<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/NCT03240211</url>
  </required_header>
  <id_info>
    <org_study_id>PTCL-002</org_study_id>
    <nct_id>NCT03240211</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL</brief_title>
  <official_title>Novel Immuno-epigenetic Based Platform for Patients With Peripheral T-cell Lymphoma (PTCL) and Cutaneous T-cell Lymphoma (CTCL): an International Phase Ib Study of Pembrolizumab Combined With Decitabine and/or Pralatrexate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</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 is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation&#xD;
      study. The primary objectives of the study in each arm is to determine the maximum tolerated&#xD;
      dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate&#xD;
      the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and&#xD;
      decitabine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The peripheral T-cell lymphomas (PTCLs) are rare subtypes of Non-Hodgkin lymphoma (NHL) with&#xD;
      unique clinicopathologic features and very unfavorable prognosis. Recently it has been&#xD;
      demonstrated that PTCLs are characterized by recurrent mutations in epigenetic operators&#xD;
      (e.g. TET2, DNMT3A, and IDH2) and escape from immune surveillance.&#xD;
&#xD;
      The safety and toxicity of these combinations will be evaluated throughout the entire study.&#xD;
      Dose allocation in Arms A and C will be based upon a continual reassessment method (CRM), and&#xD;
      combination allocation in Arm B will be conducted using a DLT-adapted partial order continual&#xD;
      reassessment method (POCRM) for dose-finding with combinations of agents.&#xD;
&#xD;
      Study Hypothesis: If pralatrexate and/or decitabine functions in an immunomodulatory fashion&#xD;
      then priming and modulating the malignant cells and the microenvironment will enhance the&#xD;
      antitumor activity of pembrolizumab in patients with PTCLs and CTCLs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>This is a multicenter, multi-arm, phase Ib, model-based dose-escalation study. There will be 3 treatment arms in this study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD)</measure>
    <time_frame>1-2 years</time_frame>
    <description>The study dose level that is recommended after the maximum target sample size of 10 participants are accrued to each arm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose Limiting Toxicity (DLT)</measure>
    <time_frame>1-2 years</time_frame>
    <description>Only DLT's that occur prior to the initiation of cycle 2 will be used to determine dose escalation/de-escalation decisions. DLT criteria are defined as any non-hematologic toxicity greater and/or equal to grade 3 except for exceptions outlined in the protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>1-2 years</time_frame>
    <description>Evaluate the efficacy, as determined by the ORR (complete + partial response) for each Arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor activity</measure>
    <time_frame>1-2 years</time_frame>
    <description>Describe the anti-tumor activity of the combinations in each Arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR, PFS, DOR</measure>
    <time_frame>1-2 years</time_frame>
    <description>Evaluate the efficacy, as determined by the overall response rate (ORR), progression free survival (PFS), and duration of response (DOR) for each Arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic markers</measure>
    <time_frame>1-2 years</time_frame>
    <description>Evaluate pharmacodynamic markers of drug effect in paired tissue biopsies (pre- and post-treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Profile</measure>
    <time_frame>1-2 years</time_frame>
    <description>Establish pharmacokinetic profile for pembrolizumab when administered with pralatrexate (Arm A), with decitabine (Arm C) and when given as a combination (Arm B) during cycle 1 only.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>PTCL</condition>
  <condition>CTCL</condition>
  <arm_group>
    <arm_group_label>Arm A: Pembrolizumab plus Pralatrexate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive pembrolizumab 200 mg IV day 1 with pralatrexate 30 mg/m2 IV day 1, 8, and 15.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Pembrolizumab plus Pralatrexate plus Decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive pembrolizumab 200 mg IV day 8 with pralatrexate 20 mg/m2 IV day 1, 8, and 15 and decitabine 10 mg/m2 from day 1 to 5 ( or day 1 to 3, depending on dose level).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: Pembrolizumab plus Decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive pembrolizumab 200 mg IV and decitabine 20 mg/m2 from day 1 to 5 (or day 1 to 3, depending on dose level).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab 200 mg IV</description>
    <arm_group_label>Arm A: Pembrolizumab plus Pralatrexate</arm_group_label>
    <arm_group_label>Arm B: Pembrolizumab plus Pralatrexate plus Decitabine</arm_group_label>
    <arm_group_label>Arm C: Pembrolizumab plus Decitabine</arm_group_label>
    <other_name>Keytruda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pralatrexate</intervention_name>
    <description>Pralatrexate 20 or 30 mg/m2 IV push</description>
    <arm_group_label>Arm A: Pembrolizumab plus Pralatrexate</arm_group_label>
    <arm_group_label>Arm B: Pembrolizumab plus Pralatrexate plus Decitabine</arm_group_label>
    <other_name>Folotyn</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Decitabine 10 mg/m2</description>
    <arm_group_label>Arm B: Pembrolizumab plus Pralatrexate plus Decitabine</arm_group_label>
    <arm_group_label>Arm C: Pembrolizumab plus Decitabine</arm_group_label>
    <other_name>Dacogen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be willing and able to provide written informed consent/assent for the trial.&#xD;
&#xD;
          2. Be ≥ 18 years of age on day of signing informed consent.&#xD;
&#xD;
          3. Have measurable disease as defined by the Lugano Criteria for PTCL and by the Global&#xD;
             Response Score for CTCL.&#xD;
&#xD;
          4. Patient must have histologically confirmed relapsed or refractory Peripheral T-cell&#xD;
             lymphoma (PTCL) or cutaneous T-cell Lymphoma (CTCL) as per WHO criteria and TNMB&#xD;
             classification and staging.&#xD;
&#xD;
          5. There is no upper limit for the number of prior therapies. Patient may have relapsed&#xD;
             after prior autologous stem cell transplant.&#xD;
&#xD;
          6. Patients who had prior treatment for their disease, as long as there is radiographic&#xD;
             evidence of refractory or relapsed disease and the patient meets all other clinical&#xD;
             and laboratory criteria for study treatment.&#xD;
&#xD;
          7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a&#xD;
             tumor lesion. Be willing to provide FNA of a tumor lesion. Newly-obtained is defined&#xD;
             as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day&#xD;
             1. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or&#xD;
             subject safety concern) may submit an archived specimen only upon agreement from the&#xD;
             Sponsor.&#xD;
&#xD;
          8. Have a performance status of 0 or 1 on the ECOG Performance Scale.&#xD;
&#xD;
          9. Demonstrate adequate organ function as defined in the protocol, all screening labs&#xD;
             should be performed within 10 days of treatment initiation.&#xD;
&#xD;
         10. Female subjects of childbearing potential should have a negative urine or serum&#xD;
             pregnancy within 72 hours prior to receiving the first dose of study medication. If&#xD;
             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test&#xD;
             will be required.&#xD;
&#xD;
         11. Female subjects of childbearing potential (Section 7.7.9.2) must be willing to use an&#xD;
             adequate method of contraception as outlined in Section 7.9.2 - Contraception for the&#xD;
             course of the study through 120 days after the last dose of study medication.&#xD;
&#xD;
         12. Male subjects of childbearing potential (Section 7.9.2) must agree to use an adequate&#xD;
             method of contraception as outlined in Section 7.9.2- Contraception, starting with the&#xD;
             first dose of study therapy through 120 days after the last dose of study therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has lack of resolution of adverse events (AE) due to previously administered&#xD;
             antineoplastic therapy to grade 1 or less according to National Cancer Institute (NCI)&#xD;
             Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.&#xD;
&#xD;
          2. Had prior therapy with PD-1 inhibitors.&#xD;
&#xD;
          3. Has a diagnosis of immunodeficiency or has been receiving any immunosuppressive&#xD;
             therapy within 7 days prior to the first dose of trial treatment. Use of steroid&#xD;
             equivalent to prednisone 10 mg/day does not constitute an exclusion criterion.&#xD;
&#xD;
          4. Has a known history of active TB (Bacillus Tuberculosis)&#xD;
&#xD;
          5. Hypersensitivity to pralatrexate, or decitabine or pembrolizumab or any of its&#xD;
             excipients.&#xD;
&#xD;
          6. Has received prior allogeneic stem cell transplant.&#xD;
&#xD;
          7. Has a known additional malignancy that is progressing or requires active treatment.&#xD;
             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
             skin that has undergone potentially curative therapy or in situ cervical cancer.&#xD;
&#xD;
          8. Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis. Subjects with previously treated brain metastases may participate provided&#xD;
             they are stable (without evidence of progression by imaging for at least four weeks&#xD;
             prior to the first dose of trial treatment and any neurologic symptoms have returned&#xD;
             to baseline), have no evidence of new or enlarging brain metastases, and are not using&#xD;
             steroids for at least 7 days prior to trial treatment. This exception does not include&#xD;
             carcinomatous meningitis which is excluded regardless of clinical stability.&#xD;
&#xD;
          9. Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment. The following are exceptions to this criterion: subjects&#xD;
             with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto&#xD;
             syndrome) stable on hormone replacement; subjects with psoriasis not requiring&#xD;
             systemic treatment; patients with autoimmune phenomena secondary to active lymphoma.&#xD;
&#xD;
         10. Has known history of, or any evidence of non-infectious pneumonitis/interstitial lung&#xD;
             disease that required steroids or has current pneumonitis/interstitial lung disease.&#xD;
&#xD;
         11. Has an active infection requiring systemic therapy.&#xD;
&#xD;
         12. Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the trial, interfere with the subject's&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the treating investigator.&#xD;
&#xD;
         13. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
         14. Is pregnant or breastfeeding or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment.&#xD;
&#xD;
         15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.&#xD;
&#xD;
         16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
         17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA&#xD;
             [qualitative] is detected).&#xD;
&#xD;
         18. Has received a live vaccine or live-attenuated vaccine within 30 days of planned start&#xD;
             of study therapy. Administration of killed vaccines is allowed.&#xD;
&#xD;
        Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and&#xD;
        are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated&#xD;
        vaccines, and are not allowed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Owen O'Connor, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Enrica Marchi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marian Abdelmalek, MSc</last_name>
    <phone>434-924-8827</phone>
    <email>mka6s@virginia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Justin Alicea</last_name>
    <phone>434-243-5350</phone>
    <email>xzy7tw@virginia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Allegheny Health Network</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212-4722</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Lister, MD</last_name>
      <phone>412-578-4355</phone>
      <email>john.lister@ahn.org</email>
    </contact>
    <contact_backup>
      <last_name>Diane Pershing, RN</last_name>
      <phone>412-578-5987</phone>
      <email>diane.pershing@ahn.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marian Abdelmalek, MS</last_name>
      <phone>434-924-8827</phone>
      <email>mka6s@hscmail.mcc.virginia.edu</email>
    </contact>
    <investigator>
      <last_name>Enrica Marchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Craig Portell, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
    <country>Korea, Republic of</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Enrica Marchi, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Pembrolizumab</keyword>
  <keyword>Decitabine</keyword>
  <keyword>Pralatrexate</keyword>
  <keyword>T-cell lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, T-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Decitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03240211
org study id: PTCL-002
nct id: NCT03240211
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation
      study. The primary objectives of the study in each arm is to determine the maximum tolerated
      dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate
      the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and
      decitabine.
The peripheral T-cell lymphomas (PTCLs) are rare subtypes of Non-Hodgkin lymphoma (NHL) with
      unique clinicopathologic features and very unfavorable prognosis. Recently it has been
      demonstrated that PTCLs are characterized by recurrent mutations in epigenetic operators
      (e.g. TET2, DNMT3A, and IDH2) and escape from immune surveillance.

      The safety and toxicity of these combinations will be evaluated throughout the entire study.
      Dose allocation in Arms A and C will be based upon a continual reassessment method (CRM), and
      combination allocation in Arm B will be conducted using a DLT-adapted partial order continual
      reassessment method (POCRM) for dose-finding with combinations of agents.

      Study Hypothesis: If pralatrexate and/or decitabine functions in an immunomodulatory fashion
      then priming and modulating the malignant cells and the microenvironment will enhance the
      antitumor activity of pembrolizumab in patients with PTCLs and CTCLs.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a multicenter, multi-arm, phase Ib, model-based dose-escalation study. There will be 3 treatment arms in this study.
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD)
time frame: 1-2 years
description: The study dose level that is recommended after the maximum target sample size of 10 participants are accrued to each arm
measure: Dose Limiting Toxicity (DLT)
time frame: 1-2 years
description: Only DLT's that occur prior to the initiation of cycle 2 will be used to determine dose escalation/de-escalation decisions. DLT criteria are defined as any non-hematologic toxicity greater and/or equal to grade 3 except for exceptions outlined in the protocol.
measure: Overall Response Rate (ORR)
time frame: 1-2 years
description: Evaluate the efficacy, as determined by the ORR (complete + partial response) for each Arm
measure: Anti-tumor activity
time frame: 1-2 years
description: Describe the anti-tumor activity of the combinations in each Arm.
measure: ORR, PFS, DOR
time frame: 1-2 years
description: Evaluate the efficacy, as determined by the overall response rate (ORR), progression free survival (PFS), and duration of response (DOR) for each Arm.
measure: Pharmacodynamic markers
time frame: 1-2 years
description: Evaluate pharmacodynamic markers of drug effect in paired tissue biopsies (pre- and post-treatment).
measure: Pharmacokinetic Profile
time frame: 1-2 years
description: Establish pharmacokinetic profile for pembrolizumab when administered with pralatrexate (Arm A), with decitabine (Arm C) and when given as a combination (Arm B) during cycle 1 only.
arm group label: Arm A: Pembrolizumab plus Pralatrexate
arm group type: Experimental
description: Subjects will receive pembrolizumab 200 mg IV day 1 with pralatrexate 30 mg/m2 IV day 1, 8, and 15.
arm group label: Arm B: Pembrolizumab plus Pralatrexate plus Decitabine
arm group type: Experimental
description: Subjects will receive pembrolizumab 200 mg IV day 8 with pralatrexate 20 mg/m2 IV day 1, 8, and 15 and decitabine 10 mg/m2 from day 1 to 5 ( or day 1 to 3, depending on dose level).
arm group label: Arm C: Pembrolizumab plus Decitabine
arm group type: Experimental
description: Subjects will receive pembrolizumab 200 mg IV and decitabine 20 mg/m2 from day 1 to 5 (or day 1 to 3, depending on dose level).
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab 200 mg IV
arm group label: Arm A: Pembrolizumab plus Pralatrexate
arm group label: Arm B: Pembrolizumab plus Pralatrexate plus Decitabine
arm group label: Arm C: Pembrolizumab plus Decitabine
other name: Keytruda
intervention type: Drug
intervention name: Pralatrexate
description: Pralatrexate 20 or 30 mg/m2 IV push
arm group label: Arm A: Pembrolizumab plus Pralatrexate
arm group label: Arm B: Pembrolizumab plus Pralatrexate plus Decitabine
other name: Folotyn
intervention type: Drug
intervention name: Decitabine
description: Decitabine 10 mg/m2
arm group label: Arm B: Pembrolizumab plus Pralatrexate plus Decitabine
arm group label: Arm C: Pembrolizumab plus Decitabine
other name: Dacogen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Owen O'Connor, MD, PhD
role: Study Chair
affiliation: University of Virginia
last name: Enrica Marchi, MD, PhD
role: Principal Investigator
affiliation: University of Virginia
last name: Marian Abdelmalek, MSc
phone: 434-924-8827
email: mka6s@virginia.edu
last name: Justin Alicea
phone: 434-243-5350
email: xzy7tw@virginia.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
country: Italy
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Enrica Marchi, MD
investigator title: Professor of Medicine
mesh term: Lymphoma, T-Cell
mesh term: Pembrolizumab
mesh term: Decitabine
sharing ipd: No