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/NCT06014775</url>
    </required_header>
    <id_info>
      <org_study_id>2023-D-ES</org_study_id>
      <nct_id>NCT06014775</nct_id>
    </id_info>
    <brief_title>Anti-CD38 Antibody Treating Evans Syndrome</brief_title>
    <acronym>2023-D-ES</acronym>
    <official_title>A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Evans Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Hematology &amp; Blood Diseases Hospital, China</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        A single-center, open-label, off-label use investigator-initiated clinical study with safety&#xD;
        run-in to explore the clinical activity and safety of Anti-CD38 Antibody in adult ES patients&#xD;
        who have not responded adequately or relapsed after first-line treatment and at least one&#xD;
        second-line therapy including immunosuppressive agents, Anti-CD20 Antibody and/or TPO-RA, or&#xD;
        those in whom no other second-line treatment options are suitable.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Evans' syndrome (ES) is defined as the concomitant or sequential association of warm&#xD;
        auto-immune haemolytic anaemia (AIHA) with immune thrombocytopenia (ITP), and less frequently&#xD;
        autoimmune neutropenia. ES is a rare situation that represents up to 7% of AIHA and around 2%&#xD;
        of ITP. Due to the rarity of the disease, the treatment of ES is mostly extrapolated from&#xD;
        what is recommended for isolated auto-immune cytopenia (AIC) and mostly relies on&#xD;
        corticosteroids, rituximab, splenectomy, and supportive therapies.Despite continuous progress&#xD;
        in the management of AIC and a gradual increase in ES survival, the mortality due to ES&#xD;
        remains higher than the ones of isolated AIC, supporting the need for an improvement in ES&#xD;
        management.&#xD;
  &#xD;
        A branch of pathogenesis for ES has been revealed that plasma cells secrete pathogenic&#xD;
        antibodies directed against platelet and red blood cell antigens. Antiplatelet specific&#xD;
        plasma cells have been detected in the spleen of patients with rituximab refractory ITP. In&#xD;
        those refractory cases, persistent autoreactive long-lived plasma cells in the bone marrow&#xD;
        could explain treatment failure.&#xD;
  &#xD;
        Anti-CD38 antibody, such as Daratumumab, has been developed to target tumoral plasma cells in&#xD;
        multiple myeloma, was recently found to be effective in antibody-mediated diseases, such as&#xD;
        autoimmune cytopenia following hematopoietic stem cell transplantation, systemic lupus and&#xD;
        also ES.&#xD;
  &#xD;
        This study will evaluate the safety and biologic activity of Anti-CD38 antibody in r/r&#xD;
        primary ES who fail to respond to at least one previous second-line therapy or those who&#xD;
        cannot chose suitable second-line therapy. The study will enroll approximately 10&#xD;
        participants. This trial will be conducted in China. All participants will be followed for at&#xD;
        least 16 weeks after the 8 weeks of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 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>Evaluation of overall efficacy response after Anti-CD38 antibody treatment within 8 weeks</measure>
      <time_frame>8 weeks</time_frame>
      <description>Overall response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease at least once within 8 weeks after the first dose.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety of Anti-CD38 antibody treatment</measure>
      <time_frame>24 weeks</time_frame>
      <description>Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD38 antibody treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of stable sustained response after Anti-CD38 antibody treatment at week 8</measure>
      <time_frame>8 weeks</time_frame>
      <description>Stable sustained response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease in 3 consecutive accessible assessments at least 7 days apart 8 weeks after the first dose.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With ES Response to Anti-CD38 antibody treatment</measure>
      <time_frame>24 weeks</time_frame>
      <description>Complete response (CR) is complete resolution in all autoimmune cytopenias (neutropenia, anemia thrombocytopenia) maintained for more than two months, combined with an ability to wean off corticosteroids and/or other immunosuppressive medication. Partial response (PR) is improvement in any cytopenias by at least one grade, lasting more than two months, without worsening any other cytopenias or stable disease with the ability to wean corticosteroids and/or immunosuppressive medications by at least 50%. No response (NR) is no change in cytopenias with treatment, and the inability to wean corticosteroids or other immunosuppressive medications. Progressive disease (PD) refers to obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of platelet count at each visit time point</measure>
      <time_frame>24 weeks</time_frame>
      <description>Platelet count at each visit time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of Hb value at each visit time point</measure>
      <time_frame>24 weeks</time_frame>
      <description>Hb value at each visit time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of hemolytic marker reticulocyte count at each visit time point</measure>
      <time_frame>24 weeks</time_frame>
      <description>hemolytic marker reticulocyte count at each visit time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of hemolytic marker LDH at each visit time point</measure>
      <time_frame>24 weeks</time_frame>
      <description>hemolytic marker LDH at each visit time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of hemolytic marker haptoglobin at each visit time point</measure>
      <time_frame>24 weeks</time_frame>
      <description>hemolytic marker haptoglobin at each visit time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurements of hemolytic marker total bilirubin at each visit time point</measure>
      <time_frame>24 weeks</time_frame>
      <description>hemolytic marker total bilirubin at each visit time point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency treatment</measure>
      <time_frame>24 weeks</time_frame>
      <description>Percentage of subjects who received emergency treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of platelet response</measure>
      <time_frame>24 weeks</time_frame>
      <description>The longest duration for which the subject sustained a platelet count ≥50×109/L and at least 2-fold from baseline at the meanwhile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Hb response</measure>
      <time_frame>24 weeks</time_frame>
      <description>The longest duration for which the subject sustained a Hb level ≥100 g/L, or a Hb level increased more than 20g/L than baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of concomitant drug</measure>
      <time_frame>8 weeks</time_frame>
      <description>Percentage of patients with reduced doses of corticosteroids and/or other concomitant immunosuppressive drugs at baseline by 8 weeks of treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale</measure>
      <time_frame>24 weeks</time_frame>
      <description>Changes of the subjects' numbers in WHO bleeding score after Anti-CD38 antibody treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of fatigue function in chronic disease treatment</measure>
      <time_frame>24 weeks</time_frame>
      <description>The scores of Functional Assessment of Fatigue in Chronic Illness Therapy (FACIT-F) before and after Anti-CD38 antibody treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health status survey</measure>
      <time_frame>24 weeks</time_frame>
      <description>The change of Health status Questionnaire (SF-36) score before and after Anti-CD38 antibody treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Evan Syndrome</condition>
    <condition>Treatment</condition>
    <arm_group>
      <arm_group_label>Intervention（Anti-CD38 antibody）</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 enrolled subjects : once a week x 8 doses</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anti-CD38 antibody Injection</intervention_name>
      <description>intravenous Anti-CD38 antibody administration&#xD;
  This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks.&#xD;
  The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment.&#xD;
  The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.</description>
      <arm_group_label>Intervention（Anti-CD38 antibody）</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female aged ≥18 years.&#xD;
  &#xD;
            -  Prior to enrollment, a clinical diagnosis of primary Evans syndrome was made.&#xD;
  &#xD;
            -  Platelet count &lt; 30×10^9/L or Hb &lt; 100g/L or symptomatic anemia within 48 hours before&#xD;
               the first administration of study drug;&#xD;
  &#xD;
            -  Failure to achieve response or relapse after corticosteroid therapy, and at least one&#xD;
               second-line therapy or those who cannot chose other second-line therapy;&#xD;
  &#xD;
            -  If receiving emergency care for ES, treatment should be stopped &gt;2 weeks before first&#xD;
               dose.&#xD;
  &#xD;
            -  DAT positive (IgG+, with or without C3+).&#xD;
  &#xD;
            -  The patient need to be in the state of active hemolysis.&#xD;
  &#xD;
            -  With normal hepatic and renal functions.&#xD;
  &#xD;
            -  ECOG performance status ≤2.&#xD;
  &#xD;
            -  Cardiac function: New York Heart Association functional class ≤2.&#xD;
  &#xD;
            -  For patients receiving maintenance treatment, corticosteroids must have a stable dose&#xD;
               at least 2 weeks before the first administration, TPO receptor agonists and&#xD;
               azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at&#xD;
               least 4 weeks before the first administration; The end of anti-CD20 antibody treatment&#xD;
               was&gt;6 months.The end of alkylating agent treatment was&gt;2 months.&#xD;
  &#xD;
            -  Understand the study procedures and voluntarily sign the informed consent form in&#xD;
               person.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Secondary Evans syndrome. Received any treatment of anti-CD38 antibody drug&#xD;
  &#xD;
            -  Uncontrollable primary diseases of important organs, such as malignant tumors, liver&#xD;
               failure, heart failure, renal failure and other diseases;&#xD;
  &#xD;
            -  HIV positive;&#xD;
  &#xD;
            -  Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C,&#xD;
               cytomegalovirus, EB virus and syphilis positive;&#xD;
  &#xD;
            -  Accompanied by extensive and severe bleeding, such as hemoptysis, upper&#xD;
               gastrointestinal hemorrhage, intracranial hemorrhage, etc.;&#xD;
  &#xD;
            -  At present, there are heart diseases, arrhythmias that need treatment or hypertension&#xD;
               that researchers judge is poorly controlled;&#xD;
  &#xD;
            -  Patients with thrombotic diseases such as pulmonary embolism, thrombosis and&#xD;
               atherosclerosis;&#xD;
  &#xD;
            -  Those who have received allogeneic stem cell transplantation or organ transplantation&#xD;
               in the past;&#xD;
  &#xD;
            -  Patients with mental disorders who cannot normally obtain informed consent and conduct&#xD;
               trials and follow-up;&#xD;
  &#xD;
            -  Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;&#xD;
  &#xD;
            -  Other serious diseases that may limit the subject's participation in this test (such&#xD;
               as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable&#xD;
               arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);&#xD;
  &#xD;
            -  Patients with septicemia or other irregular severe bleeding;&#xD;
  &#xD;
            -  Patients taking antiplatelet drugs at the same time;&#xD;
  &#xD;
            -  Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic&#xD;
               gonadotropin in urine at screening) and lactating patients.&#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>Lei Zhang, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ting Sun, M.D</last_name>
      <phone>+86 022-23909009</phone>
      <email>sunting@ihcams.ac.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese Academy of Medical Science and Blood Disease Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ting Sun, M.D</last_name>
        <phone>+86-22-23909009</phone>
        <email>sunting@ihcams.ac.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
      <investigator_full_name>Zhang Lei, MD</investigator_full_name>
      <investigator_title>vice Director of Thrombosis and Hemostasis Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anemia, Hemolytic, Autoimmune</mesh_term>
      <mesh_term>Thrombocytopenia</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.</ipd_description>
      <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_time_frame>12 months to 36 months after study completion</ipd_time_frame>
      <ipd_access_criteria>Upon request to PI</ipd_access_criteria>
    </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/NCT06014775
  org study id: 2023-D-ES
  nct id: NCT06014775
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A single-center, open-label, off-label use investigator-initiated clinical study with safety
        run-in to explore the clinical activity and safety of Anti-CD38 Antibody in adult ES patients
        who have not responded adequately or relapsed after first-line treatment and at least one
        second-line therapy including immunosuppressive agents, Anti-CD20 Antibody and/or TPO-RA, or
        those in whom no other second-line treatment options are suitable.
  Evans' syndrome (ES) is defined as the concomitant or sequential association of warm
        auto-immune haemolytic anaemia (AIHA) with immune thrombocytopenia (ITP), and less frequently
        autoimmune neutropenia. ES is a rare situation that represents up to 7% of AIHA and around 2%
        of ITP. Due to the rarity of the disease, the treatment of ES is mostly extrapolated from
        what is recommended for isolated auto-immune cytopenia (AIC) and mostly relies on
        corticosteroids, rituximab, splenectomy, and supportive therapies.Despite continuous progress
        in the management of AIC and a gradual increase in ES survival, the mortality due to ES
        remains higher than the ones of isolated AIC, supporting the need for an improvement in ES
        management.
  
        A branch of pathogenesis for ES has been revealed that plasma cells secrete pathogenic
        antibodies directed against platelet and red blood cell antigens. Antiplatelet specific
        plasma cells have been detected in the spleen of patients with rituximab refractory ITP. In
        those refractory cases, persistent autoreactive long-lived plasma cells in the bone marrow
        could explain treatment failure.
  
        Anti-CD38 antibody, such as Daratumumab, has been developed to target tumoral plasma cells in
        multiple myeloma, was recently found to be effective in antibody-mediated diseases, such as
        autoimmune cytopenia following hematopoietic stem cell transplantation, systemic lupus and
        also ES.
  
        This study will evaluate the safety and biologic activity of Anti-CD38 antibody in r/r
        primary ES who fail to respond to at least one previous second-line therapy or those who
        cannot chose suitable second-line therapy. The study will enroll approximately 10
        participants. This trial will be conducted in China. All participants will be followed for at
        least 16 weeks after the 8 weeks of treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Evaluation of overall efficacy response after Anti-CD38 antibody treatment within 8 weeks
  time frame: 8 weeks
  description: Overall response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease at least once within 8 weeks after the first dose.
  measure: Safety of Anti-CD38 antibody treatment
  time frame: 24 weeks
  description: Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD38 antibody treatment
  measure: Evaluation of stable sustained response after Anti-CD38 antibody treatment at week 8
  time frame: 8 weeks
  description: Stable sustained response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease in 3 consecutive accessible assessments at least 7 days apart 8 weeks after the first dose.
  measure: Number of Participants With ES Response to Anti-CD38 antibody treatment
  time frame: 24 weeks
  description: Complete response (CR) is complete resolution in all autoimmune cytopenias (neutropenia, anemia thrombocytopenia) maintained for more than two months, combined with an ability to wean off corticosteroids and/or other immunosuppressive medication. Partial response (PR) is improvement in any cytopenias by at least one grade, lasting more than two months, without worsening any other cytopenias or stable disease with the ability to wean corticosteroids and/or immunosuppressive medications by at least 50%. No response (NR) is no change in cytopenias with treatment, and the inability to wean corticosteroids or other immunosuppressive medications. Progressive disease (PD) refers to obtaining a CR or PR by the 3 month observation and relapsing or progressing by the 6 month observation, leading to cessation of study drug.
  measure: Measurements of platelet count at each visit time point
  time frame: 24 weeks
  description: Platelet count at each visit time point
  measure: Measurements of Hb value at each visit time point
  time frame: 24 weeks
  description: Hb value at each visit time point
  measure: Measurements of hemolytic marker reticulocyte count at each visit time point
  time frame: 24 weeks
  description: hemolytic marker reticulocyte count at each visit time point
  measure: Measurements of hemolytic marker LDH at each visit time point
  time frame: 24 weeks
  description: hemolytic marker LDH at each visit time point
  measure: Measurements of hemolytic marker haptoglobin at each visit time point
  time frame: 24 weeks
  description: hemolytic marker haptoglobin at each visit time point
  measure: Measurements of hemolytic marker total bilirubin at each visit time point
  time frame: 24 weeks
  description: hemolytic marker total bilirubin at each visit time point
  measure: Emergency treatment
  time frame: 24 weeks
  description: Percentage of subjects who received emergency treatment
  measure: Duration of platelet response
  time frame: 24 weeks
  description: The longest duration for which the subject sustained a platelet count ≥50×109/L and at least 2-fold from baseline at the meanwhile
  measure: Duration of Hb response
  time frame: 24 weeks
  description: The longest duration for which the subject sustained a Hb level ≥100 g/L, or a Hb level increased more than 20g/L than baseline
  measure: Reduction of concomitant drug
  time frame: 8 weeks
  description: Percentage of patients with reduced doses of corticosteroids and/or other concomitant immunosuppressive drugs at baseline by 8 weeks of treatment
  measure: Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale
  time frame: 24 weeks
  description: Changes of the subjects' numbers in WHO bleeding score after Anti-CD38 antibody treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
  measure: Assessment of fatigue function in chronic disease treatment
  time frame: 24 weeks
  description: The scores of Functional Assessment of Fatigue in Chronic Illness Therapy (FACIT-F) before and after Anti-CD38 antibody treatment
  measure: Health status survey
  time frame: 24 weeks
  description: The change of Health status Questionnaire (SF-36) score before and after Anti-CD38 antibody treatment
  arm group label: Intervention（Anti-CD38 antibody）
  arm group type: Experimental
  description: 10 enrolled subjects : once a week x 8 doses
  intervention type: Drug
  intervention name: Anti-CD38 antibody Injection
  description: intravenous Anti-CD38 antibody administration
  This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks.
  The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment.
  The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.
  arm group label: Intervention（Anti-CD38 antibody）
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lei Zhang, M.D
  role: Principal Investigator
  affiliation: Institute of Hematology & Blood Diseases Hospital, China
  last name: Ting Sun, M.D
  phone: +86 022-23909009
  email: sunting@ihcams.ac.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
  investigator full name: Zhang Lei, MD
  investigator title: vice Director of Thrombosis and Hemostasis Center
  mesh term: Anemia, Hemolytic, Autoimmune
  mesh term: Thrombocytopenia
  mesh term: Syndrome
  mesh term: Antibodies
  sharing ipd: Yes
  ipd description: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 12 months to 36 months after study completion
  ipd access criteria: Upon request to PI