<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/NCT03805789</url>
  </required_header>
  <id_info>
    <org_study_id>CSL964_2001</org_study_id>
    <secondary_id>2018-000329-29</secondary_id>
    <nct_id>NCT03805789</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant</brief_title>
  <acronym>MODULAATE</acronym>
  <official_title>A Phase 2/3, Multicenter, randOmized, Double-blind, Placebo-controlled, stUdy to evaLuate the Safety and Efficacy of Alpha-1 AntiTrypsin for the prEvention of Graft Versus-host Disease in Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSL Behring</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 study is a Phase 2/3 prospective, double-blind, randomized, multi-center,&#xD;
      placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an&#xD;
      allogeneic hematopoietic cell transplant (HCT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Anticipated">March 2027</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The time to Grade II-IV acute graft versus host disease (aGVHD) or death</measure>
    <time_frame>Through 180 days after hematopoietic cell transplantation (HCT)</time_frame>
    <description>Acute graft vs host disease (aGVHD) will be assessed using the modified Keystone GVHD scoring system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with lower GI aGVHD or Grade III-IV aGVHD in any organ</measure>
    <time_frame>Through 180 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with severe infections defined by NCI-CTCAE ≥ Grade 3</measure>
    <time_frame>Through Day 60 after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with Grade II-IV aGVHD or death</measure>
    <time_frame>Through 100 days and 180 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with lower GI aGVHD</measure>
    <time_frame>Through Days 60, 100 and 180 after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with severe infections defined by NCI-CTCAE ≥ Grade 3</measure>
    <time_frame>Through 100 and 180 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of deaths (relapse and nonrelapse-related)</measure>
    <time_frame>Within 180, 365, and 730 days after HCT</time_frame>
    <description>Death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with Grade III-IV aGVHD or death</measure>
    <time_frame>Through Days 60, 100, and 180 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with moderate-to-severe chronic GVHD</measure>
    <time_frame>Within 180, 365, 545, and 730 days after HCT</time_frame>
    <description>Moderate-to-severe chronic GVHD graded according to NIH scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who have discontinued immune suppression therapies including standard- of- care GVHD prophylaxis and steroid treatment</measure>
    <time_frame>Within 180 and 365 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to neutrophil engraftment</measure>
    <time_frame>Through 365 days after HCT</time_frame>
    <description>Time to the first of 3 consecutive days of absolute neutrophil counts ≥ 500/µL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to GVHD relapse-free survival</measure>
    <time_frame>Within 365 and 730 days after HCT</time_frame>
    <description>GVHD free, relapse free, survival defined as time to any of the following events: 1) Grade II-IV acute GVHD, 2) moderate-severe chronic GVHD, 3) primary malignancy relapse or 4) death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with relapse of primary malignancies</measure>
    <time_frame>Through 180, 365, and 730 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with Grade II-IV aGVHD with an overall (complete + partial) response, complete response and partial response</measure>
    <time_frame>Approximately 4 weeks after the initiation of systemic steroids during 8-week Treatment Period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects with study drug related adverse events</measure>
    <time_frame>Up to 365 days after HCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax) of AAT</measure>
    <time_frame>Before and up to 72 after infusion of AAT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve (AUC) for AAT</measure>
    <time_frame>Before and up to 72 after infusion of AAT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) of AAT</measure>
    <time_frame>Before and up to 72 after infusion of AAT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (V) for AAT</measure>
    <time_frame>Before and up to 72 after infusion of AAT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough of AAT</measure>
    <time_frame>Before and up to 72 after infusion of AAT</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Acute-graft-versus-host Disease</condition>
  <arm_group>
    <arm_group_label>AAT (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label. Alpha-1 antitrypsin (AAT) is a lyophilized product for intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AAT (medium dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label. AAT is a lyophilized product for intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AAT (high dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open label. AAT is a lyophilized product for intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AAT (selected dose from open-label)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double-blind. AAT is a lyophilized product for intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Albumin solution administered intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Alpha-1 antitrypsin (AAT)</intervention_name>
    <description>Alpha-1 antitrypsin is a lyophilized product for intravenous administration.</description>
    <arm_group_label>AAT (high dose)</arm_group_label>
    <arm_group_label>AAT (low dose)</arm_group_label>
    <arm_group_label>AAT (medium dose)</arm_group_label>
    <arm_group_label>AAT (selected dose from open-label)</arm_group_label>
    <other_name>Alpha-1 proteinase inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Albumin solution administered intravenously</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects, ≥12 years of age (≥ 18 years of age for subjects at German&#xD;
             sites only), undergoing HCT for hematological malignancies, including leukemia,&#xD;
             lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms&#xD;
&#xD;
          -  Planned myeloablative conditioning regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior autologous or allogeneic HCT&#xD;
&#xD;
          -  T-cell depleted transplant or planned use of anti-T cell antibody therapy either ex&#xD;
             vivo or in vivo (ie, anti-thymocyte globulin [ATG], alemtuzumab) for GVHD prophylaxis&#xD;
&#xD;
          -  Planned umbilical cord blood (UCB) transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Physician</last_name>
    <role>Study Director</role>
    <affiliation>CSL Behring</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Trial Registration Coordinator</last_name>
    <phone>610-878-4000</phone>
    <email>clinicaltrials@cslbehring.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Scottsdale HH Cancer Transplant</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Cancer Center (University Hospitals UH - Seidman Cancer Center Ireland Cancer Center)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Center (TriStar BMT)</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>use central contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Texas-MD Anderson Cancer Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queenland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln, lnnere Mediz</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Use Central Contact</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 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>Alpha 1-Antitrypsin Deficiency</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Protease Inhibitors</mesh_term>
    <mesh_term>Alpha 1-Antitrypsin</mesh_term>
    <mesh_term>Protein C Inhibitor</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03805789
org study id: CSL964_2001
secondary id: 2018-000329-29
nct id: NCT03805789
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a Phase 2/3 prospective, double-blind, randomized, multi-center,
      placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an
      allogeneic hematopoietic cell transplant (HCT).
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The time to Grade II-IV acute graft versus host disease (aGVHD) or death
time frame: Through 180 days after hematopoietic cell transplantation (HCT)
description: Acute graft vs host disease (aGVHD) will be assessed using the modified Keystone GVHD scoring system.
measure: Proportion of subjects with lower GI aGVHD or Grade III-IV aGVHD in any organ
time frame: Through 180 days after HCT
measure: Proportion of subjects with severe infections defined by NCI-CTCAE ≥ Grade 3
time frame: Through Day 60 after HCT
measure: Proportion of subjects with Grade II-IV aGVHD or death
time frame: Through 100 days and 180 days after HCT
measure: Proportion of subjects with lower GI aGVHD
time frame: Through Days 60, 100 and 180 after HCT
measure: Proportion of subjects with severe infections defined by NCI-CTCAE ≥ Grade 3
time frame: Through 100 and 180 days after HCT
measure: Number of deaths (relapse and nonrelapse-related)
time frame: Within 180, 365, and 730 days after HCT
description: Death by any cause
measure: Proportion of subjects with Grade III-IV aGVHD or death
time frame: Through Days 60, 100, and 180 days after HCT
measure: Proportion of subjects with moderate-to-severe chronic GVHD
time frame: Within 180, 365, 545, and 730 days after HCT
description: Moderate-to-severe chronic GVHD graded according to NIH scale
measure: Proportion of subjects who have discontinued immune suppression therapies including standard- of- care GVHD prophylaxis and steroid treatment
time frame: Within 180 and 365 days after HCT
measure: Time to neutrophil engraftment
time frame: Through 365 days after HCT
description: Time to the first of 3 consecutive days of absolute neutrophil counts ≥ 500/µL
measure: Time to GVHD relapse-free survival
time frame: Within 365 and 730 days after HCT
description: GVHD free, relapse free, survival defined as time to any of the following events: 1) Grade II-IV acute GVHD, 2) moderate-severe chronic GVHD, 3) primary malignancy relapse or 4) death.
measure: Proportion of subjects with relapse of primary malignancies
time frame: Through 180, 365, and 730 days after HCT
measure: Proportion of subjects with Grade II-IV aGVHD with an overall (complete + partial) response, complete response and partial response
time frame: Approximately 4 weeks after the initiation of systemic steroids during 8-week Treatment Period
measure: Percent of subjects with study drug related adverse events
time frame: Up to 365 days after HCT
measure: Maximum concentration (Cmax) of AAT
time frame: Before and up to 72 after infusion of AAT
measure: Area under the concentration curve (AUC) for AAT
time frame: Before and up to 72 after infusion of AAT
measure: Clearance (CL) of AAT
time frame: Before and up to 72 after infusion of AAT
measure: Volume of distribution (V) for AAT
time frame: Before and up to 72 after infusion of AAT
measure: Ctrough of AAT
time frame: Before and up to 72 after infusion of AAT
arm group label: AAT (low dose)
arm group type: Experimental
description: Open label. Alpha-1 antitrypsin (AAT) is a lyophilized product for intravenous administration
arm group label: AAT (medium dose)
arm group type: Experimental
description: Open label. AAT is a lyophilized product for intravenous administration
arm group label: AAT (high dose)
arm group type: Experimental
description: Open label. AAT is a lyophilized product for intravenous administration
arm group label: AAT (selected dose from open-label)
arm group type: Experimental
description: Double-blind. AAT is a lyophilized product for intravenous administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Albumin solution administered intravenously
intervention type: Biological
intervention name: Alpha-1 antitrypsin (AAT)
description: Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
arm group label: AAT (high dose)
arm group label: AAT (low dose)
arm group label: AAT (medium dose)
arm group label: AAT (selected dose from open-label)
other name: Alpha-1 proteinase inhibitor
intervention type: Biological
intervention name: Placebo
description: Albumin solution administered intravenously
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Study Physician
role: Study Director
affiliation: CSL Behring
last name: Trial Registration Coordinator
phone: 610-878-4000
email: clinicaltrials@cslbehring.com
facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Australia
country: Germany
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Alpha 1-Antitrypsin Deficiency
mesh term: Graft vs Host Disease
mesh term: Protease Inhibitors
mesh term: Alpha 1-Antitrypsin
mesh term: Protein C Inhibitor
sharing ipd: No