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/NCT06034535</url>
    </required_header>
    <id_info>
      <org_study_id>HKCH-REC-2022-002</org_study_id>
      <nct_id>NCT06034535</nct_id>
    </id_info>
    <brief_title>CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation</brief_title>
    <official_title>CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hong Kong Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hong Kong Children's Hospital</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>
        In this clinical trial, we aim to apply CD62L depleted donor lymphocyte infusion (DLI)&#xD;
        together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation&#xD;
        (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. We shall&#xD;
        evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year,&#xD;
        frequency of adverse events and post-transplant complications, and immunoreconstitution.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The peripheral stem cell harvest product from the patient's related haploidential donor will&#xD;
        be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and&#xD;
        the other portion will undergo CD62L depletion. Both depleted products will be infused&#xD;
        intravenously to the patient on the same day.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>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>Graft failure-free, GVHD-free survival</measure>
      <time_frame>up to 1 year</time_frame>
      <description>From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>up to 1 year</time_frame>
      <description>From the date of treatment start until the date of death from any cause, assessed up to 1 year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who develop relapse among those with malignant diseases</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who develop graft failure</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Graft failure is defined as donor cells &lt;5% in whole blood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who develop infection</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Any microbiologically documented infections are included</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who develop acute graft-versus-host disease</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Acute graft-versus-host disease is defined by MAGIC criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who develop chronic graft-versus-host disease</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Chronic graft-versus-host disease is defined by NIH criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who develop adverse events not mentioned in outcomes 4-7</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood T lymphocyte count at 3 months</measure>
      <time_frame>at 3 months</time_frame>
      <description>Mean T lymphocyte count in blood among evaluable patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood T lymphocyte count at 1 year</measure>
      <time_frame>at 1 year</time_frame>
      <description>Mean T lymphocyte count in blood among evaluable patients</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">23</enrollment>
    <condition>Hematopoietic Organs; Disorder</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CD62L depleted donor lymphocyte infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>CD62L depleted donor lymphocyte infusion</intervention_name>
      <description>Intravenous infusion of CD62L depleted donor lymphocytes</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient who requires allogeneic hematopoietic stem cell transplant, has no human&#xD;
               leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.&#xD;
  &#xD;
            -  Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy&#xD;
  &#xD;
            -  Karnofsky or Lansky performance status score ≥50&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating woman&#xD;
  &#xD;
            -  HIV infection&#xD;
  &#xD;
            -  Patients for whom alternative treatment is deemed more appropriate by treating&#xD;
               physician&#xD;
  &#xD;
            -  Patients who are unlikely to benefit from haploidentical hematopoietic stem cell&#xD;
               transplantation, e.g., terminal malignancy with multiorgan failure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Cheuk</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hong Kong Children's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniel Cheuk</last_name>
      <phone>85235136049</phone>
      <email>cheukkld@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hong Kong Children's Hospital</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Cheuk</last_name>
        <phone>852-35136049</phone>
        <email>cheukkld@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hong Kong Children's Hospital</investigator_affiliation>
      <investigator_full_name>Cheuk Ka Leung Daniel</investigator_full_name>
      <investigator_title>Consultant</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</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/NCT06034535
  org study id: HKCH-REC-2022-002
  nct id: NCT06034535
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this clinical trial, we aim to apply CD62L depleted donor lymphocyte infusion (DLI)
        together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation
        (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. We shall
        evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year,
        frequency of adverse events and post-transplant complications, and immunoreconstitution.
  The peripheral stem cell harvest product from the patient's related haploidential donor will
        be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and
        the other portion will undergo CD62L depletion. Both depleted products will be infused
        intravenously to the patient on the same day.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Graft failure-free, GVHD-free survival
  time frame: up to 1 year
  description: From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year
  measure: Overall survival
  time frame: up to 1 year
  description: From the date of treatment start until the date of death from any cause, assessed up to 1 year
  measure: Proportion of patients who develop relapse among those with malignant diseases
  time frame: up to 1 year
  description: Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission
  measure: Proportion of patients who develop graft failure
  time frame: up to 1 year
  description: Graft failure is defined as donor cells <5% in whole blood
  measure: Proportion of patients who develop infection
  time frame: up to 1 year
  description: Any microbiologically documented infections are included
  measure: Proportion of patients who develop acute graft-versus-host disease
  time frame: up to 1 year
  description: Acute graft-versus-host disease is defined by MAGIC criteria
  measure: Proportion of patients who develop chronic graft-versus-host disease
  time frame: up to 1 year
  description: Chronic graft-versus-host disease is defined by NIH criteria
  measure: Proportion of patients who develop adverse events not mentioned in outcomes 4-7
  time frame: up to 1 year
  description: Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)
  measure: Blood T lymphocyte count at 3 months
  time frame: at 3 months
  description: Mean T lymphocyte count in blood among evaluable patients
  measure: Blood T lymphocyte count at 1 year
  time frame: at 1 year
  description: Mean T lymphocyte count in blood among evaluable patients
  arm group label: Treatment
  arm group type: Experimental
  description: CD62L depleted donor lymphocyte infusion
  intervention type: Biological
  intervention name: CD62L depleted donor lymphocyte infusion
  description: Intravenous infusion of CD62L depleted donor lymphocytes
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: No
  last name: Daniel Cheuk
  role: Principal Investigator
  affiliation: Hong Kong Children's Hospital
  last name: Daniel Cheuk
  phone: 85235136049
  email: cheukkld@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Hong Kong Children's Hospital
  investigator full name: Cheuk Ka Leung Daniel
  investigator title: Consultant
  sharing ipd: No