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/NCT06000982</url>
    </required_header>
    <id_info>
      <org_study_id>PTCY40-50</org_study_id>
      <nct_id>NCT06000982</nct_id>
    </id_info>
    <brief_title>Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis</brief_title>
    <official_title>A Comparison Study of Reduced Dose of Post-transplantation Cyclophosphamide (PTCy 40mg/kg) Versus Standard (PTCY 50mg/kg): a Multi-center Study for Halo-identical Donor Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Jiao Tong University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Clinical Research Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Jiao Tong University School of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease&#xD;
        (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard&#xD;
        dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG)&#xD;
        achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of&#xD;
        PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a&#xD;
        multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD&#xD;
        prophylaxis of PTCy 40 versus 50.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease&#xD;
        (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard&#xD;
        dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG)&#xD;
        achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg)&#xD;
        was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was&#xD;
        similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our&#xD;
        observation, in this study, a prospective multiple-center randomized comparison is planned to&#xD;
        evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD&#xD;
        prophylaxis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>acute GVHD (grade II-IV)</measure>
      <time_frame>day 100</time_frame>
      <description>clinical documentation of grade II-IV aGVHD</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Non-relapse mortality</measure>
      <time_frame>1 year</time_frame>
      <description>Death without documentation of disease relapse or progression (bone marrow &gt;5% or with extra medullary diseases)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>chronic GVHD</measure>
      <time_frame>1 year</time_frame>
      <description>incidence of patients with clinical documentation of chronic GVHD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall survival</measure>
      <time_frame>1 year</time_frame>
      <description>Event defined as death of any causes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>1 year</time_frame>
      <description>Event defined as death of any causes and disease relapse or progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival without relapse and moderate to severe GVHD</measure>
      <time_frame>1 year</time_frame>
      <description>Rate of patients remain alive without disease relapse or progression (bone marrow blast &gt;5% or extra medullary diseases) and without documentation of grade III-IV acute GVHD and moderate to severe chronic GVHD</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>GVHD</condition>
    <arm_group>
      <arm_group_label>PTCy-40</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive 40mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PTCy-50</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive 50mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PTCY</intervention_name>
      <description>PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis</description>
      <arm_group_label>PTCy-40</arm_group_label>
      <arm_group_label>PTCy-50</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with hematological malignancies&#xD;
  &#xD;
            -  Patients undergo allogeneic stem cell transplantation from haplo-identical donors&#xD;
  &#xD;
            -  Patents with informed consent provided&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with active infection ()bacteria, fungal or viral)&#xD;
  &#xD;
            -  Patients with liver, renal and cardiac dysfunction not suitable for undergoing&#xD;
               allogeneic stem cell transplantation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>chun Wang</last_name>
      <role>Study Director</role>
      <affiliation>Zhaxin Hospital, Go Broad Health Care</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>chun Wang</last_name>
      <phone>8613386259777</phone>
      <email>wangchunsh@medmail.com.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shenzhen People's Hospital</name>
        <address>
          <city>Shenzhen</city>
          <state>GaungDong</state>
          <zip>518000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Rui Jin Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
      <investigator_full_name>Jiong HU</investigator_full_name>
      <investigator_title>Deputy director, department of hematology</investigator_title>
    </responsible_party>
    <keyword>graft versus host disease (GVHD)</keyword>
    <keyword>post-transplantation cyclophosphamide (PTCy)</keyword>
    <keyword>allogeneic stem cell transplantation</keyword>
    <keyword>haplo-identical donor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Graft vs Host Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT06000982
  org study id: PTCY40-50
  nct id: NCT06000982
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease
        (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard
        dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG)
        achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of
        PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a
        multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD
        prophylaxis of PTCy 40 versus 50.
  Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease
        (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard
        dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG)
        achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg)
        was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was
        similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our
        observation, in this study, a prospective multiple-center randomized comparison is planned to
        evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD
        prophylaxis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: acute GVHD (grade II-IV)
  time frame: day 100
  description: clinical documentation of grade II-IV aGVHD
  measure: Non-relapse mortality
  time frame: 1 year
  description: Death without documentation of disease relapse or progression (bone marrow >5% or with extra medullary diseases)
  measure: chronic GVHD
  time frame: 1 year
  description: incidence of patients with clinical documentation of chronic GVHD
  measure: overall survival
  time frame: 1 year
  description: Event defined as death of any causes
  measure: Disease-free survival
  time frame: 1 year
  description: Event defined as death of any causes and disease relapse or progression
  measure: Survival without relapse and moderate to severe GVHD
  time frame: 1 year
  description: Rate of patients remain alive without disease relapse or progression (bone marrow blast >5% or extra medullary diseases) and without documentation of grade III-IV acute GVHD and moderate to severe chronic GVHD
  arm group label: PTCy-40
  arm group type: Experimental
  description: Patients receive 40mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.
  arm group label: PTCy-50
  arm group type: Active Comparator
  description: Patients receive 50mg/kg PTCY (day+3 and +4) with tacrolimus from day+5 and low-dose ATG of 2,5mg/kg 72 hours after documentation neutrophil engraftment.
  intervention type: Drug
  intervention name: PTCY
  description: PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis
  arm group label: PTCy-40
  arm group label: PTCy-50
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: chun Wang
  role: Study Director
  affiliation: Zhaxin Hospital, Go Broad Health Care
  last name: chun Wang
  phone: 8613386259777
  email: wangchunsh@medmail.com.cn
  facility: 
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Jiao Tong University School of Medicine
  investigator full name: Jiong HU
  investigator title: Deputy director, department of hematology
  mesh term: Graft vs Host Disease