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/NCT06038422</url>
    </required_header>
    <id_info>
      <org_study_id>BFH20230717001</org_study_id>
      <nct_id>NCT06038422</nct_id>
    </id_info>
    <brief_title>GTP Regimen in the Treatment of Refractory/Recurrent HLH</brief_title>
    <official_title>Clinical Study on Efficacy and Safety of GTP Regimen in the Treatment of Refractory/Recurrent Hemophagocytic Lymphohistiocytosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Friendship Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about efficacy and safety of GTP regimen in&#xD;
        refractory/recurrent hemophagocytic lymphohistiocytosis. The main questions it aims to answer&#xD;
        are:&#xD;
  &#xD;
          -  Overall remission rate of GTP regimen in R/R HLH&#xD;
  &#xD;
          -  Adverse effect of GTP regimen Participants will be treated with GTP regimen&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Refractory/recurrent hemophagocytic lymphohistiocytosis will be treated with emapalumab&#xD;
        combined with teniposide and methylprednisolone. Observed the overall response rate and side&#xD;
        effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2024</primary_completion_date>
    <phase>Phase 3</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>ORR</measure>
      <time_frame>1 year</time_frame>
      <description>Overall remission rate</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Refractory</condition>
    <condition>Recurrence</condition>
    <condition>Hemophagocytic Lymphohistiocytosis</condition>
    <arm_group>
      <arm_group_label>GTP regimen treated patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>R/R HLH patients treated with GTP regimen</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GTP regimen</intervention_name>
      <description>Refractory/recurrent hemophagocytic lymphohistiocytosis patients will be treated with GTP regimen (Emapalumab+Teniposide+Methylprednisolone)</description>
      <arm_group_label>GTP regimen treated patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female patients ≥1 month of age with HLH&#xD;
  &#xD;
            2. Definitive diagnosis of HLH: meets the molecular diagnosis of pHLH or has a family&#xD;
               history of HLH, or meets at least 5 of the 8 diagnostic criteria of HLH-2004.&#xD;
  &#xD;
            3. The investigators assessed the presence of refractory/recurrent HLH disease. Patients&#xD;
               must meet one of the following criteria assessed by the investigator:&#xD;
  &#xD;
                 -  Previous conventional HLH treatment did not respond.&#xD;
  &#xD;
                 -  The patients were not satisfied with the efficacy of conventional HLH treatment&#xD;
                    or their condition worsened.&#xD;
  &#xD;
                 -  HLH reactivation occurs. Reactivation is defined as: worsening of two or more HLH&#xD;
                    clinical and laboratory criteria (after initial remission).&#xD;
  &#xD;
            4. According to the researchers, the expected survival was more than 2 weeks.&#xD;
  &#xD;
            5. The informed consent is signed by the patient or his legal guardian (patients under 18&#xD;
               years), or by the patient's legally authorized representative.&#xD;
  &#xD;
            6. Women who are fertile are willing to use a highly effective contraceptive method from&#xD;
               the start of the study until 6 months after the end of the last course of treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. There is active mycobacterium, histoplasma capsulatus, Salmonella, or leishmania&#xD;
               infection.&#xD;
  &#xD;
            2. There is uncontrolled active gastrointestinal bleeding.&#xD;
  &#xD;
            3. The investigator believes that there are any serious comorbidities or any other&#xD;
               conditions that make the patient unsuitable for treatment.&#xD;
  &#xD;
            4. A history of hypersensitivity or hypersensitivity to any component of the drug in the&#xD;
               study protocol, such as polysorbate.&#xD;
  &#xD;
            5. Had received the BCG vaccine within 12 weeks prior to screening.&#xD;
  &#xD;
            6. Have received live or attenuated vaccine (except BCG) within 4 weeks prior to&#xD;
               screening.&#xD;
  &#xD;
            7. Pregnancy patients.&#xD;
  &#xD;
            8. Within 4 weeks prior to enrollment in this study, another concurrent clinical&#xD;
               intervention study was enrolled.&#xD;
  &#xD;
            9. There is any condition or circumstance that the investigator believes may cause the&#xD;
               patient to be unable to complete the study or to comply with study procedures or&#xD;
               requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Zhao Wang</investigator_full_name>
      <investigator_title>director of department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphohistiocytosis, Hemophagocytic</mesh_term>
      <mesh_term>Recurrence</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/NCT06038422
  org study id: BFH20230717001
  nct id: NCT06038422
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about efficacy and safety of GTP regimen in
        refractory/recurrent hemophagocytic lymphohistiocytosis. The main questions it aims to answer
        are:
  
          -  Overall remission rate of GTP regimen in R/R HLH
  
          -  Adverse effect of GTP regimen Participants will be treated with GTP regimen
  Refractory/recurrent hemophagocytic lymphohistiocytosis will be treated with emapalumab
        combined with teniposide and methylprednisolone. Observed the overall response rate and side
        effects.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ORR
  time frame: 1 year
  description: Overall remission rate
  arm group label: GTP regimen treated patients
  arm group type: Experimental
  description: R/R HLH patients treated with GTP regimen
  intervention type: Drug
  intervention name: GTP regimen
  description: Refractory/recurrent hemophagocytic lymphohistiocytosis patients will be treated with GTP regimen (Emapalumab+Teniposide+Methylprednisolone)
  arm group label: GTP regimen treated patients
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Beijing Friendship Hospital
  investigator full name: Zhao Wang
  investigator title: director of department
  mesh term: Lymphohistiocytosis, Hemophagocytic
  mesh term: Recurrence