<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/NCT02250300</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00022660</org_study_id>
    <nct_id>NCT02250300</nct_id>
  </id_info>
  <brief_title>MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation</brief_title>
  <official_title>MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mehdi Hamadani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</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 is a phase I/II study of MLN9708 for the prophylaxis of chronic&#xD;
      graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell&#xD;
      transplantation (HSCT).&#xD;
&#xD;
      During the phase I portion, patients undergoing both sibling and unrelated donor&#xD;
      transplantation will be enrolled on the same arm to determine the dose-limiting toxicity&#xD;
      (DLT) and maximum-tolerated dose (MTD).&#xD;
&#xD;
      During the phase II portion of the trial, patients will be enrolled into two separate and&#xD;
      independent cohorts: a) Matched sibling transplants and b) Unrelated donors transplants. Both&#xD;
      cohorts will be enrolled and analyzed separately.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  For potential candidates for this trial, the recommended acute GVHD prophylaxis is a&#xD;
           tacrolimus, methotrexate and atorvastatin combination. However, any acute GVHD&#xD;
           prophylaxis regimen at the discretion of treating physician (not involving in vivo or ex&#xD;
           vivo T-cell depletion, cluster of differentiation 34 (CD34) + cell selection, or&#xD;
           post-HCT cyclophosphamide) will be permitted.&#xD;
&#xD;
        -  During the phase I portion for chronic GVHD prophylaxis, four doses of MLN9708 will be&#xD;
           administered orally (to patients undergoing either matched sibling or unrelated donor&#xD;
           transplantation) on days 1, 8, 15 and 22, starting on day +60 to +74 post allogeneic&#xD;
           HCT.&#xD;
&#xD;
      If zero of three patients experienced DLT at dose level 2, then it would be considered a MTD.&#xD;
      If two or more patients experienced a DLT, dose escalation would halt and the dose level&#xD;
      would be expanded to six patients to determine the MTD. If the dose level below already has&#xD;
      six patients, enrolled, then it will be considered the MTD. If two or more patients&#xD;
      experience DLT on first dose level (i.e., dose level 1), then, patients will be enrolled on&#xD;
      dose level -1. No intrapatient dose escalation will be permitted.&#xD;
&#xD;
        -  MTD is defined at maximum dose level with fewer than two of six patients experiencing&#xD;
           DLT.&#xD;
&#xD;
        -  The phase II portion will utilize the MTD for MLN9708, determined from phase I portion&#xD;
           of the study. In phase II, patients will be enrolled in two independent cohorts of&#xD;
           matched sibling and matched unrelated donor transplants.&#xD;
&#xD;
        -  During the phase II portion, for chronic GVHD prophylaxis, four doses of MLN9708 will be&#xD;
           administered orally on days 1, 8, 15 and 22, starting on day +60 to +90 post allogeneic&#xD;
           HCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2014</start_date>
  <completion_date type="Actual">October 6, 2020</completion_date>
  <primary_completion_date type="Actual">October 6, 2020</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum-tolerated Dose of MLN9708.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Maximum-tolerated dose of ixazomib (MLN9708) will be determined from the incidence of dose limiting toxicities at each dosage. Results for both escalation phase cohorts (3.0 mg and 4.0 mg) were used to determine the maximum tolerated dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Incidence of Chronic Graft-versus-host Disease.</measure>
    <time_frame>1 year</time_frame>
    <description>The number of participants who have graft-versus-host disease. The two expansion phase cohorts (3.0 mg and 4.0 mg) were not included in this analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Experiencing Dose-limiting Toxicity of MLN9708</measure>
    <time_frame>4 weeks</time_frame>
    <description>A 3+3 design will be employed. At each dose, three patients will be initially evaluated. If no dose limiting toxicities are observed, the MLN9708 dose will be increased; if one dose limiting toxicity is observed, three additional patients will be treated at that dose. A dose at which two DLTs are observed in three or six patients are judged to be too toxic, the lower dose will be defined as the maximally tolerated dose (MTD).</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Allogeneic Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>MLN9708 Phase II matched sibling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MLN9708 Phase II matched unrelated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MLN9708 Phase I (2.3 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MLN9708 Phase I (3.0 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MLN9708 Phase I (4.0 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLN9708 (2.3 mg)</intervention_name>
    <description>2.3 mg</description>
    <arm_group_label>MLN9708 Phase I (2.3 mg)</arm_group_label>
    <other_name>Ixazomib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLN9708 (4.0 mg)</intervention_name>
    <description>4.0 mg</description>
    <arm_group_label>MLN9708 Phase I (4.0 mg)</arm_group_label>
    <arm_group_label>MLN9708 Phase II matched sibling</arm_group_label>
    <arm_group_label>MLN9708 Phase II matched unrelated</arm_group_label>
    <other_name>Ixazomib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLN9708 (3.0 mg)</intervention_name>
    <description>3.0 mg</description>
    <arm_group_label>MLN9708 Phase I (3.0 mg)</arm_group_label>
    <other_name>Ixazomib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of a hematological malignancy or bone marrow failure syndrome&#xD;
             undergoing (or status post) a peripheral blood allogeneic HCT.&#xD;
&#xD;
          2. Patients aged ≥18 are eligible.&#xD;
&#xD;
          3. All patients must have received or plan to receive an allograft from a suitable human&#xD;
             leukocyte antigens (HLA) -matched sibling or unrelated donor according to transplant&#xD;
             center's guidelines (for selection of appropriate donor).&#xD;
&#xD;
          4. Voluntary written consent must be given before patient registration and performance of&#xD;
             any study related procedure not part of standard medical care, with the understanding&#xD;
             that consent may be withdrawn by the patient at any time without prejudice to future&#xD;
             medical care.&#xD;
&#xD;
          5. Bilirubin ≤ 2 x the upper limit of normal (ULN). For patients with Gilbert's syndrome&#xD;
             or suspected mild veno-occlusive disease, bilirubin ≤ 3 x ULN is permitted.&#xD;
&#xD;
          6. Creatinine clearance of ≥ 30 mL/min calculated by Cockcroft-Gault equation.&#xD;
&#xD;
          7. Karnofsky performance status &gt; 60.&#xD;
&#xD;
          8. A negative pregnancy test will be required for all women of child bearing potential.&#xD;
             Females of child bearing potential should agree to practice 2 effective methods of&#xD;
             contraception, at the same time, from the time of signing the informed consent form&#xD;
             through 90 days after the last dose of study drug and must also adhere to the&#xD;
             guidelines of any treatment-specific pregnancy prevention program, if applicable, or&#xD;
             agree to practice true abstinence when this is in line with the preferred and usual&#xD;
             lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,&#xD;
             symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of&#xD;
             contraception.). Breast feeding is not permitted.&#xD;
&#xD;
          9. Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree&#xD;
             to one of the following: practice effective barrier contraception during the entire&#xD;
             study treatment period and through 90 days after the last dose of study drug, or must&#xD;
             also adhere to the guidelines of any treatment-specific pregnancy prevention program,&#xD;
             if applicable, or agree to practice true abstinence when this is in line with the&#xD;
             preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar,&#xD;
             ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable&#xD;
             methods of contraception.)&#xD;
&#xD;
         10. No evidence of uncontrolled bacterial, viral or fungal infections at the time of&#xD;
             enrollment.&#xD;
&#xD;
         11. No known active hepatitis B or C virus infection, or known human immunodeficiency&#xD;
             virus (HIV) positive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active ≥ grade 3 peripheral neuropathy or grade 2 with pain on clinical&#xD;
             examination during the screening period will be excluded.&#xD;
&#xD;
          2. Patients with history of allergy and/or intolerance to MLN9708 are not eligible.&#xD;
&#xD;
          3. Known GI disease or GI procedure that could interfere with the oral absorption or&#xD;
             tolerance of MLN9708 including difficulty swallowing is not permitted.&#xD;
&#xD;
          4. Patients receiving (or status post) a cord blood or a haplo-identical allograft will&#xD;
             not be eligible.&#xD;
&#xD;
          5. Patients undergoing (or status post) a T-cell depleted allogeneic transplantation will&#xD;
             not be eligible.&#xD;
&#xD;
          6. Patients receiving (or status post) conditioning regimens containing antithymocyte&#xD;
             globulin, and/or campath, one receiving post-HCT planned cyclophosphamide will not be&#xD;
             eligible.&#xD;
&#xD;
          7. Method of stem-cell collection from the donor will be at the discretion of the&#xD;
             treating physician. Although it is anticipated that majority of patients will receive&#xD;
             allograft mobilized with Granulocyte- colony stimulating factor (CSF) alone; however&#xD;
             donors receiving allografts mobilized with experimental agents (e.g. plerixafor) will&#xD;
             remain eligible for the study.&#xD;
&#xD;
          8. Patients experiencing disease relapse (for those in complete remission at the time of&#xD;
             HCT) or progression (for those in partial remission, stable or refractory disease at&#xD;
             the time of HCT) will be excluded.&#xD;
&#xD;
          9. Donor lymphocyte infusions between day zero of HCT and first dose of MLN9708 are not&#xD;
             permitted.&#xD;
&#xD;
         10. Rituximab (or other B-cell depleting monoclonal antibodies) or bortezomib&#xD;
             administration between day zero of HCT and before the first day of MLN9708 is not&#xD;
             permitted.&#xD;
&#xD;
         11. Patients with steroid refractory (defined as no improvement of symptoms after 7 days&#xD;
             of systemic corticosteroids at a dose of ≥1mg/kg/day) grade II-IV acute GVHD, that is&#xD;
             active at the time of enrollment will be excluded.&#xD;
&#xD;
         12. Patients with grade III-IV acute GVHD (even if it is not meeting criteria for steroid&#xD;
             refractory acute GVHD), that is active at the time of enrollment will be excluded.&#xD;
             Patients with controlled grade I-II acute GVHD can be enrolled after discussing with&#xD;
             study PI. Topical or systemic corticosteroids therapy, as per standard of care for&#xD;
             such grade I-II acute GVHD patients is permitted.&#xD;
&#xD;
         13. Patients with active chronic GVHD (although unlikely before day +100) will be&#xD;
             excluded.&#xD;
&#xD;
         14. No major surgery within 14 days before enrollment.&#xD;
&#xD;
         15. No radiotherapy within 14 days before enrollment. If the involved field is small, 7&#xD;
             days will be considered a sufficient interval between treatment and administration of&#xD;
             the MLN9708.&#xD;
&#xD;
         16. No evidence of current uncontrolled cardiovascular conditions, including uncontrolled&#xD;
             hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure,&#xD;
             unstable angina, or myocardial infarction within the past 6 months. Cardiac enzyme&#xD;
             elevations for reasons other than document myocardial infarction is not an exclusion.&#xD;
&#xD;
         17. No systemic treatment, within 14 days before the first dose of MLN9708, with strong&#xD;
             inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of&#xD;
             cytochrome P450, family 3, subfamily A (CYP3A) (clarithromycin, telithromycin,&#xD;
             itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A&#xD;
             inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital),&#xD;
             or use of Ginkgo biloba or St. John's wort.&#xD;
&#xD;
         18. No serious medical or psychiatric illness that could, in the investigator's opinion,&#xD;
             potentially interfere with the completion of treatment according to this protocol.&#xD;
&#xD;
         19. No participation in other clinical trials, including those with other investigational&#xD;
             agents within 21days of the start of this trial and throughout the duration of this&#xD;
             trial. However co-enrollment on trials evaluating conditioning regimens, institutional&#xD;
             protocols evaluating atorvastatin for acute GVHD prophylaxis, and stem cell collection&#xD;
             protocols in transplant donors will be permitted. In addition patients randomized to&#xD;
             standard-of-care (non experimental) arms of available phase II/III trials will be&#xD;
             eligible for 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>Mehdi Hamadani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Froedtert Hospital and the Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Chhabra S, Visotcky A, Pasquini MC, Zhu F, Tang X, Zhang MJ, Thompson R, Abedin S, D'Souza A, Dhakal B, Drobyski WR, Fenske TS, Jerkins JH, Douglas Rizzo J, Runaas L, Saber W, Shah NN, Shaw BE, Horowitz MM, Hari PN, Hamadani M. Ixazomib for Chronic Graft-versus-Host Disease Prophylaxis following Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2020 Oct;26(10):1876-1885. doi: 10.1016/j.bbmt.2020.07.005. Epub 2020 Jul 9. Erratum In: Transplant Cell Ther. 2022 Oct;28(10):717.</citation>
    <PMID>32653622</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>January 4, 2023</results_first_submitted>
  <results_first_submitted_qc>February 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2023</results_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Mehdi Hamadani</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Stem cell transplantation</keyword>
  <keyword>Hematopoietic transplantation</keyword>
  <keyword>Hematopoietic stem cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis Obliterans Syndrome</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>Ixazomib</mesh_term>
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02250300/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02250300/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Eleven of the 68 subjects consenting to participate were determined to be ineligible to participate in the study. The remaining 57 total subjects are detailed below. The initial dose of MLN9708 in the escalation phase was 3.0mg. Due to no DLTs experienced in this group, no subjects were enrolled to the lower 2.3mg cohort.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MLN9708 Phase II Matched Sibling</title>
          <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
        </group>
        <group group_id="P2">
          <title>MLN9708 Phase II Matched Unrelated</title>
          <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
        </group>
        <group group_id="P3">
          <title>MLN9708 Phase I (3.0 mg)</title>
          <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (3.0 mg)</description>
        </group>
        <group group_id="P4">
          <title>MLN9708 Phase I (4.0 mg)</title>
          <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (4.0 mg)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Dose Escalation 3.0 mg Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Dose Escalation 4.0 mg Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0">This cohort was involved only in the 3.0 mg dose escalation phase and were not involved in subsequent phases of the study.</participants>
                <participants group_id="P4" count="3">This cohort was involved only in the 4.0 mg dose escalation phase and were not involved in prior or subsequent phases of the study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Expansion Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25">This expansion cohort involved a new group of subjects using the 4.0 mg dose.</participants>
                <participants group_id="P2" count="26">This expansion cohort involved a new group of subjects using the 4.0 mg dose.</participants>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0">This cohort was involved only in the 4.0 mg dose escalation phase and was not involved in expansion phase of the study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MLN9708 Phase II Matched Sibling</title>
          <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic hematopoietic cell transplant (HCT).&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
        </group>
        <group group_id="B2">
          <title>MLN9708 Phase II Matched Unrelated</title>
          <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
        </group>
        <group group_id="B3">
          <title>MLN9708 Phase I (3.0 mg)</title>
          <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (3.0 mg)</description>
        </group>
        <group group_id="B4">
          <title>MLN9708 Phase I (4.0 mg)</title>
          <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (4.0 mg)</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.3" spread="11.3"/>
                    <measurement group_id="B2" value="53.5" spread="12.9"/>
                    <measurement group_id="B3" value="65.3" spread="0.9"/>
                    <measurement group_id="B4" value="65.0" spread="8.0"/>
                    <measurement group_id="B5" value="53.9" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum-tolerated Dose of MLN9708.</title>
        <description>Maximum-tolerated dose of ixazomib (MLN9708) will be determined from the incidence of dose limiting toxicities at each dosage. Results for both escalation phase cohorts (3.0 mg and 4.0 mg) were used to determine the maximum tolerated dose.</description>
        <time_frame>4 weeks</time_frame>
        <population>Only the subjects in the Phase I dose escalation study are included in this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Maximum Tolerated Dose of Study Drug</title>
            <description>This measure is the maximum dosage of study drug based on the count of Drug Limiting Toxicities (DLT). The number of DLT for each dosage are listed in the results of Outcome Measure #3.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum-tolerated Dose of MLN9708.</title>
          <description>Maximum-tolerated dose of ixazomib (MLN9708) will be determined from the incidence of dose limiting toxicities at each dosage. Results for both escalation phase cohorts (3.0 mg and 4.0 mg) were used to determine the maximum tolerated dose.</description>
          <population>Only the subjects in the Phase I dose escalation study are included in this outcome measure.</population>
          <units>millligram</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cumulative Incidence of Chronic Graft-versus-host Disease.</title>
        <description>The number of participants who have graft-versus-host disease. The two expansion phase cohorts (3.0 mg and 4.0 mg) were not included in this analysis.</description>
        <time_frame>1 year</time_frame>
        <population>The Phase 1 dose escalation cohort is not included in this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>MLN9708 Phase II Matched Sibling</title>
            <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
          </group>
          <group group_id="O2">
            <title>MLN9708 Phase II Matched Unrelated</title>
            <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Incidence of Chronic Graft-versus-host Disease.</title>
          <description>The number of participants who have graft-versus-host disease. The two expansion phase cohorts (3.0 mg and 4.0 mg) were not included in this analysis.</description>
          <population>The Phase 1 dose escalation cohort is not included in this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing Dose-limiting Toxicity of MLN9708</title>
        <description>A 3+3 design will be employed. At each dose, three patients will be initially evaluated. If no dose limiting toxicities are observed, the MLN9708 dose will be increased; if one dose limiting toxicity is observed, three additional patients will be treated at that dose. A dose at which two DLTs are observed in three or six patients are judged to be too toxic, the lower dose will be defined as the maximally tolerated dose (MTD).</description>
        <time_frame>4 weeks</time_frame>
        <population>Based on the escalation schema and lack of dose limiting toxicities, the 2.3mg dosage cohort was not required.</population>
        <group_list>
          <group group_id="O1">
            <title>MLN9708 Phase I (3.0 mg)</title>
            <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (3.0 mg)</description>
          </group>
          <group group_id="O2">
            <title>MLN9708 Phase I (4.0 mg)</title>
            <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (4.0 mg)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Dose-limiting Toxicity of MLN9708</title>
          <description>A 3+3 design will be employed. At each dose, three patients will be initially evaluated. If no dose limiting toxicities are observed, the MLN9708 dose will be increased; if one dose limiting toxicity is observed, three additional patients will be treated at that dose. A dose at which two DLTs are observed in three or six patients are judged to be too toxic, the lower dose will be defined as the maximally tolerated dose (MTD).</description>
          <population>Based on the escalation schema and lack of dose limiting toxicities, the 2.3mg dosage cohort was not required.</population>
          <units>dose limiting toxicity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year.</time_frame>
      <desc>One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.</desc>
      <group_list>
        <group group_id="E1">
          <title>MLN9708 Phase II Matched Sibling</title>
          <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
        </group>
        <group group_id="E2">
          <title>MLN9708 Phase II Matched Unrelated</title>
          <description>Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 starting on day +60 to +90 post allogeneic HCT.&#xD;
MLN9708 (4.0 mg): 4.0 mg</description>
        </group>
        <group group_id="E3">
          <title>MLN9708 Phase I (3.0mg)</title>
          <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (3.0 mg)</description>
        </group>
        <group group_id="E4">
          <title>MLN9708 Phase I (4.0mg)</title>
          <description>Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, &amp; 22 orally based on a dose escalation schema.&#xD;
MLN9708 (4.0 mg)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE 4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hemolytic uremic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorders - Other, specify</sub_title>
                <description>Chemotherapy induced cardiomyopathy with left ventricular systolic dysfunction</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other, specify</sub_title>
                <description>Vancomycin resistant enterococcus</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE 4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="25"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Muscle pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter-related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mehdi Hamadani, MD</name_or_title>
      <organization>Froedtert and the Medical college of Wisconsin</organization>
      <phone>414-805-4600</phone>
      <email>mhamadani@mcw.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02250300
org study id: PRO00022660
nct id: NCT02250300
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a phase I/II study of MLN9708 for the prophylaxis of chronic
      graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell
      transplantation (HSCT).

      During the phase I portion, patients undergoing both sibling and unrelated donor
      transplantation will be enrolled on the same arm to determine the dose-limiting toxicity
      (DLT) and maximum-tolerated dose (MTD).

      During the phase II portion of the trial, patients will be enrolled into two separate and
      independent cohorts: a) Matched sibling transplants and b) Unrelated donors transplants. Both
      cohorts will be enrolled and analyzed separately.
-  For potential candidates for this trial, the recommended acute GVHD prophylaxis is a
           tacrolimus, methotrexate and atorvastatin combination. However, any acute GVHD
           prophylaxis regimen at the discretion of treating physician (not involving in vivo or ex
           vivo T-cell depletion, cluster of differentiation 34 (CD34) + cell selection, or
           post-HCT cyclophosphamide) will be permitted.

        -  During the phase I portion for chronic GVHD prophylaxis, four doses of MLN9708 will be
           administered orally (to patients undergoing either matched sibling or unrelated donor
           transplantation) on days 1, 8, 15 and 22, starting on day +60 to +74 post allogeneic
           HCT.

      If zero of three patients experienced DLT at dose level 2, then it would be considered a MTD.
      If two or more patients experienced a DLT, dose escalation would halt and the dose level
      would be expanded to six patients to determine the MTD. If the dose level below already has
      six patients, enrolled, then it will be considered the MTD. If two or more patients
      experience DLT on first dose level (i.e., dose level 1), then, patients will be enrolled on
      dose level -1. No intrapatient dose escalation will be permitted.

        -  MTD is defined at maximum dose level with fewer than two of six patients experiencing
           DLT.

        -  The phase II portion will utilize the MTD for MLN9708, determined from phase I portion
           of the study. In phase II, patients will be enrolled in two independent cohorts of
           matched sibling and matched unrelated donor transplants.

        -  During the phase II portion, for chronic GVHD prophylaxis, four doses of MLN9708 will be
           administered orally on days 1, 8, 15 and 22, starting on day +60 to +90 post allogeneic
           HCT.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum-tolerated Dose of MLN9708.
time frame: 4 weeks
description: Maximum-tolerated dose of ixazomib (MLN9708) will be determined from the incidence of dose limiting toxicities at each dosage. Results for both escalation phase cohorts (3.0 mg and 4.0 mg) were used to determine the maximum tolerated dose.
measure: Cumulative Incidence of Chronic Graft-versus-host Disease.
time frame: 1 year
description: The number of participants who have graft-versus-host disease. The two expansion phase cohorts (3.0 mg and 4.0 mg) were not included in this analysis.
measure: Number of Participants Experiencing Dose-limiting Toxicity of MLN9708
time frame: 4 weeks
description: A 3+3 design will be employed. At each dose, three patients will be initially evaluated. If no dose limiting toxicities are observed, the MLN9708 dose will be increased; if one dose limiting toxicity is observed, three additional patients will be treated at that dose. A dose at which two DLTs are observed in three or six patients are judged to be too toxic, the lower dose will be defined as the maximally tolerated dose (MTD).
arm group label: MLN9708 Phase II matched sibling
arm group type: Experimental
description: Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, & 22 starting on day +60 to +90 post allogeneic HCT.
arm group label: MLN9708 Phase II matched unrelated
arm group type: Experimental
description: Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, & 22 starting on day +60 to +90 post allogeneic HCT.
arm group label: MLN9708 Phase I (2.3 mg)
arm group type: Experimental
description: Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, & 22 orally based on a dose escalation schema.
arm group label: MLN9708 Phase I (3.0 mg)
arm group type: Experimental
description: Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, & 22 orally based on a dose escalation schema.
arm group label: MLN9708 Phase I (4.0 mg)
arm group type: Experimental
description: Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, & 22 orally based on a dose escalation schema.
intervention type: Drug
intervention name: MLN9708 (2.3 mg)
description: 2.3 mg
arm group label: MLN9708 Phase I (2.3 mg)
other name: Ixazomib
intervention type: Drug
intervention name: MLN9708 (4.0 mg)
description: 4.0 mg
arm group label: MLN9708 Phase I (4.0 mg)
arm group label: MLN9708 Phase II matched sibling
arm group label: MLN9708 Phase II matched unrelated
other name: Ixazomib
intervention type: Drug
intervention name: MLN9708 (3.0 mg)
description: 3.0 mg
arm group label: MLN9708 Phase I (3.0 mg)
other name: Ixazomib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mehdi Hamadani, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
citation: Chhabra S, Visotcky A, Pasquini MC, Zhu F, Tang X, Zhang MJ, Thompson R, Abedin S, D'Souza A, Dhakal B, Drobyski WR, Fenske TS, Jerkins JH, Douglas Rizzo J, Runaas L, Saber W, Shah NN, Shaw BE, Horowitz MM, Hari PN, Hamadani M. Ixazomib for Chronic Graft-versus-Host Disease Prophylaxis following Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2020 Oct;26(10):1876-1885. doi: 10.1016/j.bbmt.2020.07.005. Epub 2020 Jul 9. Erratum In: Transplant Cell Ther. 2022 Oct;28(10):717.
PMID: 32653622
responsible party type: Sponsor-Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Mehdi Hamadani
investigator title: Associate Professor
mesh term: Bronchiolitis Obliterans Syndrome
mesh term: Graft vs Host Disease
mesh term: Ixazomib
mesh term: Glycine
sharing ipd: No
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