<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/NCT04446130</url>
  </required_header>
  <id_info>
    <org_study_id>DAC-HAAG-03</org_study_id>
    <nct_id>NCT04446130</nct_id>
  </id_info>
  <brief_title>Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients</brief_title>
  <official_title>A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Henan Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changzhou No.2 People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second People's Hospital of Huai'an</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Affiliated Hospital of Soochow University</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 purpose of this study is to evaluate the efficacy and safety of decitabine combined with&#xD;
      HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and&#xD;
      ALL/LBL with myeloid or stem cell markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 3, open label, single arm, multi-center study in newly diagnosed ETP-ALL/LBL,&#xD;
      T/M-MPAL and ALL/LBL patients who have myeloid or stem cell markers. The patients will&#xD;
      receive decitabine combined with HAAG regimen in the induction treatment. The patients who&#xD;
      respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional&#xD;
      allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance&#xD;
      treatment with decitabine according to patient's wishes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</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>Overall Response Rate (ORR)</measure>
    <time_frame>Day 28-35 of induction course</time_frame>
    <description>ORR includes complete remission (CR), CR with incomplete hematologic recovery (CRi) and partial remission (PR). CR was defined as &lt; 5% bone marrow blasts in an aspirate with spicules and independent of transfusions; CRi: was defined as&lt;5% bone marrow blasts, either ANC&lt;1×10^9/L or platelets&lt;100×10^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>4 years</time_frame>
    <description>time from randomization to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukemia-free survival (LFS)</measure>
    <time_frame>4 years</time_frame>
    <description>time from randomization to the first relapse or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse(CIR)</measure>
    <time_frame>4 years</time_frame>
    <description>time from achievement of a remmission to the first relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>3 years</time_frame>
    <description>adverse events are evaluated with CTCAE V5.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Induction Chemotherapy</condition>
  <condition>Acute T-Lymphocytic Leukemia</condition>
  <condition>T-cell Lymphoblastic Lymphoma Leukemia</condition>
  <condition>T-cell/Myeloid Mixed Phenotype Acute Leukemia</condition>
  <arm_group>
    <arm_group_label>Decitabine combined with HAAG Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed T-ALL/LBL and T/M-MPAL patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine combined with HAAG Regimen</intervention_name>
    <description>Decitabine :20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine :1mg/d,d3~16,intravenous infusion; Aclarubicin :10mg/d, d3~d10, intravenous infusion; Cytarabine :10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection</description>
    <arm_group_label>Decitabine combined with HAAG Regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed ETP-ALL/LBL, T/M-MPAL according to the 2016 revision to the WHO&#xD;
             classification of myeloid neoplasms and acute leukemia, and T-ALL/LBL with one or more&#xD;
             of the myeloid or stem cell markers (CD34, CD117, HLADR, CD13, CD33, CD11b or CD65) on&#xD;
             at least 25% of lymphoblasts.&#xD;
&#xD;
          2. Age 15-60.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) score: 0-2.&#xD;
&#xD;
          4. No history of previous chemotherapy or target therapy.&#xD;
&#xD;
          5. Provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with another malignant disease.&#xD;
&#xD;
          2. Patients has participated in or participating in other clinical trials.&#xD;
&#xD;
          3. Patients with uncontrolled active infection.&#xD;
&#xD;
          4. Patients with left ventricular ejection fraction &lt; 0.5 by echocardiography or grade&#xD;
             III/IV cardiovascular dysfunction according to the New York Heart Association&#xD;
             Classification.&#xD;
&#xD;
          5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase &gt; 3x upper&#xD;
             limit of normal or bilirubin &gt; 2.0 mg/dL.&#xD;
&#xD;
          6. Patients with creatinine clearance rate &lt; 50ml/min.&#xD;
&#xD;
          7. Patients with active hepatitis B or hepatitis C infection.&#xD;
&#xD;
          8. Patients with HIV infection.&#xD;
&#xD;
          9. Patients with active tuberculosis infection.&#xD;
&#xD;
         10. Patients with uncontrolled active bleeding.&#xD;
&#xD;
         11. Patients with a history of allergy to experimental drugs.&#xD;
&#xD;
         12. Patients with other commodities that the investigators considered not suitable for the&#xD;
             enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaowen Tang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Soochow University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaowen Tang, Ph.D.</last_name>
    <phone>(0086)51267781856</phone>
    <email>xwtang1020@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Depei Wu, Ph.D.</last_name>
    <phone>(0086)51267781856</phone>
    <email>drwudepei@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaowen Tang, Ph.D</last_name>
      <phone>(0086)51267781856</phone>
      <email>xwtang1020@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>T-ALL/LBL</keyword>
  <keyword>T/M-MPAL</keyword>
  <keyword>Decitabine combined with HAAG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, T-Cell</mesh_term>
    <mesh_term>Precursor T-Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Decitabine</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/NCT04446130
org study id: DAC-HAAG-03
nct id: NCT04446130
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of decitabine combined with
      HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and
      ALL/LBL with myeloid or stem cell markers.
This is a phase 3, open label, single arm, multi-center study in newly diagnosed ETP-ALL/LBL,
      T/M-MPAL and ALL/LBL patients who have myeloid or stem cell markers. The patients will
      receive decitabine combined with HAAG regimen in the induction treatment. The patients who
      respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional
      allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance
      treatment with decitabine according to patient's wishes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: Day 28-35 of induction course
description: ORR includes complete remission (CR), CR with incomplete hematologic recovery (CRi) and partial remission (PR). CR was defined as < 5% bone marrow blasts in an aspirate with spicules and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
measure: Overall survival (OS)
time frame: 4 years
description: time from randomization to death from any cause
measure: Leukemia-free survival (LFS)
time frame: 4 years
description: time from randomization to the first relapse or death
measure: Cumulative incidence of relapse(CIR)
time frame: 4 years
description: time from achievement of a remmission to the first relapse
measure: Number of adverse events
time frame: 3 years
description: adverse events are evaluated with CTCAE V5.0.
arm group label: Decitabine combined with HAAG Regimen
arm group type: Experimental
description: This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed T-ALL/LBL and T/M-MPAL patients.
intervention type: Drug
intervention name: Decitabine combined with HAAG Regimen
description: Decitabine :20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine :1mg/d,d3~16,intravenous infusion; Aclarubicin :10mg/d, d3~d10, intravenous infusion; Cytarabine :10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection
arm group label: Decitabine combined with HAAG Regimen
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xiaowen Tang, Ph.D.
role: Principal Investigator
affiliation: The First Affiliated Hospital of Soochow University
last name: Xiaowen Tang, Ph.D.
phone: (0086)51267781856
email: xwtang1020@163.com
last name: Depei Wu, Ph.D.
phone: (0086)51267781856
email: drwudepei@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, T-Cell
mesh term: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Decitabine