland
citation: Frassoni F, Gualandi F, Podesta M, Raiola AM, Ibatici A, Piaggio G, Sessarego M, Sessarego N, Gobbi M, Sacchi N, Labopin M, Bacigalupo A. Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study. Lancet Oncol. 2008 Sep;9(9):831-9. doi: 10.1016/S1470-2045(08)70180-3. Epub 2008 Aug 8.
PMID: 18693069
citation: Okada M, Yoshihara S, Taniguchi K, Kaida K, Ikegame K, Kato R, Tamaki H, Inoue T, Soma T, Kai S, Kato S, Ogawa H. Intrabone marrow transplantation of unwashed cord blood using reduced-intensity conditioning treatment: a phase I study. Biol Blood Marrow Transplant. 2012 Apr;18(4):633-9. doi: 10.1016/j.bbmt.2011.08.010. Epub 2011 Aug 23.
PMID: 21867667
citation: Massollo M, Podesta M, Marini C, Morbelli S, Cassanelli C, Pinto V, Ubezio G, Curti G, Uccelli A, Frassoni F, Sambuceti G. Contact with the bone marrow microenvironment readdresses the fate of transplanted hematopoietic stem cells. Exp Hematol. 2010 Oct;38(10):968-77. doi: 10.1016/j.exphem.2010.06.003. Epub 2010 Jun 13.
PMID: 20550953
responsible party type: Sponsor
mesh term: Leukemia