<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/NCT03252457</url>
  </required_header>
  <id_info>
    <org_study_id>DAC in ITP</org_study_id>
    <nct_id>NCT03252457</nct_id>
  </id_info>
  <brief_title>Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP</brief_title>
  <official_title>A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital of Medical College Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qingdao Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known&#xD;
      hospitals in China. In order to report the efficacy and safety of decitabine combining with&#xD;
      dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to&#xD;
      dexamethasone alone .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators anticipate to undertaking a parallel group, multicentre, randomised&#xD;
      controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the&#xD;
      participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive&#xD;
      days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms&#xD;
      by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given&#xD;
      intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2&#xD;
      weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d&#xD;
      for 4 consecutive days as a cycle, If platelet count remained below 30 × 109/L or there were&#xD;
      bleeding symptoms by day 10, an additional cycle of dexamethasone was given). Platelet count,&#xD;
      bleeding and other symptoms were evaluated before and after treatment, adverse events are&#xD;
      also recorded throughout the study in order to report the efficacy and safety of the&#xD;
      combination therapy compared to dexemathasone alone therapy for the treatment of adults with&#xD;
      ITP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of platelet response(continuous response rate)</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>Complete Response:a sustained (≥ 3 months) platelet count ≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count &lt; 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>therapy associated adverse events</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>The number and frequency of therapy associated adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Purpura, Thrombocytopenic, Idiopathic</condition>
  <condition>Immune Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>combination treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles</description>
    <arm_group_label>combination treatment group</arm_group_label>
    <other_name>pharmachemie</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.</description>
    <arm_group_label>combination treatment group</arm_group_label>
    <arm_group_label>single treatment group</arm_group_label>
    <other_name>Hydrocortisone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the diagnostic criteria for immune thrombocytopenia.&#xD;
&#xD;
          2. within 3 months fromdiagnosis,untreated patients, may be male or female, between the&#xD;
             ages of 18 ~ 80 years.&#xD;
&#xD;
          3. To show a platelet count &lt; 30×10^9/L, and with bleeding manifestations.&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts&#xD;
             within 3 months before the screening visit.&#xD;
&#xD;
          2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3&#xD;
             weeks prior to the start of the study.&#xD;
&#xD;
          3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.&#xD;
&#xD;
          4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or&#xD;
             uncontrolled disease or condition related to or impacting cardiac function (e.g.,&#xD;
             unstable angina, congestive heart failure, uncontrolled hypertension or cardiac&#xD;
             arrhythmia)&#xD;
&#xD;
          5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate&#xD;
             pregnancy during the study period.&#xD;
&#xD;
          6. Have a known diagnosis of other autoimmune diseases, established in the medical&#xD;
             history and laboratory findings with positive results for the determination of&#xD;
             antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct&#xD;
             Coombs test.&#xD;
&#xD;
          7. Patients who are deemed unsuitable for the study by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Hou, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Hou, Dr</last_name>
    <phone>+86-531-82169114</phone>
    <phone_ext>9879</phone_ext>
    <email>houming@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Qilu hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.</citation>
    <PMID>19005182</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhou H, Hou Y, Liu X, Qiu J, Feng Q, Wang Y, Zhang X, Min Y, Shao L, Liu X, Li G, Li L, Yang L, Xu S, Ni H, Peng J, Hou M. Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia. Thromb Haemost. 2015 May;113(5):1021-34. doi: 10.1160/TH14-04-0342. Epub 2015 Jan 8.</citation>
    <PMID>25566808</PMID>
  </results_reference>
  <results_reference>
    <citation>Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;127(3):296-302; quiz 370. doi: 10.1182/blood-2015-07-659656. Epub 2015 Oct 19.</citation>
    <PMID>26480931</PMID>
  </results_reference>
  <results_reference>
    <citation>Din B, Wang X, Shi Y, Li Y. Long-term effect of high-dose dexamethasone with or without low-dose dexamethasone maintenance in untreated immune thrombocytopenia. Acta Haematol. 2015;133(1):124-8. doi: 10.1159/000362529. Epub 2014 Sep 20.</citation>
    <PMID>25247485</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <keyword>Purpura</keyword>
  <keyword>Thrombocytopenia</keyword>
  <keyword>immune throbocytopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Decitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03252457
org study id: DAC in ITP
nct id: NCT03252457
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known
      hospitals in China. In order to report the efficacy and safety of decitabine combining with
      dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to
      dexamethasone alone .
The investigators anticipate to undertaking a parallel group, multicentre, randomised
      controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the
      participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive
      days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms
      by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given
      intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2
      weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d
      for 4 consecutive days as a cycle, If platelet count remained below 30 × 109/L or there were
      bleeding symptoms by day 10, an additional cycle of dexamethasone was given). Platelet count,
      bleeding and other symptoms were evaluated before and after treatment, adverse events are
      also recorded throughout the study in order to report the efficacy and safety of the
      combination therapy compared to dexemathasone alone therapy for the treatment of adults with
      ITP.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of platelet response(continuous response rate)
time frame: up to 1 year per subject
description: Complete Response:a sustained (≥ 3 months) platelet count ≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
measure: therapy associated adverse events
time frame: up to 1 year per subject
description: The number and frequency of therapy associated adverse events
arm group label: combination treatment group
arm group type: Experimental
description: 100 enrolled patients are randomly picked up to take decitabine in combination with dexamethasone at the indicated dose
arm group label: single treatment group
arm group type: Active Comparator
description: 100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose
intervention type: Drug
intervention name: Decitabine
description: given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles
arm group label: combination treatment group
other name: pharmachemie
intervention type: Drug
intervention name: Dexamethasone
description: given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.
arm group label: combination treatment group
arm group label: single treatment group
other name: Hydrocortisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Hou, Dr
role: Principal Investigator
affiliation: Shandong University
last name: Ming Hou, Dr
phone: +86-531-82169114
phone ext: 9879
email: houming@medmail.com.cn
facility: 
country: China
citation: Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
PMID: 19005182
citation: Zhou H, Hou Y, Liu X, Qiu J, Feng Q, Wang Y, Zhang X, Min Y, Shao L, Liu X, Li G, Li L, Yang L, Xu S, Ni H, Peng J, Hou M. Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia. Thromb Haemost. 2015 May;113(5):1021-34. doi: 10.1160/TH14-04-0342. Epub 2015 Jan 8.
PMID: 25566808
citation: Wei Y, Ji XB, Wang YW, Wang JX, Yang EQ, Wang ZC, Sang YQ, Bi ZM, Ren CA, Zhou F, Liu GQ, Peng J, Hou M. High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial. Blood. 2016 Jan 21;127(3):296-302; quiz 370. doi: 10.1182/blood-2015-07-659656. Epub 2015 Oct 19.
PMID: 26480931
citation: Din B, Wang X, Shi Y, Li Y. Long-term effect of high-dose dexamethasone with or without low-dose dexamethasone maintenance in untreated immune thrombocytopenia. Acta Haematol. 2015;133(1):124-8. doi: 10.1159/000362529. Epub 2014 Sep 20.
PMID: 25247485
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Thrombocytopenia
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic, Idiopathic
mesh term: Purpura, Thrombocytopenic
mesh term: Dexamethasone
mesh term: Hydrocortisone
mesh term: Decitabine
sharing ipd: No