<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/NCT03795909</url>
  </required_header>
  <id_info>
    <org_study_id>HLH-DR</org_study_id>
    <nct_id>NCT03795909</nct_id>
  </id_info>
  <brief_title>Ruxolitinib Combined With Dexamethasone for HLH</brief_title>
  <official_title>Ruxolitinib Combined With Dexamethasone for Pediatric Refractory and Secondary Hemophagocytic Lymphohistiocytosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Research Institute of Pediatrics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Research Institute of Pediatrics</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>
      A protocol named as &quot;HLH-DR&quot; for patients with refractory and secondary hemophagocytic&#xD;
      lymphohistiocytosismay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A modified protocol about ruxolitinib combined with dexamethasone which includes oral&#xD;
      ruxolitinib (2.5 mg twice daily for patients if the age&lt;14 years and the weight &lt;25kg，5 mg&#xD;
      twice daily for patients if the age&lt;14 years and the weight≥25kg, 10mg twice daily for&#xD;
      patients if the age ≥14 years and&lt;18 years）. Dexamethasone (10mg/m2.d) delayes for the first&#xD;
      2 weeks （form week 1 to 2），(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to&#xD;
      6），1.25mg/m2.d for week 7，and dropped off on week 8. Every 2 weeks, patients can be evaluated&#xD;
      based the diagnosed index&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2020</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>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of disease</measure>
    <time_frame>2 weeks</time_frame>
    <description>Serum ferritin&gt;2000ng/ml, disease actvie; serum ferritin&lt;2000ng/ml, disease control;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Axillary temperature</measure>
    <time_frame>2 weeks</time_frame>
    <description>36&lt;Axillary temperature&lt;37.2, disease control; 37.2&lt;Axillary temperature&lt;38.2, disease partly control; Axillary temperature&gt;38.2, disease active</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hemophagocytic Lymphohistiocytosis</condition>
  <arm_group>
    <arm_group_label>Ruxolitinib and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ruxolitinib 2.5 mg twice daily by oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo and Ruxolitinib</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sugar pill 2.5 mg twice daily by oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib</intervention_name>
    <description>Ruxolitinib （2.5 mg twice daily for patients if the age&lt;14 years and the weight &lt;25kg，5 mg twice daily for patients if the age&lt;14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and&lt;18 years）</description>
    <arm_group_label>Placebo and Ruxolitinib</arm_group_label>
    <arm_group_label>Ruxolitinib and Placebo</arm_group_label>
    <other_name>Jakafi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.</description>
    <arm_group_label>Placebo and Ruxolitinib</arm_group_label>
    <arm_group_label>Ruxolitinib and Placebo</arm_group_label>
    <other_name>Hormone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Secondary and refractory HLH.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family HLH.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Yue, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Institute of Pediatrics, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Yue, MD</last_name>
    <phone>8618515238169</phone>
    <phone_ext>8618515238169</phone_ext>
    <email>adaile123@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>xiaodong d Shi, MD</last_name>
    <phone>8613911601076</phone>
    <phone_ext>8618515238169</phone_ext>
    <email>18611196921@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yan Yue</name>
      <address>
        <city>Beijing</city>
        <state>Chaoyang District</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Yue, MD</last_name>
      <phone>8618515238169</phone>
      <phone_ext>8618515238169</phone_ext>
      <email>18611196921@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yan Yue, MD</last_name>
      <phone>8618515238169</phone>
      <phone_ext>8618515238169</phone_ext>
      <email>adaile123@sina.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jia Y Qin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yan Yue</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xiaodong Shi, MD</last_name>
      <phone>008613911601076</phone>
      <phone_ext>8618515238169</phone_ext>
      <email>adaile123@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Yan Yue, MD</last_name>
      <phone>8618515238169</phone>
      <phone_ext>8618515238169</phone_ext>
      <email>adaile123@sina.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 5, 2019</last_update_submitted>
  <last_update_submitted_qc>January 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Research Institute of Pediatrics</investigator_affiliation>
    <investigator_full_name>Yan Yue</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphohistiocytosis, Hemophagocytic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_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/NCT03795909
org study id: HLH-DR
nct id: NCT03795909
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A protocol named as "HLH-DR" for patients with refractory and secondary hemophagocytic
      lymphohistiocytosismay.
A modified protocol about ruxolitinib combined with dexamethasone which includes oral
      ruxolitinib (2.5 mg twice daily for patients if the age<14 years and the weight <25kg，5 mg
      twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for
      patients if the age ≥14 years and<18 years）. Dexamethasone (10mg/m2.d) delayes for the first
      2 weeks （form week 1 to 2），(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to
      6），1.25mg/m2.d for week 7，and dropped off on week 8. Every 2 weeks, patients can be evaluated
      based the diagnosed index
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Severity of disease
time frame: 2 weeks
description: Serum ferritin>2000ng/ml, disease actvie; serum ferritin<2000ng/ml, disease control;
measure: Axillary temperature
time frame: 2 weeks
description: 36<Axillary temperature<37.2, disease control; 37.2<Axillary temperature<38.2, disease partly control; Axillary temperature>38.2, disease active
arm group label: Ruxolitinib and Placebo
arm group type: Experimental
description: Ruxolitinib 2.5 mg twice daily by oral
arm group label: Placebo and Ruxolitinib
arm group type: Placebo Comparator
description: Sugar pill 2.5 mg twice daily by oral
intervention type: Drug
intervention name: Ruxolitinib
description: Ruxolitinib （2.5 mg twice daily for patients if the age<14 years and the weight <25kg，5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years）
arm group label: Placebo and Ruxolitinib
arm group label: Ruxolitinib and Placebo
other name: Jakafi
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.
arm group label: Placebo and Ruxolitinib
arm group label: Ruxolitinib and Placebo
other name: Hormone
criteria: 
gender: All
gender based: Yes
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Yan Yue, MD
role: Principal Investigator
affiliation: Capital Institute of Pediatrics, China
last name: Yan Yue, MD
phone: 8618515238169
phone ext: 8618515238169
email: adaile123@sina.com
last name: xiaodong d Shi, MD
phone: 8613911601076
phone ext: 8618515238169
email: 18611196921@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Research Institute of Pediatrics
investigator full name: Yan Yue
investigator title: Principal Investigator
mesh term: Lymphohistiocytosis, Hemophagocytic
mesh term: Dexamethasone