<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/NCT02232516</url>
  </required_header>
  <id_info>
    <org_study_id>NU 14H04</org_study_id>
    <secondary_id>NCI-2014-01770</secondary_id>
    <secondary_id>RV-CL-PTCL-PI-003974</secondary_id>
    <secondary_id>STU00097620</secondary_id>
    <secondary_id>P30CA060553</secondary_id>
    <nct_id>NCT02232516</nct_id>
  </id_info>
  <brief_title>Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma</brief_title>
  <official_title>Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate how safe and effective the combination of the study&#xD;
      drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma&#xD;
      (PTCL) who have not been previously treated for this cancer. Currently, there is no standard&#xD;
      treatment for patients with PTCL; the most common treatment used is a combination of drugs&#xD;
      called CHOP, but this can be a difficult treatment to tolerate because of side effects, and&#xD;
      is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of&#xD;
      drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that&#xD;
      can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide&#xD;
      (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug&#xD;
      affects how tumor cells grow and survive, including affecting blood vessel growth in tumors.&#xD;
      It is given as an oral tablet (by mouth).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients&#xD;
      with previously untreated peripheral T-cell lymphoma (PTCL).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate the safety of the combination of romidepsin and lenalidomide. II. Further&#xD;
      evaluate efficacy of the combination of romidepsin and lenalidomide.&#xD;
&#xD;
      III. Evaluate the delay to cytotoxic chemotherapy.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate the use of Northwestern Medicine (NM) positron emission tomography (PET)/computed&#xD;
      tomography (CT) vs CT imaging in PTCL.&#xD;
&#xD;
      II. Validate a new prognostic model for newly diagnosed PTCL. III. Investigate the tumor&#xD;
      immunohistochemical profile to identify potential biomarkers associated with prognosis and&#xD;
      treatment response.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15 and&#xD;
      lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up&#xD;
      to 1 year in the absence of disease progression, inter-current illness that prevents further&#xD;
      administration of treatment, unacceptable toxicity, patient decides to withdraw from study&#xD;
      treatment (or study as a whole), or general or specific changes in the patient's condition&#xD;
      render the patient unacceptable for further treatment in the judgment of the treating&#xD;
      investigator.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for 1 year and&#xD;
      then every 6 months for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Objective response rate (ORR), as defined per Cheson criteria</measure>
    <time_frame>Assessed after cycles 3 and 6, then every 6 months up to 3 years</time_frame>
    <description>ORR will be assessed by imaging after cycles 3 and 6, and then every 6 months up to 3 years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0</measure>
    <time_frame>Evaluated once per cycle (1 cycle=28 days) up to 1 year</time_frame>
    <description>The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Reported at 1 and 3 years after the start of treatment</time_frame>
    <description>PFS will be evaluated at 1 and 3 years after treatment has begun.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Reported at 1 and 3 years after the start of treatment</time_frame>
    <description>OS will be assessed at 1 and 3 years after treatment has begun.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response, defined per Cheson criteria</measure>
    <time_frame>Assessed from start of therapy for up to 3 years</time_frame>
    <description>The duration of overall response is measured from the time measurement criteria are met for Complete Remission or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay to cytotoxic chemotherapy</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Time to first cytotoxic chemotherapy is defined as the time (in months) from start of study treatment to time of first dose of anti-neoplastic cytotoxic chemotherapy that is administered to treat lymphoma.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>NM PET/CT vs. CT imaging in PTCL</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To evaluate the use of NM PET/CT vs CT imaging in PTCL, a review of the utilized imaging modalities during treatment as a tool of response assessment will be done. When both imaging modalities are chosen for a patient, response assessment will be compared.</description>
  </other_outcome>
  <other_outcome>
    <measure>Validate a new prognostic model for newly diagnosed PTCL</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Clinical biomarkers including age, race, histology, and stage as an assessment of prognosis. A points based system will be used to correlate with recently developed prognostic model.</description>
  </other_outcome>
  <other_outcome>
    <measure>Immunohistochemistry profile</measure>
    <time_frame>Baseline</time_frame>
    <description>To investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response. Archived tissue samples collected at baseline will be evaluated in order to determine how marker expression correlates with clinical outcome.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Adult Nasal Type Extranodal NK/T-cell Lymphoma</condition>
  <condition>Anaplastic Large Cell Lymphoma</condition>
  <condition>Angioimmunoblastic T-cell Lymphoma</condition>
  <condition>Hepatosplenic T-cell Lymphoma</condition>
  <condition>Peripheral T-cell Lymphoma</condition>
  <condition>Stage I Cutaneous T-cell Non-Hodgkin Lymphoma</condition>
  <condition>Stage IA Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage IB Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage II Cutaneous T-cell Non-Hodgkin Lymphoma</condition>
  <condition>Stage IIA Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage IIB Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage III Cutaneous T-cell Non-Hodgkin Lymphoma</condition>
  <condition>Stage IIIA Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage IIIB Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma</condition>
  <condition>Stage IVA Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Stage IVB Mycosis Fungoides/Sezary Syndrome</condition>
  <arm_group>
    <arm_group_label>Treatment (romidepsin, lenalidomide)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>romidepsin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (romidepsin, lenalidomide)</arm_group_label>
    <other_name>FK228</other_name>
    <other_name>FR901228</other_name>
    <other_name>Istodax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lenalidomide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (romidepsin, lenalidomide)</arm_group_label>
    <other_name>CC-5013</other_name>
    <other_name>IMiD-1</other_name>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (romidepsin, lenalidomide)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of PTCL (using the most recent edition of the World&#xD;
             Health Organization [WHO] Classification of Tumors of Hematopoietic and Lymphoid&#xD;
             Tissues as guidance) including:&#xD;
&#xD;
               -  Anaplastic large cell lymphoma, anaplastic large cell kinase (ALK)-negative&#xD;
&#xD;
               -  Angioimmunoblastic T-cell lymphoma&#xD;
&#xD;
               -  Enteropathy-type T-cell lymphoma&#xD;
&#xD;
               -  Extranodal natural killer (NK)/T-cell lymphoma, nasal type&#xD;
&#xD;
               -  Hepatosplenic gamma-delta T-cell lymphoma&#xD;
&#xD;
               -  Peripheral T-cell lymphoma, unspecified (not otherwise specified [NOS])&#xD;
&#xD;
               -  Transformed mycosis fungoides&#xD;
&#xD;
               -  Subcutaneous panniculitis-like T-cell lymphoma.&#xD;
&#xD;
               -  NOTE: A copy of the pathology report is sufficient to register the patient to the&#xD;
                  trial; diagnosis of PTCL should have been based on identification in biopsy&#xD;
                  specimens of a peripheral T-cell lymphoma disorder characterized by positivity in&#xD;
                  the malignant cell population of at least 3 of the following T-cell markers:&#xD;
                  betaF1, cluster of differentiation (CD)2, CD3, CD4, CD5, CD7, CD8, and negativity&#xD;
                  of at least 2 of the following B-cell markers CD19, CD20, CD79alpha and paired&#xD;
                  box 5 (Pax-5); further, CD56 should be used for the diagnosis of the nasal type,&#xD;
                  while CD30, ALK-1 and Pax-5 (that should be negative) are required for the&#xD;
                  anaplastic type; CD10, chemokine (C-X-C motif) ligand 13 (CXCL13), programmed&#xD;
                  cell death (PD)-1 and CD21 are warranted for the diagnosis of angioimmunoblastic&#xD;
                  T-cell lymphoma along with Epstein-Barr virus-encoded small ribonucleic acid&#xD;
                  (RNA) (EBER) in situ hybridization; determination of mindbomb E3 ubiquitin&#xD;
                  protein ligase 1(Mib-1)/marker of proliferation Ki-67 (Ki-67) to be performed;&#xD;
                  finally, additional markers useful within the context of anaplastic large cell&#xD;
                  lymphoma, extranodal NK/T-cell lymphoma and subcutaneous panniculitis-like T-cell&#xD;
                  lymphoma are TIA1 cytotoxic granule-associated RNA binding protein (TIA-1),&#xD;
                  granzyme B and perforin; it is acknowledged that no marker has absolute lineage&#xD;
                  specificity, and that immunophenotypic studies should be performed with panels of&#xD;
                  monoclonal antibodies; final diagnoses containing caveats such as &quot;suspicious of&quot;&#xD;
                  or &quot;presumably&quot; are considered inadequate for a patient to be enrolled in the&#xD;
                  trial&#xD;
&#xD;
               -  NOTE: Patients with adequate archived (well-preserved, formalin-fixed) biopsy&#xD;
                  tissue remaining will be required to submit a portion for exploratory studies;&#xD;
                  this is not optional if tissue is available; however, lack of adequate tissue for&#xD;
                  exploratory studies will not preclude patients from participating&#xD;
&#xD;
          -  Patients must have bi-dimensionally measurable disease (&gt;= 1 cm) by CT imaging&#xD;
&#xD;
               -  NOTE: Patients with marrow-only disease are eligible; response for these patients&#xD;
                  will be assessed by repeat bone marrow biopsy&#xD;
&#xD;
          -  Patients must fit into one of the following categories:&#xD;
&#xD;
               -  Age &gt;= 18 years to &lt; 60 years with a cumulative illness rating scale (CIRS) score&#xD;
                  &gt;= 6 OR deemed ineligible for cytotoxic chemotherapy by the treating investigator&#xD;
&#xD;
               -  &gt;= 60 years&#xD;
&#xD;
          -  Patients must have adequate organ and marrow function (documented within 14 days prior&#xD;
             to registration) as outlined below:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &gt;= 750/mcl&#xD;
&#xD;
               -  Hemoglobin &gt;= 8 g/dl&#xD;
&#xD;
               -  Platelets &gt;= 50,000/mcl&#xD;
&#xD;
               -  Total bilirubin =&lt; 2 x upper limit normal (ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])&#xD;
                  and alanine aminotransferase (ALT) (serum pyruvate glutamate transaminase [SPGT])&#xD;
                  =&lt; 3 x ULN&#xD;
&#xD;
               -  Creatinine =&lt; 2 x ULN&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =&lt;&#xD;
             2&#xD;
&#xD;
          -  All patients must agree to use effective contraception while on study, and all&#xD;
             patients must agree to undergo counseling sessions every 28 days about pregnancy&#xD;
             precautions and risks of fetal exposure&#xD;
&#xD;
               -  Females of childbearing potential (FCBP) must either commit to continued&#xD;
                  abstinence from heterosexual intercourse or begin TWO acceptable methods of birth&#xD;
                  control: one highly effective method and one additional effective method AT THE&#xD;
                  SAME TIME, at least 28 days before starting lenalidomide, during lenalidomide&#xD;
                  therapy, during dose interruptions, and for at least 28 days following&#xD;
                  discontinuation of lenalidomide therapy&#xD;
&#xD;
               -  Males receiving lenalidomide must agree to use a latex condom during any sexual&#xD;
                  contact with FCBPs even if they have undergone a successful vasectomy&#xD;
&#xD;
               -  NOTE: A FCBP is any woman (regardless of sexual orientation, having undergone a&#xD;
                  tubal ligation, or remaining celibate by choice) who meets the following&#xD;
                  criteria:&#xD;
&#xD;
                    -  Has not undergone a hysterectomy or bilateral oophorectomy&#xD;
&#xD;
                    -  Has not been naturally postmenopausal for at least 12 consecutive months&#xD;
                       (i.e., has had menses at any time in the preceding 12 consecutive months)&#xD;
&#xD;
               -  FCBP should be referred to a qualified provider of contraceptive methods, if&#xD;
                  needed&#xD;
&#xD;
          -  FCPB must have a negative urine or serum pregnancy test within 7 days prior to&#xD;
             registration, and be willing to adhere to the scheduled pregnancy testing as required&#xD;
             in the Revlimid Risk Evaluation and Mitigation Strategies (REMS®) program&#xD;
&#xD;
               -  NOTE: Should a woman become pregnant or suspect she is pregnant while&#xD;
                  participating in this study, she should inform her treating physician immediately&#xD;
&#xD;
          -  Patients must be free of any prior malignancies for &gt;= 1 year&#xD;
&#xD;
               -  NOTE: The exception to this would be currently treated squamous cell and basal&#xD;
                  cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder,&#xD;
                  or surgically removed melanoma in situ of the skin (stage 0) with histologically&#xD;
                  confirmed free margins of excision&#xD;
&#xD;
          -  All study participants must be registered into the mandatory Revlimid REMS® program,&#xD;
             and be willing and able to comply with the requirements of the REMS® program&#xD;
&#xD;
          -  Patients must have the ability to understand and the willingness to sign a written&#xD;
             informed consent prior to registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of any of the following are not eligible:&#xD;
&#xD;
               -  Anaplastic large cell lymphoma, ALK-positive&#xD;
&#xD;
               -  Adult T-cell lymphoma/leukemia (ATLL)&#xD;
&#xD;
               -  Anaplastic large-cell lymphoma, primary cutaneous type&#xD;
&#xD;
               -  Precursor T-lymphoblastic lymphoma/leukemia&#xD;
&#xD;
               -  Mycosis fungoides/Sezary syndrome (except transformed Mycosis fungoides [MF])&#xD;
&#xD;
               -  NK-cell leukemia&#xD;
&#xD;
               -  T-cell granular lymphocytic leukemia&#xD;
&#xD;
               -  T-cell prolymphocytic leukemia&#xD;
&#xD;
          -  Patients must not have received prior systemic therapy for PTCL (except for&#xD;
             corticosteroids for 10 or fewer days at any dose, no washout period required as long&#xD;
             as they discontinue prior to starting study therapy); NOTE: topical treatment may have&#xD;
             been given for prior existence of cutaneous lymphoma that has since become systemic&#xD;
             PTCL; however, these topical therapies should be stopped at time of registration&#xD;
&#xD;
          -  Patients who received chemotherapy (including monoclonal antibodies) or radiotherapy,&#xD;
             administered for any condition, within 4 weeks prior to registration are not eligible&#xD;
&#xD;
          -  Patients who received prior exposure to any other histone deacetylase (HDAC)&#xD;
             inhibitors or immunomodulatory (IMID) agents for any reason are not eligible&#xD;
&#xD;
          -  Patients receiving ongoing treatment with any other investigational agents are not&#xD;
             eligible&#xD;
&#xD;
          -  Patients who have known central nervous system (CNS) involvement of lymphoma are not&#xD;
             eligible&#xD;
&#xD;
          -  Patients who have an uncontrolled intercurrent illness including, but not limited to,&#xD;
             any of the following are not eligible:&#xD;
&#xD;
               -  Ongoing or active infection&#xD;
&#xD;
               -  Symptomatic congestive heart failure&#xD;
&#xD;
               -  Unstable angina pectoris&#xD;
&#xD;
               -  Cardiac arrhythmia&#xD;
&#xD;
               -  Psychiatric illness/social situations that would limit compliance with study&#xD;
                  requirements&#xD;
&#xD;
          -  Patients with a known human immunodeficiency (HIV) infection are not eligible&#xD;
&#xD;
          -  Patients who are pregnant or actively nursing an infant are not eligible&#xD;
&#xD;
          -  Patients with a QT interval &gt; 500 msec (using the Bazett's formula) within 28 days&#xD;
             prior to registration are not eligible&#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>Barbara Pro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 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>Mycoses</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Mycosis Fungoides</mesh_term>
    <mesh_term>Sezary Syndrome</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
    <mesh_term>Lymphoma, Large-Cell, Anaplastic</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</mesh_term>
    <mesh_term>Immunoblastic Lymphadenopathy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Romidepsin</mesh_term>
  </intervention_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/NCT02232516
org study id: NU 14H04
secondary id: NCI-2014-01770
secondary id: RV-CL-PTCL-PI-003974
secondary id: STU00097620
secondary id: P30CA060553
nct id: NCT02232516
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate how safe and effective the combination of the study
      drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma
      (PTCL) who have not been previously treated for this cancer. Currently, there is no standard
      treatment for patients with PTCL; the most common treatment used is a combination of drugs
      called CHOP, but this can be a difficult treatment to tolerate because of side effects, and
      is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of
      drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that
      can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide
      (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug
      affects how tumor cells grow and survive, including affecting blood vessel growth in tumors.
      It is given as an oral tablet (by mouth).
PRIMARY OBJECTIVES:

      I. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients
      with previously untreated peripheral T-cell lymphoma (PTCL).

      SECONDARY OBJECTIVES:

      I. Evaluate the safety of the combination of romidepsin and lenalidomide. II. Further
      evaluate efficacy of the combination of romidepsin and lenalidomide.

      III. Evaluate the delay to cytotoxic chemotherapy.

      TERTIARY OBJECTIVES:

      I. Evaluate the use of Northwestern Medicine (NM) positron emission tomography (PET)/computed
      tomography (CT) vs CT imaging in PTCL.

      II. Validate a new prognostic model for newly diagnosed PTCL. III. Investigate the tumor
      immunohistochemical profile to identify potential biomarkers associated with prognosis and
      treatment response.

      OUTLINE:

      Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15 and
      lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up
      to 1 year in the absence of disease progression, inter-current illness that prevents further
      administration of treatment, unacceptable toxicity, patient decides to withdraw from study
      treatment (or study as a whole), or general or specific changes in the patient's condition
      render the patient unacceptable for further treatment in the judgment of the treating
      investigator.

      After completion of study treatment, patients are followed up every 3 months for 1 year and
      then every 6 months for 3 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR), as defined per Cheson criteria
time frame: Assessed after cycles 3 and 6, then every 6 months up to 3 years
description: ORR will be assessed by imaging after cycles 3 and 6, and then every 6 months up to 3 years.
measure: Incidence of toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
time frame: Evaluated once per cycle (1 cycle=28 days) up to 1 year
description: The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution.
measure: Progression-free survival (PFS)
time frame: Reported at 1 and 3 years after the start of treatment
description: PFS will be evaluated at 1 and 3 years after treatment has begun.
measure: Overall survival (OS)
time frame: Reported at 1 and 3 years after the start of treatment
description: OS will be assessed at 1 and 3 years after treatment has begun.
measure: Duration of response, defined per Cheson criteria
time frame: Assessed from start of therapy for up to 3 years
description: The duration of overall response is measured from the time measurement criteria are met for Complete Remission or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
measure: Delay to cytotoxic chemotherapy
time frame: Up to 1 year
description: Time to first cytotoxic chemotherapy is defined as the time (in months) from start of study treatment to time of first dose of anti-neoplastic cytotoxic chemotherapy that is administered to treat lymphoma.
measure: NM PET/CT vs. CT imaging in PTCL
time frame: Up to 3 years
description: To evaluate the use of NM PET/CT vs CT imaging in PTCL, a review of the utilized imaging modalities during treatment as a tool of response assessment will be done. When both imaging modalities are chosen for a patient, response assessment will be compared.
measure: Validate a new prognostic model for newly diagnosed PTCL
time frame: Up to 3 years
description: Clinical biomarkers including age, race, histology, and stage as an assessment of prognosis. A points based system will be used to correlate with recently developed prognostic model.
measure: Immunohistochemistry profile
time frame: Baseline
description: To investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response. Archived tissue samples collected at baseline will be evaluated in order to determine how marker expression correlates with clinical outcome.
arm group label: Treatment (romidepsin, lenalidomide)
arm group type: Experimental
description: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: romidepsin
description: Given IV
arm group label: Treatment (romidepsin, lenalidomide)
other name: FK228
other name: FR901228
other name: Istodax
intervention type: Drug
intervention name: lenalidomide
description: Given PO
arm group label: Treatment (romidepsin, lenalidomide)
other name: CC-5013
other name: IMiD-1
other name: Revlimid
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Treatment (romidepsin, lenalidomide)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Pro, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Mycosis Fungoides
mesh term: Sezary Syndrome
mesh term: Lymphoma, T-Cell, Cutaneous
mesh term: Lymphoma, Large-Cell, Anaplastic
mesh term: Lymphoma, Extranodal NK-T-Cell
mesh term: Immunoblastic Lymphadenopathy
mesh term: Syndrome
mesh term: Lenalidomide
mesh term: Romidepsin