<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/NCT02974647</url>
  </required_header>
  <id_info>
    <org_study_id>16-1542</org_study_id>
    <nct_id>NCT02974647</nct_id>
  </id_info>
  <brief_title>Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma</brief_title>
  <official_title>Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to test any good and bad effects of the study drug called&#xD;
      ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another&#xD;
      protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking&#xD;
      JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease control rate</measure>
    <time_frame>2 years</time_frame>
    <description>defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">82</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>rel/ref PTCLtumors are known to contain mutations associ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>with rel/ref PTCL with functional evidence of JAK/STAT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>with rel/ref PTCL who do not meet criteria for cohort 1 or 2.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rare sub-type expansion cohort: T-PLL and T-LGL &amp; any T-Cell/NK Lymphoma with JAK fusion mutations.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib</intervention_name>
    <arm_group_label>Rare sub-type expansion cohort: T-PLL and T-LGL &amp; any T-Cell/NK Lymphoma with JAK fusion mutations.</arm_group_label>
    <arm_group_label>rel/ref PTCLtumors are known to contain mutations associ</arm_group_label>
    <arm_group_label>with rel/ref PTCL who do not meet criteria for cohort 1 or 2.</arm_group_label>
    <arm_group_label>with rel/ref PTCL with functional evidence of JAK/STAT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed T or NK cell lymphoma at the enrolling institution. For CTCL,&#xD;
             patients with stage IB disease or greater are eligible.&#xD;
&#xD;
          -  Relapse or refractory disease after at least 1 systemic therapy except for T-PLL where&#xD;
             untreated patients may be allowed after discussion with P.I.&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  ECOG ≤ 2&#xD;
&#xD;
          -  Measurable disease defined by:&#xD;
&#xD;
               -  Lugano Classification for systemic lymphoma or&#xD;
&#xD;
               -  Atypical and or malignant lymphocytes quantifiable by flow cytometry or&#xD;
                  morphology in blood or bone marrow or&#xD;
&#xD;
               -  mSWAT &gt; 0 or Sezary count ≥ 1000 cells/μL for CTCL&#xD;
&#xD;
          -  Previous systemic anti-cancer therapy for T-cell lymphoma must have been discontinued&#xD;
             at least 2 weeks prior to treatment.&#xD;
&#xD;
               -  Glucocorticoids aimed at controlling lymphoma-related symptoms are allowed as&#xD;
                  long as they are tapered down to 20mg or less by the time of ruxolitiib&#xD;
                  initiation&#xD;
&#xD;
               -  Topical steroids for CTCL are permitted&#xD;
&#xD;
               -  See section 6.2 Subject Exclusion Criteria for guideline regarding adjuvant and&#xD;
                  maintenance therapy for prior malignancy&#xD;
&#xD;
          -  Patients must meet the following lab criteria:&#xD;
&#xD;
               -  ANC ≥ 1.0/mm^3 or ANC &gt;/= 0.5/mm^3 (if patient has baseline neutropenia due to&#xD;
                  lymphoma), platelets ≥ 100 x 10^9/L or ≥ 50 x 10^9/L (if related to lymphoma),&#xD;
                  Hgb ≥ 8g/dL&#xD;
&#xD;
               -  Patients with LGL or T-PLL are not required to meet a minimum ANC or hemoglobin&#xD;
                  value for eligibility&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or; ≤ 3 x ULN if documented&#xD;
                  hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's ; AST and&#xD;
                  ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma involvement&#xD;
&#xD;
               -  Creatinine clearance ≥ 30 mL/min; creatinine clearance of 15-29 mL/min will be&#xD;
                  allowed as long as baseline platelets are ≥ 150 x 10^9/L&#xD;
&#xD;
          -  For patients with positive hepatitis B core antibody or surface antigen, hepatitis B&#xD;
             PCR must be negative and prophylaxis with entecavir or equivalent is required.&#xD;
&#xD;
          -  Patients with HIV are allowed provided that they are on anti-retroviral treatment with&#xD;
             no active infections.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that&#xD;
             would prevent the subject from signing the informed consent form.&#xD;
&#xD;
          -  Uncontrolled concurrent illness including, but not limited to, ongoing or active&#xD;
             infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements.&#xD;
&#xD;
          -  ECOG performance status &gt;2&#xD;
&#xD;
          -  Prior therapy with ruxolitinib&#xD;
&#xD;
          -  Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma)&#xD;
&#xD;
               -  Patients with more than one type of lymphoma may be enrolled after discussion&#xD;
                  with the MSK Principal Investigator&#xD;
&#xD;
               -  Adjuvant or maintenance therapy to reduce the risk of recurrence of other&#xD;
                  malignancy (other than T-cell lymphoma) is permissible after discussion with the&#xD;
                  MSK principal Investigator&#xD;
&#xD;
          -  Women of reproductive potential† must have a negative Serum ß human chorionic&#xD;
             gonadotropin (ß-HCG) pregnancy test.&#xD;
&#xD;
               -  A female of reproductive potential is a sexually mature female who: has not&#xD;
                  undergone a hysterectomy or bilateral oophorectomy; or has not been naturally&#xD;
                  postmenopausal for at least 24 consecutive months (i.e. has had menses at any&#xD;
                  time in the preceding 24 consecutive months).&#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>Alison Moskowitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alison Moskowitz, MD</last_name>
    <phone>212-639-4839</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steven Horwitz, MD</last_name>
    <phone>212-639-3045</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine (Data collection and specimen analysis)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaehyuk Choi, MD, PhD</last_name>
      <phone>312-695-8106</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Jacobsen, MD</last_name>
      <phone>617-582-9086</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Moskowitz, MD</last_name>
      <phone>212-639-4839</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (All Protocol Activities)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Moskowitz, MD</last_name>
      <phone>212-639-4839</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Moskowitz, MD</last_name>
      <phone>212-639-4839</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Moskowitz, MD</last_name>
      <phone>212-639-4839</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Moskowitz, MD</last_name>
      <phone>212-639-4839</phone>
    </contact>
    <contact_backup>
      <last_name>Steven Horwitz, MD</last_name>
      <phone>212-639-3045</phone>
    </contact_backup>
    <investigator>
      <last_name>Allison Moskowitz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (All Protocol Activities)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Moskowitz, MD</last_name>
      <phone>212-639-4839</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ruxolitinib</keyword>
  <keyword>T or NK Cell</keyword>
  <keyword>Relapsed</keyword>
  <keyword>Refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02974647
org study id: 16-1542
nct id: NCT02974647
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
The purpose of this study is to test any good and bad effects of the study drug called
      ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another
      protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking
      JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: disease control rate
time frame: 2 years
description: defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold.
arm group label: rel/ref PTCLtumors are known to contain mutations associ
arm group type: Experimental
description: Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
arm group label: with rel/ref PTCL with functional evidence of JAK/STAT
arm group type: Experimental
description: Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
arm group label: with rel/ref PTCL who do not meet criteria for cohort 1 or 2.
arm group type: Experimental
description: Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
arm group label: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.
arm group type: Experimental
description: Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
intervention type: Drug
intervention name: Ruxolitinib
arm group label: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.
arm group label: rel/ref PTCLtumors are known to contain mutations associ
arm group label: with rel/ref PTCL who do not meet criteria for cohort 1 or 2.
arm group label: with rel/ref PTCL with functional evidence of JAK/STAT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alison Moskowitz, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Alison Moskowitz, MD
phone: 212-639-4839
last name: Steven Horwitz, MD
phone: 212-639-3045
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Lymphoma