<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/NCT03041636</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0570</org_study_id>
    <secondary_id>NCI-2017-00478</secondary_id>
    <secondary_id>2015-0570</secondary_id>
    <nct_id>NCT03041636</nct_id>
  </id_info>
  <brief_title>Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</brief_title>
  <official_title>Administration of Jakafi (Ruxolitinib) to Patients With Previously Untreated High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): A Phase II Clinical Trial</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 how well ruxolitinib phosphate works in treating patients with&#xD;
      previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. Ruxolitinib&#xD;
      phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell&#xD;
      growth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effect of ruxolitinib phosphate (ruxolitinib) in patients with high-risk&#xD;
      chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who do not require&#xD;
      anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic&#xD;
      Leukemia (IWCLL) 2008 recommendations and were either previously untreated or treated with&#xD;
      Ibrutinib for less than 3 months and were deemed Ibrutinib intolerant:&#xD;
&#xD;
      Ia. On disease burden. Ib. The rate of complete response (CR) and partial response (PR) as&#xD;
      assessed by the IWCLL 2008 response criteria.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the time to next treatment of high-risk CLL/SLL who do not require&#xD;
      anti-neoplastic therapy according to the IWCLL 2008 recommendations.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive ruxolitinib phosphate orally (PO) twice daily (BID). Treatment continues for&#xD;
      up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment&#xD;
      beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2017</start_date>
  <completion_date type="Actual">April 29, 2020</completion_date>
  <primary_completion_date type="Actual">April 29, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants With a Clinical Response</measure>
    <time_frame>Up to 6 months after initiation of therapy</time_frame>
    <description>Clinical response will be assessed based on physical examination, complete blood count (CBC), a bone marrow aspiration, a whole body CT scan to be done at screening and 6 + 2 months in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines (Hallek et al., 2008)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Change of Tumor Burden</measure>
    <time_frame>6 months after initiation of therapy</time_frame>
    <description>Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants With a Response</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Response Rate is Complete Response (CR) or Partial Response (PR). CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes &lt; 4000/ul, normocellular, &lt;30% lymphocytes, no B-lymphoid nodules, Platelets &gt; 100,000/ul, hemoglobin &gt;11.0 g/dl and Neutrophils &gt;1500/ul.&#xD;
PR is &gt;/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count &gt; 100,000/ul, Hemoglobin &gt; 11 g/dl and Neutrophils &gt;1500/ul or increase &gt;/= 50% of all over base.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Next Treatment</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Number of months to subsequent therapy per patient.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</condition>
  <condition>Untreated Chronic Lymphocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>Treatment (ruxolitinib phosphate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (ruxolitinib phosphate)</arm_group_label>
    <other_name>INCB-18424</other_name>
    <other_name>INCB18424</other_name>
    <other_name>Oral JAK Inhibitor INCB18424</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib Phosphate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (ruxolitinib phosphate)</arm_group_label>
    <other_name>INCB-18424 Phosphate</other_name>
    <other_name>Jakafi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. Subjects who are able to understand and sign an informed consent document.&#xD;
&#xD;
          2. Subjects 18 years of age or older.&#xD;
&#xD;
          3. Subjects must be diagnosed with CLL/SLL and do not meet the IWCLL criteria for&#xD;
             treatment&#xD;
&#xD;
          4. Patients should be previously untreated or have only been treated with single agent&#xD;
             ibrutinib therapy for a period of &lt; 3 months and were deemed ibrutinib intolerant.&#xD;
&#xD;
          5. Patients whose expected time to CLL/SLL treatment, according to our nomogram posted on&#xD;
             the leukemia protocol priority list, is four years of less.&#xD;
&#xD;
          6. Subjects with hemoglobin values at the screening visit equal to or greater than 12.0&#xD;
             g/dL.&#xD;
&#xD;
          7. Subjects with a platelet count of at least 100 x10^9 at the screening visit.&#xD;
&#xD;
          8. Subjects with an absolute neutrophil count (ANC) of equal to or higher than 0.5 x10^9&#xD;
             at the screening visit.&#xD;
&#xD;
          9. Subject who are willing to undergo a bone marrow aspiration and biopsy and CT scan for&#xD;
             disease burden assessment.&#xD;
&#xD;
         10. Patient who are capable to return to MD Anderson Cancer Center (MDACC) for follow-up&#xD;
&#xD;
         11. Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1&#xD;
             or 2&#xD;
&#xD;
         12. Patient must be capable of swallowing the Ruxolotinib capsules (tablets).&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Females who are pregnant or are currently breastfeeding.&#xD;
&#xD;
          2. Subjects of childbearing potential who are unwilling to take appropriate precautions&#xD;
             (throughout the study from screening including 30 days after discontinuation of the&#xD;
             study drug) to avoid becoming pregnant or fathering a child. A) Females of&#xD;
             non-childbearing potential are defined as women who (a) are equal to or greater than&#xD;
             55 years of age with history of amenorrhea for 1 year, OR (b) are surgically sterile&#xD;
             for at least 3 months. B) For females of childbearing potential, or for males,&#xD;
             appropriate precautions are those that are at least 99% effective in preventing the&#xD;
             occurrence of pregnancy. These methods should be communicated to the subjects and&#xD;
             their understanding confirmed: a) Double barrier methods; b) Condom with spermicide in&#xD;
             conjunction with use of an intrauterine device (IUD); c) Condom with spermicide in&#xD;
             conjunction with use of a diaphragm; d) Oral, injectable, or implanted contraceptives;&#xD;
             e) Tubal ligation or vasectomy (surgical sterilization)&#xD;
&#xD;
          3. Subjects with recent history of inadequate bone marrow reserve as demonstrated by&#xD;
             previous transfusions except for acute blood loss (e.g. surgery) in the month prior to&#xD;
             screening.&#xD;
&#xD;
          4. Subjects with inadequate liver or renal function at screening and baseline visits: A)&#xD;
             Alanine aminotransferase (ALT) &gt; 2.5x Upper limit of normal (ULN). B) Modification of&#xD;
             Diet in Renal Disease (MDRD) calculated GFR &lt; 30 mL/min&#xD;
&#xD;
          5. Subjects with active uncontrolled infection or who are HIV positive (Subjects with&#xD;
             acute infections requiring treatment should delay screening/enrollment until the&#xD;
             course of therapy has been completed and the event is considered controlled).&#xD;
&#xD;
          6. Subjects with a history of or a current malignancy except for treated basal or&#xD;
             squamous carcinomas of the skin completely resected.&#xD;
&#xD;
          7. Subjects with clinically significant uncontrolled cardiac disease.&#xD;
&#xD;
          8. Subjects being treated concurrently with any prohibited medications, including&#xD;
             investigational medication, rifampin, St. John's wort, and potent CYP3A4 inhibitors&#xD;
             (excluding ketoconazole) unless continuation of such medications are determined by the&#xD;
             investigator to be in the best interest of the patient. Refer to protocol section&#xD;
             2.2.12 for more details.&#xD;
&#xD;
          9. Subjects who have previously received JAK inhibitor therapy&#xD;
&#xD;
         10. Subjects with active alcohol or drug addiction that would interfere with their ability&#xD;
             to comply with the study requirements.&#xD;
&#xD;
         11. Subjects with any concurrent condition that, in the Investigator's opinion, would&#xD;
             jeopardize the safety of the subject or compliance with the protocol.&#xD;
&#xD;
         12. Subjects who have unknown transfusion history.&#xD;
&#xD;
         13. Patients who cannot comply with the study requirements.&#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>Zeev Estrov</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>March 2021</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>March 23, 2021</results_first_submitted>
  <results_first_submitted_qc>March 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2021</results_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</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>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Janus Kinase Inhibitors</mesh_term>
  </intervention_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>March 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03041636/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period: March 2017 to June 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Ruxolitinib Phosphate)</title>
          <description>Patients receive ruxolitinib phosphate PO twice a daily (BID). Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Ruxolitinib Phosphate)</title>
          <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participants With a Clinical Response</title>
        <description>Clinical response will be assessed based on physical examination, complete blood count (CBC), a bone marrow aspiration, a whole body CT scan to be done at screening and 6 + 2 months in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines (Hallek et al., 2008)</description>
        <time_frame>Up to 6 months after initiation of therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ruxolitinib Phosphate)</title>
            <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With a Clinical Response</title>
          <description>Clinical response will be assessed based on physical examination, complete blood count (CBC), a bone marrow aspiration, a whole body CT scan to be done at screening and 6 + 2 months in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines (Hallek et al., 2008)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Change of Tumor Burden</title>
        <description>Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.</description>
        <time_frame>6 months after initiation of therapy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ruxolitinib Phosphate)</title>
            <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Change of Tumor Burden</title>
          <description>Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Participants With a Response</title>
        <description>Response Rate is Complete Response (CR) or Partial Response (PR). CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes &lt; 4000/ul, normocellular, &lt;30% lymphocytes, no B-lymphoid nodules, Platelets &gt; 100,000/ul, hemoglobin &gt;11.0 g/dl and Neutrophils &gt;1500/ul.&#xD;
PR is &gt;/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count &gt; 100,000/ul, Hemoglobin &gt; 11 g/dl and Neutrophils &gt;1500/ul or increase &gt;/= 50% of all over base.</description>
        <time_frame>Up to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ruxolitinib Phosphate)</title>
            <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With a Response</title>
          <description>Response Rate is Complete Response (CR) or Partial Response (PR). CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes &lt; 4000/ul, normocellular, &lt;30% lymphocytes, no B-lymphoid nodules, Platelets &gt; 100,000/ul, hemoglobin &gt;11.0 g/dl and Neutrophils &gt;1500/ul.&#xD;
PR is &gt;/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count &gt; 100,000/ul, Hemoglobin &gt; 11 g/dl and Neutrophils &gt;1500/ul or increase &gt;/= 50% of all over base.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Next Treatment</title>
        <description>Number of months to subsequent therapy per patient.</description>
        <time_frame>Up to 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Ruxolitinib Phosphate)</title>
            <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Treatment</title>
          <description>Number of months to subsequent therapy per patient.</description>
          <units>Months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Ruxolitinib Phosphate)</title>
          <description>Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.&#xD;
Ruxolitinib: Given PO&#xD;
Ruxolitinib Phosphate: Given PO</description>
        </group>
      </group_list>
      <serious_events>
        <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="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </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="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </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>Zeev Extrov MD./Professor</name_or_title>
      <organization>The University of Texas MD Anderson Cancer Center</organization>
      <phone>713-794-1675</phone>
      <email>zestrov@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/NCT03041636
org study id: 2015-0570
secondary id: NCI-2017-00478
secondary id: 2015-0570
nct id: NCT03041636
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well ruxolitinib phosphate works in treating patients with
      previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. Ruxolitinib
      phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell
      growth.
PRIMARY OBJECTIVES:

      I. To determine the effect of ruxolitinib phosphate (ruxolitinib) in patients with high-risk
      chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who do not require
      anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic
      Leukemia (IWCLL) 2008 recommendations and were either previously untreated or treated with
      Ibrutinib for less than 3 months and were deemed Ibrutinib intolerant:

      Ia. On disease burden. Ib. The rate of complete response (CR) and partial response (PR) as
      assessed by the IWCLL 2008 response criteria.

      SECONDARY OBJECTIVES:

      I. To evaluate the time to next treatment of high-risk CLL/SLL who do not require
      anti-neoplastic therapy according to the IWCLL 2008 recommendations.

      OUTLINE:

      Patients receive ruxolitinib phosphate orally (PO) twice daily (BID). Treatment continues for
      up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment
      beyond 3 years may be permitted after discussion with the principal investigator.

      After completion of study treatment, patients are followed up at 30 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participants With a Clinical Response
time frame: Up to 6 months after initiation of therapy
description: Clinical response will be assessed based on physical examination, complete blood count (CBC), a bone marrow aspiration, a whole body CT scan to be done at screening and 6 + 2 months in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines (Hallek et al., 2008)
measure: Number of Participants With Change of Tumor Burden
time frame: 6 months after initiation of therapy
description: Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.
measure: Participants With a Response
time frame: Up to 30 days
description: Response Rate is Complete Response (CR) or Partial Response (PR). CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes < 4000/ul, normocellular, <30% lymphocytes, no B-lymphoid nodules, Platelets > 100,000/ul, hemoglobin >11.0 g/dl and Neutrophils >1500/ul.
PR is >/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count > 100,000/ul, Hemoglobin > 11 g/dl and Neutrophils >1500/ul or increase >/= 50% of all over base.
measure: Time to Next Treatment
time frame: Up to 30 days
description: Number of months to subsequent therapy per patient.
arm group label: Treatment (ruxolitinib phosphate)
arm group type: Experimental
description: Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator.
intervention type: Drug
intervention name: Ruxolitinib
description: Given PO
arm group label: Treatment (ruxolitinib phosphate)
other name: INCB-18424
other name: INCB18424
other name: Oral JAK Inhibitor INCB18424
intervention type: Drug
intervention name: Ruxolitinib Phosphate
description: Given PO
arm group label: Treatment (ruxolitinib phosphate)
other name: INCB-18424 Phosphate
other name: Jakafi
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zeev Estrov
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: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Janus Kinase Inhibitors
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 