<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/NCT01712308</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0534</org_study_id>
    <secondary_id>NCI-2012-03139</secondary_id>
    <secondary_id>2012-0534</secondary_id>
    <nct_id>NCT01712308</nct_id>
  </id_info>
  <brief_title>Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia</brief_title>
  <official_title>A Phase-2, Prospective, Open-Label Study to Determine the Safety and Efficacy of Sotatercept (ACE-011) in Subjects With Myeloproliferative Neoplasm (MPN) -Associated Myelofibrosis and Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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 phase II trial studies the side effects of and how well sotatercept works in treating&#xD;
      patients with myeloproliferative neoplasm-associated myelofibrosis or anemia. Sotatercept may&#xD;
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this clinical research study is to learn if sotatercept can help to control&#xD;
      MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study.&#xD;
&#xD;
      Patients receive sotatercept subcutaneously (SC) once every 3 weeks. Cycles repeat every 3&#xD;
      weeks in the absence of disease progression or unacceptable toxicity. Patients unable to&#xD;
      achieve anemia-response after 8 cycles will be taken off study.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2013</start_date>
  <completion_date type="Actual">May 24, 2022</completion_date>
  <primary_completion_date type="Actual">May 24, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anemia-response</measure>
    <time_frame>Up to 84 days</time_frame>
    <description>Defined as an increase in hemoglobin level equal to or greater than 1.5 g/L without red blood cell-transfusion OR becoming red blood cell-transfusion-independent in a patient who is red blood cell-transfusion-dependent. Will be based on the intent-to-treat principle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Up to 9 years</time_frame>
    <description>Response date to loss of response or last follow up.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Anemia</condition>
  <condition>Myelodysplastic/Myeloproliferative Neoplasm</condition>
  <condition>Myelofibrosis</condition>
  <arm_group>
    <arm_group_label>Treatment Monotherapy (sotatercept)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment combination (Ruxolitinib + sotatercept)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Sotatercept</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment Monotherapy (sotatercept)</arm_group_label>
    <arm_group_label>Treatment combination (Ruxolitinib + sotatercept)</arm_group_label>
    <other_name>ACE-011</other_name>
    <other_name>Decoy Activin Receptor ACE-011</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib</intervention_name>
    <arm_group_label>Treatment combination (Ruxolitinib + sotatercept)</arm_group_label>
    <other_name>INCB018424</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MPN-associated myelofibrosis&#xD;
&#xD;
          -  Anemic patient OR red blood cell (RBC)-transfusion-dependent patient&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and&#xD;
             aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])&#xD;
             equal to or less than 2.5 x upper limit of normal (ULN), or equal to or less than 4 x&#xD;
             ULN (if upon judgment of the treating physician, it is believed to be due to&#xD;
             extramedullary hematopoiesis [EMH] related to myelofibrosis [MF])&#xD;
&#xD;
          -  Direct bilirubin equal to or less than 1.5 x ULN; or equal to or less than 2 x ULN (if&#xD;
             upon judgment of the treating physician, it is believed to be due to extramedullary&#xD;
             hematopoiesis related to MF)&#xD;
&#xD;
          -  Creatinine clearance equal to or more than 50 mL/min&#xD;
&#xD;
          -  Treatment-related toxicities from prior therapies must have resolved to grade equal to&#xD;
             or less than 1&#xD;
&#xD;
          -  Women of childbearing potential and men must agree to using medically approved (i.e.,&#xD;
             mechanical or pharmacological) contraceptive measure for at least 112 days following&#xD;
             the last dose of sotatercept (ACE-011); males must agree to use a latex condom or&#xD;
             non-latex condom NOT made of natural (animal) membrane during any sexual contact with&#xD;
             females of childbearing potential or a pregnant female while participating in the&#xD;
             study and for at least 112 days following the last dose of sotatercept (ACE-011), even&#xD;
             if he has a vasectomy&#xD;
&#xD;
          -  For cohort of patients that are already on ruxolitinib therapy: on therapy with&#xD;
             ruxolitinib for at least for 6 months, and on stable dose for last 2 months, before&#xD;
             starting therapy with sotatercept&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious medical condition or psychiatric illness that would prevent, (as judged by the&#xD;
             treating physician) the subject from signing the informed consent form or any&#xD;
             condition including the presence of laboratory abnormalities, which places the subject&#xD;
             at unacceptable risk if he/she were to participate in the study or confounds the&#xD;
             ability to interpret data from the study&#xD;
&#xD;
          -  Pregnant or lactating female&#xD;
&#xD;
          -  Known positive for human immunodeficiency virus-1 (HIV-1), or active infection with&#xD;
             hepatitis-B or -C&#xD;
&#xD;
          -  Use of any MPN-associated myelofibrosis-directed therapy within 2 weeks prior to study&#xD;
             day 1 (other than ruxolitinib at a stable dose for patients in the combination cohort&#xD;
             as stated in inclusion criteria)&#xD;
&#xD;
          -  Symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia&#xD;
&#xD;
          -  Prior sotatercept&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to day 1&#xD;
&#xD;
          -  Severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins&#xD;
             or excipients in the investigational product&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure [SBP] equal to or more than 140 or&#xD;
             diastolic blood pressure [DBP] equal to or more than 90)&#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>Prithviraj Bose</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>May 11, 2023</results_first_submitted>
  <results_first_submitted_qc>May 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2023</results_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 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>Neoplasms</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Primary Myelofibrosis</mesh_term>
    <mesh_term>Myeloproliferative Disorders</mesh_term>
    <mesh_term>Myelodysplastic-Myeloproliferative Diseases</mesh_term>
  </condition_browse>
  <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>May 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT01712308/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Monotherapy (Sotatercept)</title>
          <description>Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC</description>
        </group>
        <group group_id="P2">
          <title>Treatment Combination (Ruxolitinib + Sotatercept)</title>
          <description>patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC&#xD;
Ruxolitinib</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Monotherapy (Sotatercept)</title>
          <description>Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC</description>
        </group>
        <group group_id="B2">
          <title>Treatment Combination (Ruxolitinib + Sotatercept)</title>
          <description>patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC&#xD;
Ruxolitinib</description>
        </group>
        <group group_id="B3">
          <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="35"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="56"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" lower_limit="47" upper_limit="83"/>
                    <measurement group_id="B2" value="71" lower_limit="47" upper_limit="84"/>
                    <measurement group_id="B3" value="67" lower_limit="47" upper_limit="84"/>
                  </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="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="35"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="43"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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="35"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anemia-response</title>
        <description>Defined as an increase in hemoglobin level equal to or greater than 1.5 g/L without red blood cell-transfusion OR becoming red blood cell-transfusion-independent in a patient who is red blood cell-transfusion-dependent. Will be based on the intent-to-treat principle.</description>
        <time_frame>Up to 84 days</time_frame>
        <population>Of the 35 participants on the monotherapy arm, 27 were evaluable for response. Of the 21 participants on the Combination Therapy arm, 19 were evaluable for response.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Monotherapy (Sotatercept)</title>
            <description>Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC</description>
          </group>
          <group group_id="O2">
            <title>Treatment Combination (Ruxolitinib + Sotatercept)</title>
            <description>patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC&#xD;
Ruxolitinib</description>
          </group>
        </group_list>
        <measure>
          <title>Anemia-response</title>
          <description>Defined as an increase in hemoglobin level equal to or greater than 1.5 g/L without red blood cell-transfusion OR becoming red blood cell-transfusion-independent in a patient who is red blood cell-transfusion-dependent. Will be based on the intent-to-treat principle.</description>
          <population>Of the 35 participants on the monotherapy arm, 27 were evaluable for response. Of the 21 participants on the Combination Therapy arm, 19 were evaluable for response.</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="27"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Response</title>
        <description>Response date to loss of response or last follow up.</description>
        <time_frame>Up to 9 years</time_frame>
        <population>Of the 35 participants on the monotherapy arm, 27 were evaluable for response. Of the 21 participants on the Combination Therapy arm, 19 were evaluable for response.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Monotherapy (Sotatercept)</title>
            <description>Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC</description>
          </group>
          <group group_id="O2">
            <title>Treatment Combination (Ruxolitinib + Sotatercept)</title>
            <description>patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC&#xD;
Ruxolitinib</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response</title>
          <description>Response date to loss of response or last follow up.</description>
          <population>Of the 35 participants on the monotherapy arm, 27 were evaluable for response. Of the 21 participants on the Combination Therapy arm, 19 were evaluable for response.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" lower_limit="3.9" upper_limit="68.4"/>
                    <measurement group_id="O2" value="19.9" lower_limit="3.7" upper_limit="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 9 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Monotherapy (Sotatercept)</title>
          <description>Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC</description>
        </group>
        <group group_id="E2">
          <title>Treatment Combination (Ruxolitinib + Sotatercept)</title>
          <description>patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.&#xD;
Sotatercept: Given SC&#xD;
Ruxolitinib</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="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Non cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </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="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </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="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </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="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="30" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorders</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="35"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="17" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="28" subjects_affected="9" subjects_at_risk="35"/>
                <counts group_id="E2" events="31" subjects_affected="14" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="34" subjects_affected="16" subjects_at_risk="35"/>
                <counts group_id="E2" events="22" subjects_affected="9" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Bleeding Hemorrhage</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </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="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Elevated Albumin/Creatinine Ratio</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>elevated transaminase levels</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Iron overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder</sub_title>
                <counts group_id="E1" events="16" subjects_affected="9" subjects_at_risk="35"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Peripheral neuropathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Psychiatric Disorders</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="21"/>
              </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="6" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash maculo papular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E2" events="10" subjects_affected="5" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="21"/>
              </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>Prithviraj Bose MD/Associate Professor</name_or_title>
      <organization>The University of Texas MD Anderson Cancer</organization>
      <phone>713-792-7747</phone>
      <email>PBose@mdanderson.org</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/NCT01712308
org study id: 2012-0534
secondary id: NCI-2012-03139
secondary id: 2012-0534
nct id: NCT01712308
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies the side effects of and how well sotatercept works in treating
      patients with myeloproliferative neoplasm-associated myelofibrosis or anemia. Sotatercept may
      stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
The goal of this clinical research study is to learn if sotatercept can help to control
      MPN-associated myelofibrosis and anemia. The safety of this drug will also be studied.

      OUTLINE: This is a dose-escalation study.

      Patients receive sotatercept subcutaneously (SC) once every 3 weeks. Cycles repeat every 3
      weeks in the absence of disease progression or unacceptable toxicity. Patients unable to
      achieve anemia-response after 8 cycles will be taken off study.

      After completion of study treatment, patients are followed up at 1 month.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anemia-response
time frame: Up to 84 days
description: Defined as an increase in hemoglobin level equal to or greater than 1.5 g/L without red blood cell-transfusion OR becoming red blood cell-transfusion-independent in a patient who is red blood cell-transfusion-dependent. Will be based on the intent-to-treat principle.
measure: Duration of Response
time frame: Up to 9 years
description: Response date to loss of response or last follow up.
arm group label: Treatment Monotherapy (sotatercept)
arm group type: Experimental
description: Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.
arm group label: Treatment combination (Ruxolitinib + sotatercept)
arm group type: Experimental
description: patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.
intervention type: Biological
intervention name: Sotatercept
description: Given SC
arm group label: Treatment Monotherapy (sotatercept)
arm group label: Treatment combination (Ruxolitinib + sotatercept)
other name: ACE-011
other name: Decoy Activin Receptor ACE-011
intervention type: Drug
intervention name: Ruxolitinib
arm group label: Treatment combination (Ruxolitinib + sotatercept)
other name: INCB018424
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prithviraj Bose
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Anemia
mesh term: Primary Myelofibrosis
mesh term: Myeloproliferative Disorders
mesh term: Myelodysplastic-Myeloproliferative Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 