<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/NCT01722305</url>
  </required_header>
  <id_info>
    <org_study_id>MC1281</org_study_id>
    <secondary_id>NCI-2012-01948</secondary_id>
    <secondary_id>MC1281</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT01722305</nct_id>
  </id_info>
  <brief_title>Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma</brief_title>
  <official_title>Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of pomalidomide when given together&#xD;
      with dexamethasone in treating patients with primary central nervous system lymphoma that has&#xD;
      come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma&#xD;
      that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system&#xD;
      to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different&#xD;
      ways to stop the growth of cancer cells, either by killing the cells, stopping them from&#xD;
      dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone&#xD;
      may kill more cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To establish the maximum tolerated dose (MTD) of pomalidomide in combination with&#xD;
      dexamethasone in patients with relapsed/refractory primary central nervous system lymphoma&#xD;
      (PCNSL) or primary vitreoretinal lymphoma (PVRL).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the efficacy (overall response rate) and safety of pomalidomide in combination&#xD;
      with dexamethasone in patients with PCNSL and PVRL lymphoma in an MTD expanded cohort.&#xD;
&#xD;
      II. To evaluate overall survival and progression free survival.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To study the pharmacokinetics of pomalidomide in the central nervous system. II. To&#xD;
      identify the predictive biomarkers for responsiveness to pomalidomide.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of pomalidomide.&#xD;
&#xD;
      Patients receive pomalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15,&#xD;
      and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression&#xD;
      or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 6 months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2013</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2016</primary_completion_date>
  <phase>Phase 1</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>MTD of pomalidomide when given in combination with dexamethasone determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0</measure>
    <time_frame>28 days</time_frame>
    <description>The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level. The grade 3+ adverse events will also be described and summarized in a similar fashion. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events, graded according to CTCAE 4.0</measure>
    <time_frame>Up to 30 days post-treatment</time_frame>
    <description>The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate defined as number of patients with an objective status of complete response (CR), complete response/unconfirmed (Cru), or partial response (PR) divided by total number of evaluable patients</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Exact binomial 95% confidence intervals for the true overall response rate will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival time</measure>
    <time_frame>Time from registration to death due to any cause, assessed up to 2 years</time_frame>
    <description>The distribution of overall survival will be estimated using the method of Kaplan-Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Time from registration to progression or death due to PCNSL or PVRL lymphoma, assessed up to 2 years</time_frame>
    <description>The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pharmacokinetics of pomalidomide in the CNS</measure>
    <time_frame>Up to day 22 of course 1</time_frame>
    <description>Based on pomalidomide levels in blood and CSF at different time points, area under curve will be determined.</description>
  </other_outcome>
  <other_outcome>
    <measure>Predictive biomarkers for response to pomalidomide</measure>
    <time_frame>Up to day 21 of course 1</time_frame>
    <description>Correlation studies will be performed to identify predictive immune markers for response to pomalidomide. Immune cell counts and cytokine profile will be evaluated in blood and CSF at day 1 and day 21 of course 1. Values at each time point and changes after pomalidomide treatment will be both graphically and quantitatively summarized and explored. Wilcoxon rank sum test and Fisher's exact test will be utilized where appropriate to assess the relationships of these markers with response.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma</condition>
  <condition>Central Nervous System Lymphoma</condition>
  <condition>Intraocular Lymphoma</condition>
  <condition>Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System</condition>
  <condition>Recurrent Adult Diffuse Large Cell Lymphoma</condition>
  <condition>Retinal Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (pomalidomide, dexamethasone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive pomalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (pomalidomide, dexamethasone)</arm_group_label>
    <other_name>Aacidexam</other_name>
    <other_name>Adexone</other_name>
    <other_name>Aknichthol Dexa</other_name>
    <other_name>Alba-Dex</other_name>
    <other_name>Alin</other_name>
    <other_name>Alin Depot</other_name>
    <other_name>Alin Oftalmico</other_name>
    <other_name>Amplidermis</other_name>
    <other_name>Anemul mono</other_name>
    <other_name>Auricularum</other_name>
    <other_name>Auxiloson</other_name>
    <other_name>Baycuten</other_name>
    <other_name>Baycuten N</other_name>
    <other_name>Cortidexason</other_name>
    <other_name>Cortisumman</other_name>
    <other_name>Decacort</other_name>
    <other_name>Decadrol</other_name>
    <other_name>Decadron</other_name>
    <other_name>Decalix</other_name>
    <other_name>Decameth</other_name>
    <other_name>Decasone R.p.</other_name>
    <other_name>Dectancyl</other_name>
    <other_name>Dekacort</other_name>
    <other_name>Deltafluorene</other_name>
    <other_name>Deronil</other_name>
    <other_name>Desamethasone</other_name>
    <other_name>Desameton</other_name>
    <other_name>Dexa-Mamallet</other_name>
    <other_name>Dexa-Rhinosan</other_name>
    <other_name>Dexa-Scheroson</other_name>
    <other_name>Dexa-sine</other_name>
    <other_name>Dexacortal</other_name>
    <other_name>Dexacortin</other_name>
    <other_name>Dexafarma</other_name>
    <other_name>Dexafluorene</other_name>
    <other_name>Dexalocal</other_name>
    <other_name>Dexamecortin</other_name>
    <other_name>Dexameth</other_name>
    <other_name>Dexamethasonum</other_name>
    <other_name>Dexamonozon</other_name>
    <other_name>Dexapos</other_name>
    <other_name>Dexinoral</other_name>
    <other_name>Dexone</other_name>
    <other_name>Dinormon</other_name>
    <other_name>Fluorodelta</other_name>
    <other_name>Fortecortin</other_name>
    <other_name>Gammacorten</other_name>
    <other_name>Hexadecadrol</other_name>
    <other_name>Hexadrol</other_name>
    <other_name>Lokalison-F</other_name>
    <other_name>Loverine</other_name>
    <other_name>Methylfluorprednisolone</other_name>
    <other_name>Millicorten</other_name>
    <other_name>Mymethasone</other_name>
    <other_name>Orgadrone</other_name>
    <other_name>Spersadex</other_name>
    <other_name>Visumetazone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Optional correlative studies</description>
    <arm_group_label>Treatment (pomalidomide, dexamethasone)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacological Study</intervention_name>
    <description>Optional correlative studies</description>
    <arm_group_label>Treatment (pomalidomide, dexamethasone)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (pomalidomide, dexamethasone)</arm_group_label>
    <other_name>4-Aminothalidomide</other_name>
    <other_name>Actimid</other_name>
    <other_name>CC-4047</other_name>
    <other_name>Imnovid</other_name>
    <other_name>Pomalyst</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsed or refractory primary central nervous system (CNS) diffuse large B cell&#xD;
             lymphoma (PCNSDLBCL) with a CNS lesion, with cerebrospinal fluid (CSF) relapse with&#xD;
             positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy;&#xD;
             NOTE: tissue biopsy is not absolutely necessary for CNS tumor unless clinical and&#xD;
             radiologic findings strongly suggest other etiologies as per treating physician;&#xD;
             initial diagnosis must be made by tissue biopsy; NOTE: patients with B-cell lymphoma&#xD;
             with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma&#xD;
             are also eligible for the protocol as long as they meet other criteria; patients with&#xD;
             typical Burkitt lymphoma are not eligible&#xD;
&#xD;
          -  Relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma (DLBCL) with a&#xD;
             CNS lesion, with CSF relapse with positive CSF cytology, or with ocular relapse with&#xD;
             positive ocular tissue biopsy; NOTE: tissue biopsy requirement of the CNS lesion is as&#xD;
             outlined in bullet above&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1000/uL&#xD;
&#xD;
          -  Platelets (PLT) &gt;= 100,000/uL&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN) or if total bilirubin is &gt; 1.5 x&#xD;
             ULN the direct bilirubin must be =&lt; 1.5 x ULN (=&lt; 0.45 mg/dL)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) =&lt; 3 x ULN&#xD;
&#xD;
          -  Creatinine =&lt; 2.5 x ULN&#xD;
&#xD;
          -  Females of reproductive potential must be willing to adhere to the scheduled pregnancy&#xD;
             testing as required in the POMALYST REMS (TM) program&#xD;
&#xD;
          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients&#xD;
             intolerant to acetylsalicylic acid [ASA] may use warfarin or heparin)&#xD;
&#xD;
          -  Provide informed written consent&#xD;
&#xD;
          -  Willing to return to participating medical institutions for follow-up&#xD;
&#xD;
          -  Willing to provide tissue samples for correlative research purposes&#xD;
&#xD;
          -  Willing to be registered into the mandatory POMALYST REMS (TM) program, and willing&#xD;
             and able to comply with the requirements of the POMALYST REMS (TM) program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following&#xD;
&#xD;
               -  Pregnant women&#xD;
&#xD;
               -  Nursing women&#xD;
&#xD;
               -  Men or women of childbearing potential who are unwilling to employ adequate&#xD;
                  contraception&#xD;
&#xD;
          -  The development of erythema nodosum if characterized by a desquamating rash while&#xD;
             taking thalidomide or similar drugs&#xD;
&#xD;
          -  Uncontrolled infection&#xD;
&#xD;
          -  Therapy with myelosuppressive chemotherapy or biologic therapy &lt; 21 days prior to&#xD;
             registration; NOTE: patients who have recovered from cytopenia related to previous&#xD;
             treatment and meet criteria of this protocol will be eligible&#xD;
&#xD;
          -  Persistent toxicities &gt;= grade 3 from prior chemotherapy or biological therapy&#xD;
             regardless of interval since last treatment&#xD;
&#xD;
          -  History of thromboembolic episodes =&lt; 3 months prior to registration&#xD;
&#xD;
          -  Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy&#xD;
             considered investigational (utilized for a non-Food and Drug Administration&#xD;
             [FDA]-approved indication and in the context of a research investigation)&#xD;
&#xD;
          -  Immunodeficiency states including human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Active hepatitis B or C with uncontrolled disease; NOTE: a detailed assessment of&#xD;
             hepatitis B/C medical history and risk factors must be done at screening for all&#xD;
             patients; hepatitis B core immunoglobulin M antibody (HBcIgM Ab), hepatitis B surface&#xD;
             antigen (HBsAg) and hepatitis C antibody screen (HCV Ab Scrn) w/reflex testing are&#xD;
             required at screening for all patients with a positive medical history based on risk&#xD;
             factors and/or confirmation of prior hepatitis B (HBV) infection&#xD;
&#xD;
          -  Active other malignancy requiring treatment that would interfere with the assessments&#xD;
             of response of the lymphoma to protocol treatment&#xD;
&#xD;
          -  Inability to swallow or impairment of gastrointestinal function or gastrointestinal&#xD;
             disease that may significantly alter the absorption of the drugs (e.g., ulcerative&#xD;
             disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small&#xD;
             bowel resection) that would preclude use of oral medications&#xD;
&#xD;
          -  Any severe and/or uncontrolled medical conditions or other conditions that, in the&#xD;
             treating physician's opinion, could adversely impact their ability to participate in&#xD;
             the study&#xD;
&#xD;
          -  Major surgery =&lt; 4 weeks prior to registration or have not recovered from side effects&#xD;
             of such therapy&#xD;
&#xD;
          -  New York Heart Association classification III or IV&#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>Han Tun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Harvard Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</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>July 2019</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>July 18, 2019</last_update_submitted>
  <last_update_submitted_qc>July 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2019</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>Burkitt Lymphoma</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Intraocular Lymphoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
    <mesh_term>Ichthammol</mesh_term>
    <mesh_term>BB 1101</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/NCT01722305
org study id: MC1281
secondary id: NCI-2012-01948
secondary id: MC1281
secondary id: P30CA015083
nct id: NCT01722305
lead sponsor: 
collaborator: 
has dmc: No
This phase I trial studies the side effects and best dose of pomalidomide when given together
      with dexamethasone in treating patients with primary central nervous system lymphoma that has
      come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma
      that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system
      to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different
      ways to stop the growth of cancer cells, either by killing the cells, stopping them from
      dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone
      may kill more cancer cells.
PRIMARY OBJECTIVES:

      I. To establish the maximum tolerated dose (MTD) of pomalidomide in combination with
      dexamethasone in patients with relapsed/refractory primary central nervous system lymphoma
      (PCNSL) or primary vitreoretinal lymphoma (PVRL).

      SECONDARY OBJECTIVES:

      I. To evaluate the efficacy (overall response rate) and safety of pomalidomide in combination
      with dexamethasone in patients with PCNSL and PVRL lymphoma in an MTD expanded cohort.

      II. To evaluate overall survival and progression free survival.

      TERTIARY OBJECTIVES:

      I. To study the pharmacokinetics of pomalidomide in the central nervous system. II. To
      identify the predictive biomarkers for responsiveness to pomalidomide.

      OUTLINE: This is a dose-escalation study of pomalidomide.

      Patients receive pomalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15,
      and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6 months for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MTD of pomalidomide when given in combination with dexamethasone determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
time frame: 28 days
description: The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level. The grade 3+ adverse events will also be described and summarized in a similar fashion. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
measure: Incidence of adverse events, graded according to CTCAE 4.0
time frame: Up to 30 days post-treatment
description: The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
measure: Overall response rate defined as number of patients with an objective status of complete response (CR), complete response/unconfirmed (Cru), or partial response (PR) divided by total number of evaluable patients
time frame: Up to 2 years
description: Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
measure: Overall survival time
time frame: Time from registration to death due to any cause, assessed up to 2 years
description: The distribution of overall survival will be estimated using the method of Kaplan-Meier.
measure: Progression-free survival
time frame: Time from registration to progression or death due to PCNSL or PVRL lymphoma, assessed up to 2 years
description: The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
measure: Pharmacokinetics of pomalidomide in the CNS
time frame: Up to day 22 of course 1
description: Based on pomalidomide levels in blood and CSF at different time points, area under curve will be determined.
measure: Predictive biomarkers for response to pomalidomide
time frame: Up to day 21 of course 1
description: Correlation studies will be performed to identify predictive immune markers for response to pomalidomide. Immune cell counts and cytokine profile will be evaluated in blood and CSF at day 1 and day 21 of course 1. Values at each time point and changes after pomalidomide treatment will be both graphically and quantitatively summarized and explored. Wilcoxon rank sum test and Fisher's exact test will be utilized where appropriate to assess the relationships of these markers with response.
arm group label: Treatment (pomalidomide, dexamethasone)
arm group type: Experimental
description: Patients receive pomalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Dexamethasone
description: Given PO
arm group label: Treatment (pomalidomide, dexamethasone)
other name: Aacidexam
other name: Adexone
other name: Aknichthol Dexa
other name: Alba-Dex
other name: Alin
other name: Alin Depot
other name: Alin Oftalmico
other name: Amplidermis
other name: Anemul mono
other name: Auricularum
other name: Auxiloson
other name: Baycuten
other name: Baycuten N
other name: Cortidexason
other name: Cortisumman
other name: Decacort
other name: Decadrol
other name: Decadron
other name: Decalix
other name: Decameth
other name: Decasone R.p.
other name: Dectancyl
other name: Dekacort
other name: Deltafluorene
other name: Deronil
other name: Desamethasone
other name: Desameton
other name: Dexa-Mamallet
other name: Dexa-Rhinosan
other name: Dexa-Scheroson
other name: Dexa-sine
other name: Dexacortal
other name: Dexacortin
other name: Dexafarma
other name: Dexafluorene
other name: Dexalocal
other name: Dexamecortin
other name: Dexameth
other name: Dexamethasonum
other name: Dexamonozon
other name: Dexapos
other name: Dexinoral
other name: Dexone
other name: Dinormon
other name: Fluorodelta
other name: Fortecortin
other name: Gammacorten
other name: Hexadecadrol
other name: Hexadrol
other name: Lokalison-F
other name: Loverine
other name: Methylfluorprednisolone
other name: Millicorten
other name: Mymethasone
other name: Orgadrone
other name: Spersadex
other name: Visumetazone
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Optional correlative studies
arm group label: Treatment (pomalidomide, dexamethasone)
intervention type: Other
intervention name: Pharmacological Study
description: Optional correlative studies
arm group label: Treatment (pomalidomide, dexamethasone)
intervention type: Drug
intervention name: Pomalidomide
description: Given PO
arm group label: Treatment (pomalidomide, dexamethasone)
other name: 4-Aminothalidomide
other name: Actimid
other name: CC-4047
other name: Imnovid
other name: Pomalyst
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Han Tun
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burkitt Lymphoma
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Intraocular Lymphoma
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Pomalidomide
mesh term: Ichthammol
mesh term: BB 1101