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/NCT05970185</url>
    </required_header>
    <id_info>
      <org_study_id>07</org_study_id>
      <nct_id>NCT05970185</nct_id>
    </id_info>
    <brief_title>Application of Immunomagnetic Beads Method in the Mobilization of Autologous Hematopoietic Stem Cell Transplantation</brief_title>
    <official_title>Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongnan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongnan 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>
        The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection&#xD;
        by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies&#xD;
        pre-treated with stem cell transplantation after mobilization, and the results were compared&#xD;
        simultaneously in the groups applying different mobilization protocols.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Treatment programs The mobilization protocol is.&#xD;
  &#xD;
          1. etoposide 0.1 grams per square meter qd d1-3&#xD;
  &#xD;
          2. algocytidine 0.5 grams per square meter q12h d1-3&#xD;
  &#xD;
          3. whitening injection (subcutaneous injection of polyethylene glycolized recombinant human&#xD;
             granulocyte-stimulating factor injection 6mg bid in the experimental group on the second&#xD;
             day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after&#xD;
             chemotherapy until the end of collection).&#xD;
  &#xD;
        In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells&#xD;
        in peripheral blood was monitored from the time leukocytes started to rise after the nadir by&#xD;
        immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage&#xD;
        of CD34+ was &gt;0.1% and peripheral blood leukocytes were &gt;3.5×109/L.&#xD;
  &#xD;
        Collection was stopped when the CD34+ cell count was &gt;5×106/kg, and no more than three&#xD;
        attempts were made. Collection was considered a failure when CD34+ cells collected in any of&#xD;
        the three attempts did not reach 2×106/kg.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>Early Phase 1</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Total CD34+ cell yield (106/kg)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Total CD34+ cell yield (106/kg)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Accuracy differences between immunomagnetic bead assays and flow cytometry assays</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Differences in the accuracy of immunomagnetic bead assay and flow cytometry in the detection of CD34+ cells after mobilization in lymphoma patients prepped for stem cell transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>One day before chemotherapy</time_frame>
      <description>height in meters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>One day before chemotherapy</time_frame>
      <description>Weight in kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital signs and physical examination</measure>
      <time_frame>One day before chemotherapy</time_frame>
      <description>Exclude unrelated organic disease by imaging studies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ECOG score (d1 pre-chemotherapy)</measure>
      <time_frame>One day before chemotherapy</time_frame>
      <description>The ECOG scoring standard (Eastern Cooperative Oncology Group) is an index to understand the patient's general health status and tolerance to treatment from the patient's physical strength. The patient's activity status is divided into 6 grades from 0 to 5, with higher scores indicating worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood routine</measure>
      <time_frame>Blood routine was tested daily, an average of 1 year</time_frame>
      <description>Blood routine: Blood routine was tested daily, and peripheral blood CD34+ cell percentage was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if CD34+ percentage was &gt;0.1% and peripheral blood leukocytes were &gt;3.5×109/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse event record</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Adverse event record: record any adverse events that occurred during the drug administration.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Granulocyte Colony-Stimulating Factor</condition>
    <arm_group>
      <arm_group_label>PEG-rhG-CSF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>G-CSF</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PEG-rhG-CSF</intervention_name>
      <description>Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy</description>
      <arm_group_label>PEG-rhG-CSF</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>G-CSF</intervention_name>
      <description>G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection</description>
      <arm_group_label>G-CSF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Malignant lymphoma diagnosed by histology and/or cytology; expected survival &gt; 3&#xD;
               months.&#xD;
  &#xD;
            2. Patients evaluated for disease in complete or partial remission.&#xD;
  &#xD;
            3. Normal bone marrow hematopoietic function; no significant cardiac or pulmonary&#xD;
               dysfunction.&#xD;
  &#xD;
            4. Liver function and biochemical tests need to meet the following criteria. ALT and AST&#xD;
               ≤ 1.5×ULN. TBIL≤1.5×ULN. Blood creatinine ≤ 1.5 × ULN.&#xD;
  &#xD;
            5. PS score of 0-2.&#xD;
  &#xD;
            6. Age ≥ 18.&#xD;
  &#xD;
            7. Women of childbearing potential must have had a pregnancy test (serum or urine) within&#xD;
               7 days prior to enrollment with a negative result and be willing to use an appropriate&#xD;
               method of contraception for the duration of the trial.&#xD;
  &#xD;
          Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant&#xD;
          and cooperated with the follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or lactating women.&#xD;
  &#xD;
            2. having other hematological disorders affecting the hematopoietic function of the bone&#xD;
               marrow&#xD;
  &#xD;
            3. those with acute or active infections who have received systemic anti-infective&#xD;
               therapy within 72h&#xD;
  &#xD;
            4. who are allergic to the study drug or other G-CSF products, or to biological agents&#xD;
               expressed by E. coli&#xD;
  &#xD;
            5. Those who, in the judgment of the investigator, have a serious concomitant disease&#xD;
               that jeopardizes patient safety or interferes with the patient's ability to complete&#xD;
               the study&#xD;
  &#xD;
            6. Other conditions that, in the judgment of the investigator, are not suitable for&#xD;
               inclusion in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fuling Zhou</last_name>
      <role>Study Director</role>
      <affiliation>Wuhan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fuling Zhou</last_name>
      <phone>+862767813137</phone>
      <email>zhoufuling@whu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhongnan Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430071</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongnan Hospital</investigator_affiliation>
      <investigator_full_name>Fuling Zhou</investigator_full_name>
      <investigator_title>Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital</investigator_title>
    </responsible_party>
    <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/NCT05970185
  org study id: 07
  nct id: NCT05970185
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection
        by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies
        pre-treated with stem cell transplantation after mobilization, and the results were compared
        simultaneously in the groups applying different mobilization protocols.
  Treatment programs The mobilization protocol is.
  
          1. etoposide 0.1 grams per square meter qd d1-3
  
          2. algocytidine 0.5 grams per square meter q12h d1-3
  
          3. whitening injection (subcutaneous injection of polyethylene glycolized recombinant human
             granulocyte-stimulating factor injection 6mg bid in the experimental group on the second
             day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after
             chemotherapy until the end of collection).
  
        In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells
        in peripheral blood was monitored from the time leukocytes started to rise after the nadir by
        immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage
        of CD34+ was >0.1% and peripheral blood leukocytes were >3.5×109/L.
  
        Collection was stopped when the CD34+ cell count was >5×106/kg, and no more than three
        attempts were made. Collection was considered a failure when CD34+ cells collected in any of
        the three attempts did not reach 2×106/kg.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Total CD34+ cell yield (106/kg)
  time frame: through study completion, an average of 1 year
  description: Total CD34+ cell yield (106/kg)
  measure: Accuracy differences between immunomagnetic bead assays and flow cytometry assays
  time frame: through study completion, an average of 1 year
  description: Differences in the accuracy of immunomagnetic bead assay and flow cytometry in the detection of CD34+ cells after mobilization in lymphoma patients prepped for stem cell transplantation
  measure: Height
  time frame: One day before chemotherapy
  description: height in meters
  measure: Weight
  time frame: One day before chemotherapy
  description: Weight in kg
  measure: Vital signs and physical examination
  time frame: One day before chemotherapy
  description: Exclude unrelated organic disease by imaging studies
  measure: ECOG score (d1 pre-chemotherapy)
  time frame: One day before chemotherapy
  description: The ECOG scoring standard (Eastern Cooperative Oncology Group) is an index to understand the patient's general health status and tolerance to treatment from the patient's physical strength. The patient's activity status is divided into 6 grades from 0 to 5, with higher scores indicating worse outcomes.
  measure: Blood routine
  time frame: Blood routine was tested daily, an average of 1 year
  description: Blood routine: Blood routine was tested daily, and peripheral blood CD34+ cell percentage was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if CD34+ percentage was >0.1% and peripheral blood leukocytes were >3.5×109/L.
  measure: Adverse event record
  time frame: through study completion, an average of 1 year
  description: Adverse event record: record any adverse events that occurred during the drug administration.
  arm group label: PEG-rhG-CSF
  arm group type: Experimental
  description: Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy
  arm group label: G-CSF
  arm group type: Active Comparator
  description: G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection
  intervention type: Drug
  intervention name: PEG-rhG-CSF
  description: Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy
  arm group label: PEG-rhG-CSF
  intervention type: Drug
  intervention name: G-CSF
  description: G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection
  arm group label: G-CSF
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fuling Zhou
  role: Study Director
  affiliation: Wuhan University
  last name: Fuling Zhou
  phone: +862767813137
  email: zhoufuling@whu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongnan Hospital
  investigator full name: Fuling Zhou
  investigator title: Head, Division of Hematology; Professor of Hematology; Doctoral advisor, Zhongnan Hospital
  sharing ipd: No