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/NCT06020833</url>
    </required_header>
    <id_info>
      <org_study_id>Roxadustat-RA-MDS</org_study_id>
      <nct_id>NCT06020833</nct_id>
    </id_info>
    <brief_title>A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS</brief_title>
    <official_title>A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College 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>
        Roxadustat has been approved for low-risk MDS clinical trials, but the trial results are not&#xD;
        available. For refractory low-risk MDS, the effective rate of roxadustat treatment is about&#xD;
        20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment&#xD;
        of refractory low-risk MDS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with low-risk myelodysplastic syndrome who are refractory to the regular treatments&#xD;
        have to live on transfusions which lead to poor quality of life (QoL) and survival.&#xD;
        Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which increases&#xD;
        both endogenous EPO and iron metabolism, has shown promising results in several phase 3&#xD;
        clinical trials for chronic kidney disease.&#xD;
  &#xD;
        Roxadustat comprehensively improves iron metabolism by upregulating DCYTB and DMT1 through&#xD;
        the HIF pathway, which can promote the iron absorption and utilization. Detail mechanisms&#xD;
        include upregulating transferrin receptors to increase iron uptake, upregulating transferrin&#xD;
        to promote iron transport and downregulating ferritin levels to indirectly improve iron&#xD;
        absorption and transportation.&#xD;
  &#xD;
        Patients with refractory low-risk MDS were selected and given roxadustat 150mg po qod&#xD;
        combined with retinoic acid 20mg po bid.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>Phase 1/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 response rate (OR)</measure>
      <time_frame>3, 6 months</time_frame>
      <description>Complete and partial remission with roxadustat combined with retinoic acid. Partial remission includes freedom from transfusion dependence or reduction in transfusion volume within 8 weeks</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Myelodysplastic Syndromes</condition>
    <arm_group>
      <arm_group_label>Roxadustat combined with retinoic acid group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Roxadustat in combination with retinoic acid</intervention_name>
      <description>Roxadustat 150mg po qod combined with retinoic acid 20mg po bid</description>
      <arm_group_label>Roxadustat combined with retinoic acid group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Low-risk MDS unresponsive to first-line therapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  myelofibrosis&#xD;
  &#xD;
            -  Severe heart and kidney function bu'quan&#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_contact>
      <last_name>bing Han, Ph.D</last_name>
      <phone>+86 13601059938</phone>
      <email>hanbing_li@sina.com.cn</email>
    </overall_contact>
    <reference>
      <citation>Carraway HE, Saygin C. Therapy for lower-risk MDS. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):426-433. doi: 10.1182/hematology.2020000127.</citation>
      <PMID>33275714</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 17, 2022</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Bing Han</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>Myelodysplastic Syndromes</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tretinoin</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/NCT06020833
  org study id: Roxadustat-RA-MDS
  nct id: NCT06020833
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Roxadustat has been approved for low-risk MDS clinical trials, but the trial results are not
        available. For refractory low-risk MDS, the effective rate of roxadustat treatment is about
        20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment
        of refractory low-risk MDS.
  Patients with low-risk myelodysplastic syndrome who are refractory to the regular treatments
        have to live on transfusions which lead to poor quality of life (QoL) and survival.
        Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which increases
        both endogenous EPO and iron metabolism, has shown promising results in several phase 3
        clinical trials for chronic kidney disease.
  
        Roxadustat comprehensively improves iron metabolism by upregulating DCYTB and DMT1 through
        the HIF pathway, which can promote the iron absorption and utilization. Detail mechanisms
        include upregulating transferrin receptors to increase iron uptake, upregulating transferrin
        to promote iron transport and downregulating ferritin levels to indirectly improve iron
        absorption and transportation.
  
        Patients with refractory low-risk MDS were selected and given roxadustat 150mg po qod
        combined with retinoic acid 20mg po bid.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: overall response rate (OR)
  time frame: 3, 6 months
  description: Complete and partial remission with roxadustat combined with retinoic acid. Partial remission includes freedom from transfusion dependence or reduction in transfusion volume within 8 weeks
  arm group label: Roxadustat combined with retinoic acid group
  arm group type: Experimental
  intervention type: Drug
  intervention name: Roxadustat in combination with retinoic acid
  description: Roxadustat 150mg po qod combined with retinoic acid 20mg po bid
  arm group label: Roxadustat combined with retinoic acid group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: bing Han, Ph.D
  phone: +86 13601059938
  email: hanbing_li@sina.com.cn
  citation: Carraway HE, Saygin C. Therapy for lower-risk MDS. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):426-433. doi: 10.1182/hematology.2020000127.
  PMID: 33275714
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Bing Han
  investigator title: Professor
  mesh term: Myelodysplastic Syndromes
  mesh term: Tretinoin
  sharing ipd: No