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/NCT06026371</url>
    </required_header>
    <id_info>
      <org_study_id>RG1123691</org_study_id>
      <secondary_id>NCI-2023-05599</secondary_id>
      <secondary_id>RG1123691</secondary_id>
      <nct_id>NCT06026371</nct_id>
    </id_info>
    <brief_title>Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation</brief_title>
    <official_title>Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fred Hutchinson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fred Hutchinson Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This randomized placebo-controlled double-blind phase II trial tests whether fecal&#xD;
        microorganism (microbiota) transplantation prevents severe acute graft versus host disease in&#xD;
        adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota&#xD;
        transplantation involves receiving processed fecal material orally after allogeneic HCT in&#xD;
        order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations&#xD;
        during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy&#xD;
        administration. Establishing a healthy gut microbiota via fecal transplantation may help&#xD;
        prevent acute graft versus host disease in patients undergoing allogeneic HCT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to&#xD;
        1 of 2 groups.&#xD;
  &#xD;
        GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days&#xD;
        starting at the time of neutrophil engraftment and discontinuation of anti-bacterial&#xD;
        antibiotics.&#xD;
  &#xD;
        GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil&#xD;
        engraftment and discontinuation of anti-bacterial antibiotics.&#xD;
  &#xD;
        After completion of study intervention, patients are followed up monthly until 180 days&#xD;
        post-allogeneic HCT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Grade III-IV acute graft versus host disease (GVHD)</measure>
      <time_frame>Up to 6 months post hematopoietic cell transplantation (HCT)</time_frame>
      <description>Based on IBMTR criteria and measured as a probability</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Grade II-IV acute GVHD</measure>
      <time_frame>Up to 6 months post HCT</time_frame>
      <description>Based on IBMTR criteria and measured as a probability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-relapse mortality</measure>
      <time_frame>Up to 6 months post HCT</time_frame>
      <description>Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clostridium difficile diarrhea</measure>
      <time_frame>Up to 6 months post HCT</time_frame>
      <description>Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Acute Graft Versus Host Disease</condition>
    <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
    <arm_group>
      <arm_group_label>Group I (fecal microbiota transplant)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive fecal microbiota capsules PO QD for 7 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II (Placebo)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients receive placebo PO QD for 7 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fecal Microbiota Transplantation Capsule</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Group I (fecal microbiota transplant)</arm_group_label>
      <other_name>Fecal Microbiota Preparation Delivery Capsule</other_name>
      <other_name>FMPCapDE</other_name>
      <other_name>FMT Capsule DE</other_name>
      <other_name>FMT Capsule Delivery</other_name>
      <other_name>FMT DE Capsule</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Group II (Placebo)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;= 18&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
            -  Able to take oral medications&#xD;
  &#xD;
            -  Planned T-replete allogeneic hematopoietic cell transplantation for any indication.&#xD;
               History of prior transplantation is allowed&#xD;
  &#xD;
            -  Planned GVHD prophylaxis using one of the following regimens:&#xD;
  &#xD;
                 -  Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate&#xD;
  &#xD;
                 -  Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil&#xD;
                    (MMF)&#xD;
  &#xD;
                 -  Sirolimus plus cyclosporine plus MMF&#xD;
  &#xD;
                 -  Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF)&#xD;
  &#xD;
            -  One of the following HCT donor types:&#xD;
  &#xD;
                 -  Human leukocyte antigen (HLA)-matched sibling donor&#xD;
  &#xD;
                 -  9/10 or 10/10 HLA-matched unrelated donor&#xD;
  &#xD;
                 -  HLA- haploidentical donor&#xD;
  &#xD;
                 -  Cord blood&#xD;
  &#xD;
            -  Willing to use at least 1 accepted method of contraception until day 180 after&#xD;
               transplant and agree to not donate eggs/sperm for 180 days after&#xD;
  &#xD;
            -  Not pregnant or breast feeding&#xD;
  &#xD;
            -  ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than&#xD;
               anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE)&#xD;
               grade 2 or lower&#xD;
  &#xD;
            -  ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules&#xD;
  &#xD;
            -  ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade III-IV acute GVHD&#xD;
  &#xD;
            -  ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibacterial antibiotics except&#xD;
               to those to prevent PCP infection as standard of care.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe food allergy in the form of anaphylaxis or attributable symptoms requiring&#xD;
               hospitalization&#xD;
  &#xD;
            -  History of chronic aspiration&#xD;
  &#xD;
            -  Receiving or planned to receive other experimental agents (including ex vivo T-cell&#xD;
               depletion) to prevent GVHD&#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>Armin Rashidi</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Armin Rashidi</last_name>
      <phone>206-667-2506</phone>
      <email>arashidi@fredhutch.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fred Hutch/University of Washington Cancer Consortium</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Armin Rashidi</last_name>
        <phone>206-667-2506</phone>
        <email>arashidi@fredhutch.org</email>
      </contact>
      <investigator>
        <last_name>Armin Rashidi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Graft vs Host Disease</mesh_term>
    </condition_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/NCT06026371
  org study id: RG1123691
  secondary id: NCI-2023-05599
  secondary id: RG1123691
  nct id: NCT06026371
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This randomized placebo-controlled double-blind phase II trial tests whether fecal
        microorganism (microbiota) transplantation prevents severe acute graft versus host disease in
        adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota
        transplantation involves receiving processed fecal material orally after allogeneic HCT in
        order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations
        during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy
        administration. Establishing a healthy gut microbiota via fecal transplantation may help
        prevent acute graft versus host disease in patients undergoing allogeneic HCT.
  OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to
        1 of 2 groups.
  
        GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days
        starting at the time of neutrophil engraftment and discontinuation of anti-bacterial
        antibiotics.
  
        GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil
        engraftment and discontinuation of anti-bacterial antibiotics.
  
        After completion of study intervention, patients are followed up monthly until 180 days
        post-allogeneic HCT.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).
  measure: Grade III-IV acute graft versus host disease (GVHD)
  time frame: Up to 6 months post hematopoietic cell transplantation (HCT)
  description: Based on IBMTR criteria and measured as a probability
  measure: Grade II-IV acute GVHD
  time frame: Up to 6 months post HCT
  description: Based on IBMTR criteria and measured as a probability
  measure: Non-relapse mortality
  time frame: Up to 6 months post HCT
  description: Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability
  measure: Clostridium difficile diarrhea
  time frame: Up to 6 months post HCT
  description: Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability
  arm group label: Group I (fecal microbiota transplant)
  arm group type: Experimental
  description: Patients receive fecal microbiota capsules PO QD for 7 days
  arm group label: Group II (Placebo)
  arm group type: Placebo Comparator
  description: Patients receive placebo PO QD for 7 days
  intervention type: Drug
  intervention name: Fecal Microbiota Transplantation Capsule
  description: Given PO
  arm group label: Group I (fecal microbiota transplant)
  other name: Fecal Microbiota Preparation Delivery Capsule
  other name: FMPCapDE
  other name: FMT Capsule DE
  other name: FMT Capsule Delivery
  other name: FMT DE Capsule
  intervention type: Drug
  intervention name: Placebo
  description: Given PO
  arm group label: Group II (Placebo)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Armin Rashidi
  role: Principal Investigator
  affiliation: Fred Hutch/University of Washington Cancer Consortium
  last name: Armin Rashidi
  phone: 206-667-2506
  email: arashidi@fredhutch.org
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Graft vs Host Disease
  sharing ipd: No