xml: <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/NCT06041893</url>
    </required_header>
    <id_info>
      <org_study_id>SMC 2023-03-094-002</org_study_id>
      <nct_id>NCT06041893</nct_id>
    </id_info>
    <brief_title>Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide</brief_title>
    <official_title>Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin and Low Dose Post-transplant Cyclophosphamide</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsung Medical Center</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>
        Aim of this study is to investigate the effect of early administration of anti-thymocyte&#xD;
        globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem&#xD;
        cell transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are&#xD;
        increasingly used in patients lacking a matched donor, but the optimal strategy needs to be&#xD;
        defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte&#xD;
        globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 29, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Actual">July 5, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Emgraftment Rate</measure>
      <time_frame>From the date of transplantation until 28 days after transplantation</time_frame>
      <description>cumulative incidence of donor-dominant engraftment by day 28 (by case)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Engraftment</measure>
      <time_frame>From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays</time_frame>
      <description>median time to neutrophil engraftment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Graft-Versus-Host Disease</measure>
      <time_frame>From the date of transplantation until 365 days after transplantation</time_frame>
      <description>Incidence of acute GVHD ≥ grade 2</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronic Graft-Versus-Host Disease</measure>
      <time_frame>From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation</time_frame>
      <description>Incidence of moderate to severe chronic GVHD</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of CMV infection</measure>
      <time_frame>From the date of transplantation until 365 days after transplantation</time_frame>
      <description>Rate of CMV infection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Hemorrhagic Cystitis</measure>
      <time_frame>From the date of transplantation until 365 days after transplantation</time_frame>
      <description>Rate of Hemorrhagic Cystitis</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Immune reconstitution</measure>
      <time_frame>From the date of transplantation until 365 days after transplantation</time_frame>
      <description>B cell, T cell (CD3+, CD4+, CD8+, Regulatory, Memory) NK cell count (of peripheral blood) at 1, 3, 6, 12 months post-transplantation</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Haploidentical Hematopoietic Stem Cell Transplantation</condition>
    <arm_group>
      <arm_group_label>ATG/LD-PTCy group</arm_group_label>
      <description>Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ATG-LDPTCy</intervention_name>
      <description>antithymocyte globulin with low dose post-transplant cyclophosphamide</description>
      <arm_group_label>ATG/LD-PTCy group</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        To confirm the recovery of immune function, T (including Treg, Tmemory), B, and NK cell&#xD;
        counts will be checked before hematopoietic stem cell transplantation and 1, 3, 6, and 12&#xD;
        months after transplantation.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and&#xD;
          low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics,&#xD;
          Samsung Medical Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG&#xD;
               and low-dose post-transplant cyclophosphamide conditioning at the department of&#xD;
               pediatrics, Samsung Medical Center.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A clinical trial subject (legal representative, if applicable) who do not consent or&#xD;
               is unable to give written consent.&#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>Keon Hee Yoo, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Samsung Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hee Young Ju</last_name>
      <phone>82-02-3410-0865</phone>
      <email>hyju320@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kyung Mi Kim</last_name>
      <phone>82-02-3410-3697</phone>
      <email>kmee.kim@sbri.co.kr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hee Young Ju</last_name>
        <phone>82-10-3410-0865</phone>
        <email>heeyoung.ju@samsung.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
      <investigator_full_name>KeonHee Yoo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>post transplant cyclophosphamide</keyword>
    <keyword>antithymocyte globulin</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041893
  org study id: SMC 2023-03-094-002
  nct id: NCT06041893
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim of this study is to investigate the effect of early administration of anti-thymocyte
        globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem
        cell transplantation.
  Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are
        increasingly used in patients lacking a matched donor, but the optimal strategy needs to be
        defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte
        globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.
  observational model: Case-Only
  time perspective: Prospective
  measure: Emgraftment Rate
  time frame: From the date of transplantation until 28 days after transplantation
  description: cumulative incidence of donor-dominant engraftment by day 28 (by case)
  measure: Time to Engraftment
  time frame: From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays
  description: median time to neutrophil engraftment
  measure: Acute Graft-Versus-Host Disease
  time frame: From the date of transplantation until 365 days after transplantation
  description: Incidence of acute GVHD ≥ grade 2
  measure: Chronic Graft-Versus-Host Disease
  time frame: From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation
  description: Incidence of moderate to severe chronic GVHD
  measure: Rate of CMV infection
  time frame: From the date of transplantation until 365 days after transplantation
  description: Rate of CMV infection
  measure: Rate of Hemorrhagic Cystitis
  time frame: From the date of transplantation until 365 days after transplantation
  description: Rate of Hemorrhagic Cystitis
  measure: Immune reconstitution
  time frame: From the date of transplantation until 365 days after transplantation
  description: B cell, T cell (CD3+, CD4+, CD8+, Regulatory, Memory) NK cell count (of peripheral blood) at 1, 3, 6, 12 months post-transplantation
  arm group label: ATG/LD-PTCy group
  description: Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center
  intervention type: Drug
  intervention name: ATG-LDPTCy
  description: antithymocyte globulin with low dose post-transplant cyclophosphamide
  arm group label: ATG/LD-PTCy group
  To confirm the recovery of immune function, T (including Treg, Tmemory), B, and NK cell
        counts will be checked before hematopoietic stem cell transplantation and 1, 3, 6, and 12
        months after transplantation.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Keon Hee Yoo, Professor
  role: Principal Investigator
  affiliation: Samsung Medical Center
  last name: Hee Young Ju
  phone: 82-02-3410-0865
  email: hyju320@gmail.com
  last name: Kyung Mi Kim
  phone: 82-02-3410-3697
  email: kmee.kim@sbri.co.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Samsung Medical Center
  investigator full name: KeonHee Yoo
  investigator title: Professor
  sharing ipd: Undecided