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/NCT06024031</url>
    </required_header>
    <id_info>
      <org_study_id>NAC for hematopoietic recovery</org_study_id>
      <nct_id>NCT06024031</nct_id>
    </id_info>
    <brief_title>NAC for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy</brief_title>
    <official_title>N-acetyl-L-cysteine for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy--a Prospective Single-arm Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University People's 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>
        This is a prospective single-arm clinical study to evaluate the role of NAC after&#xD;
        chemotherapy among patients with AML can promote hematopoietic recovery and does not affect&#xD;
        the remission rate of the leukemia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hematopoietic recovery after chemotherapy is an important factor affecting the prognosis of&#xD;
        acute myeloid leukemia. A previous clinical prospective cohort study showed that NAC could&#xD;
        improve the function of bone marrow endothelial progenitor cells after chemotherapy, without&#xD;
        affecting leukemia cells. Previous animal models have found that chemotherapy can reverse the&#xD;
        function of bone marrow endothelial cells in classic AML mice. NAC promotes hematopoietic&#xD;
        recovery in AML mice by improving the bone marrow endothelial cells reversed by chemotherapy.&#xD;
        Therefore, we hypothesized that the prophylactic administration of NAC after chemotherapy&#xD;
        could facilitate the recovery of hematopoietic capacity by improving the bone marrow&#xD;
        microenvironment of patients with AML.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>
      <intervention_model_description>From the first day after the end of chemotherapy: NAC 400mg tid D1-D28 was added on the basis of routine supportive therapy (blood transfusion)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to hematopoietic recovery post chemotherapy</measure>
      <time_frame>Participants will be followed for 2 months post induction chemotherapy</time_frame>
      <description>Time to hematopoietic recovery (white blood cell &gt; 1×10^9/L, platelet &gt; 20 ×10^9/L), the dosages of G-CSF, red blood cell transfusion,platelet transfusion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>complete remission rate</measure>
      <time_frame>Participants will be followed for 1 year post induction chemotherapy</time_frame>
      <description>Number of participants with complete remission will be calculated at 1-month post induction chemotherapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>relapse-free survival</measure>
      <time_frame>Participants will be followed for 1 year post induction chemotherapy</time_frame>
      <description>Number of participants with morphologic relapse will be calculated at one year post Number of participants with morphologic relapse will be calculated at one year post-HSCT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall survival</measure>
      <time_frame>Participants will be followed for 1 year post diagnosed</time_frame>
      <description>Number of participants survived for 1 year post diagnosed will be calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>Participants will be closely observed for NAC-related toxicities during the NAC administration until 1-month post induction chemotherapy.</time_frame>
      <description>Liver function, renal function, respiratory syndrom assessed by CTCAE v4.0 during oral administration of NAC.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Endothelial progenitor cells</measure>
      <time_frame>Participants will be followed for 1-month post induction chemothrapy</time_frame>
      <description>Bone marrow microenvironment was evaluated before and after chemotherapy</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Acute Myeloid Leukemia</condition>
    <arm_group>
      <arm_group_label>NAC group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low, intermediate risk AML patients were enrolled, and NAC (400mg tid) was administered orally from day1 to day 28 (D1-D28) after the end of induction chemotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>N-acetyl-L-cysteine</intervention_name>
      <description>N-acetyl-L-cysteine (Yiweishi) capsules (Guangdong Renrenkang Pharmaceutical Industry) will be given orally 400mg three times a day from day 1 to day 28 after chemotherapy. In case of drug allergy such as nausea, vomiting, rash and bronchospasm, and disease relapse, to discontinue the drug immediately.</description>
      <arm_group_label>NAC group</arm_group_label>
      <other_name>NAC (Yiweishi)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Newly diagnosed AML (except AML-M3)&#xD;
  &#xD;
            2. Low-, intermediate risk AML (according to 2022 ELN)&#xD;
  &#xD;
            3. Aged 18-60&#xD;
  &#xD;
            4. No severe organ injury 1) Creatinine &lt; 1.5mg/dl 2) Hemobilirubin ≤ 1.5 X ULN 3) AST&#xD;
               and ALT ≤ 3.0 X ULN 4) Cardiac ejection index ≥ 50%&#xD;
  &#xD;
            5. No uncontrolled active infections&#xD;
  &#xD;
            6. Sign informed consent form, have the ability to comply with study and follow-up&#xD;
               procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Hypersensitivity to NAC&#xD;
  &#xD;
            2. History of bronchial asthma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiao-Jun Huang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiao-Jun Huang, MD</last_name>
      <phone>+861088326006</phone>
      <email>xjhrm@medmail.com.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Li-Juan Hu, MD</last_name>
      <phone>+861088326006</phone>
      <email>hulijuan3619@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yuan Kong</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100032</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuan Kong, MD, PhD</last_name>
        <phone>86-10-88324670</phone>
        <email>successky@163.com</email>
      </contact>
      <investigator>
        <last_name>Xiao-Jun Huang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Li-Juan Hu, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
      <investigator_full_name>Xiao-Jun Huang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Leukemia, Myeloid</mesh_term>
      <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetylcysteine</mesh_term>
      <mesh_term>N-monoacetylcystine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06024031
  org study id: NAC for hematopoietic recovery
  nct id: NCT06024031
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective single-arm clinical study to evaluate the role of NAC after
        chemotherapy among patients with AML can promote hematopoietic recovery and does not affect
        the remission rate of the leukemia.
  Hematopoietic recovery after chemotherapy is an important factor affecting the prognosis of
        acute myeloid leukemia. A previous clinical prospective cohort study showed that NAC could
        improve the function of bone marrow endothelial progenitor cells after chemotherapy, without
        affecting leukemia cells. Previous animal models have found that chemotherapy can reverse the
        function of bone marrow endothelial cells in classic AML mice. NAC promotes hematopoietic
        recovery in AML mice by improving the bone marrow endothelial cells reversed by chemotherapy.
        Therefore, we hypothesized that the prophylactic administration of NAC after chemotherapy
        could facilitate the recovery of hematopoietic capacity by improving the bone marrow
        microenvironment of patients with AML.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: From the first day after the end of chemotherapy: NAC 400mg tid D1-D28 was added on the basis of routine supportive therapy (blood transfusion)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time to hematopoietic recovery post chemotherapy
  time frame: Participants will be followed for 2 months post induction chemotherapy
  description: Time to hematopoietic recovery (white blood cell > 1×10^9/L, platelet > 20 ×10^9/L), the dosages of G-CSF, red blood cell transfusion,platelet transfusion.
  measure: complete remission rate
  time frame: Participants will be followed for 1 year post induction chemotherapy
  description: Number of participants with complete remission will be calculated at 1-month post induction chemotherapy
  measure: relapse-free survival
  time frame: Participants will be followed for 1 year post induction chemotherapy
  description: Number of participants with morphologic relapse will be calculated at one year post Number of participants with morphologic relapse will be calculated at one year post-HSCT
  measure: overall survival
  time frame: Participants will be followed for 1 year post diagnosed
  description: Number of participants survived for 1 year post diagnosed will be calculated.
  measure: Adverse reactions
  time frame: Participants will be closely observed for NAC-related toxicities during the NAC administration until 1-month post induction chemotherapy.
  description: Liver function, renal function, respiratory syndrom assessed by CTCAE v4.0 during oral administration of NAC.
  measure: Endothelial progenitor cells
  time frame: Participants will be followed for 1-month post induction chemothrapy
  description: Bone marrow microenvironment was evaluated before and after chemotherapy
  arm group label: NAC group
  arm group type: Experimental
  description: Low, intermediate risk AML patients were enrolled, and NAC (400mg tid) was administered orally from day1 to day 28 (D1-D28) after the end of induction chemotherapy.
  intervention type: Drug
  intervention name: N-acetyl-L-cysteine
  description: N-acetyl-L-cysteine (Yiweishi) capsules (Guangdong Renrenkang Pharmaceutical Industry) will be given orally 400mg three times a day from day 1 to day 28 after chemotherapy. In case of drug allergy such as nausea, vomiting, rash and bronchospasm, and disease relapse, to discontinue the drug immediately.
  arm group label: NAC group
  other name: NAC (Yiweishi)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Xiao-Jun Huang, MD
  role: Principal Investigator
  affiliation: Peking University People's Hospital
  last name: Xiao-Jun Huang, MD
  phone: +861088326006
  email: xjhrm@medmail.com.cn
  last name: Li-Juan Hu, MD
  phone: +861088326006
  email: hulijuan3619@163.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University People's Hospital
  investigator full name: Xiao-Jun Huang
  investigator title: Professor
  mesh term: Leukemia
  mesh term: Leukemia, Myeloid
  mesh term: Leukemia, Myeloid, Acute
  mesh term: Acetylcysteine
  mesh term: N-monoacetylcystine
  sharing ipd: No