<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/NCT04440267</url>
  </required_header>
  <id_info>
    <org_study_id>IHBDH-IIT2020009-EC-1</org_study_id>
    <nct_id>NCT04440267</nct_id>
  </id_info>
  <brief_title>Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage</brief_title>
  <official_title>A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>wang, jianxiang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Hematology &amp; Blood Diseases Hospital, China</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 prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of&#xD;
      ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic&#xD;
      leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem&#xD;
      cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation&#xD;
      chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase&#xD;
      inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based&#xD;
      chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in&#xD;
      patients with acute leukemia of ambiguous lineage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 20, 2020</start_date>
  <completion_date type="Anticipated">December 20, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 20, 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>Overall survival (OS)</measure>
    <time_frame>up to 5 years</time_frame>
    <description>From the date of diagnosis until the date of death from any cause,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse free survival (RFS)</measure>
    <time_frame>up to 5 years</time_frame>
    <description>From the date of CR until the date of relapse or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The complete remission (CR) rate</measure>
    <time_frame>up to 2.5 years</time_frame>
    <description>Incidence of complete remission after induction chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality within 60 days</measure>
    <time_frame>up to 60 days</time_frame>
    <description>Proportion of patients died within 60 days</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Chromosomal abnormalities detected by G-banding</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fusion genes detected by polymerase chain reaction</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mutations detected by next-generation sequencing</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Minimal residual disease（MRD）</measure>
    <time_frame>1 year</time_frame>
    <description>The presence of small numbers of leukemic cells detected by the flow cytometry after remission</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Leukemia of Ambiguous Lineage</condition>
  <arm_group>
    <arm_group_label>single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vincristine</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>daunorubicin</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cyclophosphamide</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L-Asparaginase</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prednisone</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mercaptopurine</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methotrexate</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tyrosine kinase inhibitor</intervention_name>
    <description>acute lymphoblastic leukemia (ALL) -based chemotherapy</description>
    <arm_group_label>single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged above 14 years with acute leukemia of ambiguous lineage .&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.&#xD;
&#xD;
          3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of&#xD;
             normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic&#xD;
             transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5&#xD;
             x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must&#xD;
             have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition&#xD;
             (MUGA) scan).&#xD;
&#xD;
          4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or&#xD;
             corrected to within normal limits with supplements prior to the first dose of study&#xD;
             medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN&#xD;
&#xD;
          5. Patients should sign informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Impaired cardiac function:&#xD;
&#xD;
             Long QT syndrome or a known family history of long QT syndrome; clinically significant&#xD;
             resting brachycardia (&lt;50 beats per minute); ejection fraction &lt; 45 % on MUGA scan.&#xD;
             Corrected QT (QTc) interval &gt; 450 msec on baseline ECG (using the QTcF formula). If&#xD;
             QTcF interval&gt;450 msec and electrolytes are not within normal ranges, electrolytes&#xD;
             should be corrected and then the patient re-screened for QTc. Myocardial infarction&#xD;
             within 12 months prior to starting study; other clinically significant heart disease&#xD;
             (e.g. unstable angina, congestive heart failure or uncontrolled hypertension,&#xD;
             uncontrolled arrhythmias).&#xD;
&#xD;
          2. Other concurrent severe and/or uncontrolled medical conditions:&#xD;
&#xD;
             Patients with another primary malignant disease, except those that do not currently&#xD;
             require treatment; acute or chronic liver, pancreatic or severe renal disease; another&#xD;
             severe and/or life-threatening medical disease.&#xD;
&#xD;
          3. Patients who are: (a) pregnant and (b) breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianxiang Wang, Dr</last_name>
    <phone>86-22-23909120</phone>
    <email>wangjx@ihcams.ac.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>HBDH</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
    <investigator_full_name>wang, jianxiang</investigator_full_name>
    <investigator_title>Director of leukemia center</investigator_title>
  </responsible_party>
  <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, Lymphoid</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Daunorubicin</mesh_term>
    <mesh_term>Asparaginase</mesh_term>
    <mesh_term>Mercaptopurine</mesh_term>
    <mesh_term>Tyrosine Protein Kinase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04440267
org study id: IHBDH-IIT2020009-EC-1
nct id: NCT04440267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of
      ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic
      leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem
      cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation
      chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase
      inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based
      chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in
      patients with acute leukemia of ambiguous lineage.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: up to 5 years
description: From the date of diagnosis until the date of death from any cause,
measure: Relapse free survival (RFS)
time frame: up to 5 years
description: From the date of CR until the date of relapse or death
measure: The complete remission (CR) rate
time frame: up to 2.5 years
description: Incidence of complete remission after induction chemotherapy
measure: Mortality within 60 days
time frame: up to 60 days
description: Proportion of patients died within 60 days
measure: Chromosomal abnormalities detected by G-banding
time frame: Baseline
measure: Fusion genes detected by polymerase chain reaction
time frame: Baseline
measure: Mutations detected by next-generation sequencing
time frame: Baseline
measure: Minimal residual disease（MRD）
time frame: 1 year
description: The presence of small numbers of leukemic cells detected by the flow cytometry after remission
arm group label: single arm
arm group type: Experimental
description: Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors.
intervention type: Drug
intervention name: vincristine
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: daunorubicin
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: cyclophosphamide
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: L-Asparaginase
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: prednisone
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: mercaptopurine
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: methotrexate
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: dexamethasone
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
intervention type: Drug
intervention name: Tyrosine kinase inhibitor
description: acute lymphoblastic leukemia (ALL) -based chemotherapy
arm group label: single arm
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Jianxiang Wang, Dr
phone: 86-22-23909120
email: wangjx@ihcams.ac.cn
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
investigator full name: wang, jianxiang
investigator title: Director of leukemia center
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Acute Disease
mesh term: Dexamethasone
mesh term: Prednisone
mesh term: Cyclophosphamide
mesh term: Methotrexate
mesh term: Vincristine
mesh term: Daunorubicin
mesh term: Asparaginase
mesh term: Mercaptopurine
mesh term: Tyrosine Protein Kinase Inhibitors
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code