<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/NCT03246750</url>
  </required_header>
  <id_info>
    <org_study_id>TLSG-2017-T01</org_study_id>
    <nct_id>NCT03246750</nct_id>
  </id_info>
  <brief_title>B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma</brief_title>
  <official_title>Phase I/II Study of Brentuximab Vedotin and Methotrexate/ L-asparaginase/ Dexamethasone (B-MAD) Chemotherapy in Patients With Newly-diagnosed Extranodal NK/ T-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Thai Lymphoma Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Thai Lymphoma Study Group</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/&#xD;
      dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell&#xD;
      Lymphoma&#xD;
&#xD;
      Phase: I/II&#xD;
&#xD;
      Number of Patients: 36&#xD;
&#xD;
      Study Objectives&#xD;
&#xD;
      Primary&#xD;
&#xD;
        -  To determine the safety and optimal dose of brentuximab vedotin when use in combination&#xD;
           with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed&#xD;
           ENKTL patients&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        -  To evaluate the clinical efficacy of this regimen&#xD;
&#xD;
        -  To access the overall responses including overall response rate (ORR), disease-free&#xD;
           survival (DSF), progression-free survival (PFS).&#xD;
&#xD;
      Overview of Study Design:&#xD;
&#xD;
      Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in&#xD;
      combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the&#xD;
      determination of the recommended phase II dose.&#xD;
&#xD;
      Patients will be received the treatment according to the stage of disease as follows:&#xD;
&#xD;
        -  Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field&#xD;
           radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks&#xD;
           after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate,&#xD;
           L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles.&#xD;
&#xD;
        -  Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for&#xD;
           6 cycles.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      Patients with newly-diagnosed ENKTL will be screened for enrollment.&#xD;
&#xD;
      Duration of Study: 3 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/&#xD;
      dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell&#xD;
      Lymphoma&#xD;
&#xD;
      Phase: I/II&#xD;
&#xD;
      Number of Patients: 36&#xD;
&#xD;
      Study Objectives&#xD;
&#xD;
      Primary&#xD;
&#xD;
        -  To determine the safety and optimal dose of brentuximab vedotin when use in combination&#xD;
           with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed&#xD;
           ENKTL patients&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        -  To evaluate the clinical efficacy of this regimen&#xD;
&#xD;
        -  To access the overall responses including overall response rate (ORR), disease-free&#xD;
           survival (DSF), progression-free survival (PFS).&#xD;
&#xD;
      Overview of Study Design:&#xD;
&#xD;
      Open-label, multicenter, non-randomized, 3+3 dose escalation study, starting with 1.2 mg/kg&#xD;
      brentuximab vedotin i.v. on day 1 of a 21-day cycle in combination with fixed-dose MAD&#xD;
      (Methotrexate, L-asparaginase and Dexamethasone) chemotherapy. The first cycle will be&#xD;
      evaluated for the determination of the recommended phase II dose.&#xD;
&#xD;
      Patients will be received the treatment according to the stage of disease as follows:&#xD;
&#xD;
        -  Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field&#xD;
           radiation (IRFT) 40-50 Gy with concomitant weekly intravenous Cisplatin. Three to five&#xD;
           weeks after the completion of IFRT and cisplatin, B-MAD chemotherapy will be given every&#xD;
           21 days for 3 cycles.&#xD;
&#xD;
        -  Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for&#xD;
           6 cycles.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      Patients with newly-diagnosed ENKTL will be screened for enrollment.&#xD;
&#xD;
      Duration of Study: 3 years&#xD;
&#xD;
      Determination of Sample Size&#xD;
&#xD;
      ENKTL is a rare and highly aggressive disease. Due to the rarity, most published studies&#xD;
      evaluating new treatment regimen for ENKTL enrolled approximately 20-40 patients in their&#xD;
      studies. Since the phase I of this study is designed as 3+3 dose escalation, then this study&#xD;
      will enroll approximately 3-12 patients with localized stage in phase I for dose finding. The&#xD;
      beginning dose of brentuximab vedotin will be 1.2 mg/kg, escalating gradually until dose&#xD;
      limiting toxicity (DLT) is observed. Initially, 3 patients will be treated with 1.2 mg/kg of&#xD;
      brentuximab vedotin and will be monitored for DLT. If there is no DLT observed in all 3&#xD;
      patients at the end of their first treatment cycle, dose escalation to the next dose level&#xD;
      (1.8mg/kg) may commence. If there is a DLT observed in 1 of the first 3 patients, additional&#xD;
      3 patients will be included, expanding the cohort to 6 patients. This cohort of patients will&#xD;
      be treated with the same previous dose of 1.2 mg/kg and monitor for DLTs. If no DLT observed,&#xD;
      dose escalation to the next level (1.8 mg/kg) may commence. If there are DLTs observed in 2&#xD;
      or higher in any of the 6 patients prior dose (0.8mg/kg) will be defined as MTD. There will&#xD;
      be no further additional patient inclusion and dose escalation beyond the maximum number of&#xD;
      12 patients and 1.8mg/kg, as MTD will be exceeded.&#xD;
&#xD;
      For phase II study, after reviewed the number of ENKTL patients in the Thai Lymphoma Study&#xD;
      Group Registry, there were 106 newly diagnosed ENKTL patients in the registry from 2007-2013.&#xD;
      This translated to approximately 15 newly diagnosed ENKTL patients per year. Since this study&#xD;
      has the time for patient accruement of three years and with respect to the reference from&#xD;
      other previous studies, the total approximate patients in this study for phase I and II is&#xD;
      36.&#xD;
&#xD;
      Populations for Analyses&#xD;
&#xD;
      The full analysis set (FAS) comprises of all patients who were enrolled into the study.&#xD;
&#xD;
      The per-protocol analysis (PAS) set comprises of all patient in the FAS who completed cycles&#xD;
      of B-MAD.&#xD;
&#xD;
      The dose-determining set (DDS) comprises of all patients in the SAS who had at least one&#xD;
      valid safety assessment after completion of the first cycle of B-MAD or discontinue earlier&#xD;
      due to DLT.&#xD;
&#xD;
      Demographic and Baseline Characteristics&#xD;
&#xD;
      Demographic and baseline characteristics will be listed individually by patient, and&#xD;
      summarized by cohort using descriptive statistic. The FAS will be used.&#xD;
&#xD;
      Efficacy Analysis&#xD;
&#xD;
      The efficacy analysis set (EAS) comprises of all patients who are able to evaluate for&#xD;
      efficacy at least once post-baseline.&#xD;
&#xD;
      Safety Analysis&#xD;
&#xD;
      The safety analysis set (SAS) comprises of all patients of the FAS who received at least one&#xD;
      dose of B-MAD and had at least one valid post-baseline safety assessment. (The statement that&#xD;
      a patient had no adverse events on the CRF confirms a valid safety assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>Phase 1/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>
    <intervention_model_description>3+3 dose escaltion design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>At the end of Cycle 1 (each cycle is 21 days)</time_frame>
    <description>Patients will be assessed for dose-limiting toxicity (DLT) during the first cycle.&#xD;
DLTs are described as follows:&#xD;
For non-hematologic toxicities&#xD;
• Any related non-hematologic events of grade 3 or higher, with the exception of:&#xD;
grade 3 fatigue&#xD;
grade 3 or 4 nausea and vomiting lasting than 24 hours&#xD;
grade 3 non-hematologic laboratory abnormalities resolving to grade 1 or baseline within 14 days&#xD;
grade 3 or 4 allergic or hypersensitivity reaction&#xD;
For hematologic toxicities&#xD;
Related grade 4 neutropenia lasting &gt; 7 days&#xD;
Related grade 3 febrile neutropenia requiring antibiotics&#xD;
Related grade 4 febrile neutropenia&#xD;
Related grade 4 thrombocytopenia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment responses</measure>
    <time_frame>At 7th week after last BV dosing</time_frame>
    <description>The treatment response will be evaluated according to the 2014 Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma - The Lugano Classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Time from complete remission to relapse or death as a result of lymphoma or acute toxicity of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>Time from entry on to study to disease progression or death as a result of any cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Extranodal NK/T-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>B-MAD chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brentuximab Vedotin, Methotrexate, L-Asparaginase, and Dexamethasone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>B-MAD chemotherapy</intervention_name>
    <description>B-MAD chemotherapy</description>
    <arm_group_label>B-MAD chemotherapy</arm_group_label>
    <other_name>Involved field radation, cisplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with previously untreated ENKTL as defined by the World Health Organization&#xD;
             (WHO) classification&#xD;
&#xD;
          -  Age 18-60 years&#xD;
&#xD;
          -  Localized (stage I, II) or advanced (stage III, IV) disease&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other subtypes of non-Hodgkin lymphoma, including myeloid/NK cell&#xD;
             precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic&#xD;
             leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified&#xD;
&#xD;
          -  Prior chemotherapy or radiotherapy for ENKTL&#xD;
&#xD;
          -  Seropositivity for HIV and severe infection&#xD;
&#xD;
          -  Prior or other concomitant malignant tumors&#xD;
&#xD;
          -  Pregnant or breastfeeding patients&#xD;
&#xD;
          -  Evidence of any other disease or medical conditions that contraindicate use of the&#xD;
             study drug, or patients at high risk from treatment complications&#xD;
&#xD;
          -  Patients suffering from psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Udomsak Bunworasate, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>May 20, 2023</last_update_submitted>
  <last_update_submitted_qc>May 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Thai Lymphoma Study Group</investigator_affiliation>
    <investigator_full_name>Asst.Prof.Udomsak Bunworasate</investigator_full_name>
    <investigator_title>A.Prof.</investigator_title>
  </responsible_party>
  <keyword>Brentuximab Vedotin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</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/NCT03246750
org study id: TLSG-2017-T01
nct id: NCT03246750
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/
      dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell
      Lymphoma

      Phase: I/II

      Number of Patients: 36

      Study Objectives

      Primary

        -  To determine the safety and optimal dose of brentuximab vedotin when use in combination
           with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed
           ENKTL patients

      Secondary

        -  To evaluate the clinical efficacy of this regimen

        -  To access the overall responses including overall response rate (ORR), disease-free
           survival (DSF), progression-free survival (PFS).

      Overview of Study Design:

      Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in
      combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the
      determination of the recommended phase II dose.

      Patients will be received the treatment according to the stage of disease as follows:

        -  Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field
           radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks
           after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate,
           L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles.

        -  Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for
           6 cycles.

      Study Population:

      Patients with newly-diagnosed ENKTL will be screened for enrollment.

      Duration of Study: 3 years
Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/
      dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell
      Lymphoma

      Phase: I/II

      Number of Patients: 36

      Study Objectives

      Primary

        -  To determine the safety and optimal dose of brentuximab vedotin when use in combination
           with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed
           ENKTL patients

      Secondary

        -  To evaluate the clinical efficacy of this regimen

        -  To access the overall responses including overall response rate (ORR), disease-free
           survival (DSF), progression-free survival (PFS).

      Overview of Study Design:

      Open-label, multicenter, non-randomized, 3+3 dose escalation study, starting with 1.2 mg/kg
      brentuximab vedotin i.v. on day 1 of a 21-day cycle in combination with fixed-dose MAD
      (Methotrexate, L-asparaginase and Dexamethasone) chemotherapy. The first cycle will be
      evaluated for the determination of the recommended phase II dose.

      Patients will be received the treatment according to the stage of disease as follows:

        -  Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field
           radiation (IRFT) 40-50 Gy with concomitant weekly intravenous Cisplatin. Three to five
           weeks after the completion of IFRT and cisplatin, B-MAD chemotherapy will be given every
           21 days for 3 cycles.

        -  Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for
           6 cycles.

      Study Population:

      Patients with newly-diagnosed ENKTL will be screened for enrollment.

      Duration of Study: 3 years

      Determination of Sample Size

      ENKTL is a rare and highly aggressive disease. Due to the rarity, most published studies
      evaluating new treatment regimen for ENKTL enrolled approximately 20-40 patients in their
      studies. Since the phase I of this study is designed as 3+3 dose escalation, then this study
      will enroll approximately 3-12 patients with localized stage in phase I for dose finding. The
      beginning dose of brentuximab vedotin will be 1.2 mg/kg, escalating gradually until dose
      limiting toxicity (DLT) is observed. Initially, 3 patients will be treated with 1.2 mg/kg of
      brentuximab vedotin and will be monitored for DLT. If there is no DLT observed in all 3
      patients at the end of their first treatment cycle, dose escalation to the next dose level
      (1.8mg/kg) may commence. If there is a DLT observed in 1 of the first 3 patients, additional
      3 patients will be included, expanding the cohort to 6 patients. This cohort of patients will
      be treated with the same previous dose of 1.2 mg/kg and monitor for DLTs. If no DLT observed,
      dose escalation to the next level (1.8 mg/kg) may commence. If there are DLTs observed in 2
      or higher in any of the 6 patients prior dose (0.8mg/kg) will be defined as MTD. There will
      be no further additional patient inclusion and dose escalation beyond the maximum number of
      12 patients and 1.8mg/kg, as MTD will be exceeded.

      For phase II study, after reviewed the number of ENKTL patients in the Thai Lymphoma Study
      Group Registry, there were 106 newly diagnosed ENKTL patients in the registry from 2007-2013.
      This translated to approximately 15 newly diagnosed ENKTL patients per year. Since this study
      has the time for patient accruement of three years and with respect to the reference from
      other previous studies, the total approximate patients in this study for phase I and II is
      36.

      Populations for Analyses

      The full analysis set (FAS) comprises of all patients who were enrolled into the study.

      The per-protocol analysis (PAS) set comprises of all patient in the FAS who completed cycles
      of B-MAD.

      The dose-determining set (DDS) comprises of all patients in the SAS who had at least one
      valid safety assessment after completion of the first cycle of B-MAD or discontinue earlier
      due to DLT.

      Demographic and Baseline Characteristics

      Demographic and baseline characteristics will be listed individually by patient, and
      summarized by cohort using descriptive statistic. The FAS will be used.

      Efficacy Analysis

      The efficacy analysis set (EAS) comprises of all patients who are able to evaluate for
      efficacy at least once post-baseline.

      Safety Analysis

      The safety analysis set (SAS) comprises of all patients of the FAS who received at least one
      dose of B-MAD and had at least one valid post-baseline safety assessment. (The statement that
      a patient had no adverse events on the CRF confirms a valid safety assessment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 3+3 dose escaltion design
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: At the end of Cycle 1 (each cycle is 21 days)
description: Patients will be assessed for dose-limiting toxicity (DLT) during the first cycle.
DLTs are described as follows:
For non-hematologic toxicities
• Any related non-hematologic events of grade 3 or higher, with the exception of:
grade 3 fatigue
grade 3 or 4 nausea and vomiting lasting than 24 hours
grade 3 non-hematologic laboratory abnormalities resolving to grade 1 or baseline within 14 days
grade 3 or 4 allergic or hypersensitivity reaction
For hematologic toxicities
Related grade 4 neutropenia lasting > 7 days
Related grade 3 febrile neutropenia requiring antibiotics
Related grade 4 febrile neutropenia
Related grade 4 thrombocytopenia
measure: Treatment responses
time frame: At 7th week after last BV dosing
description: The treatment response will be evaluated according to the 2014 Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma - The Lugano Classification.
measure: Disease-free survival
time frame: 1 year
description: Time from complete remission to relapse or death as a result of lymphoma or acute toxicity of treatment
measure: Progression-free survival
time frame: 1 year
description: Time from entry on to study to disease progression or death as a result of any cause
arm group label: B-MAD chemotherapy
arm group type: Experimental
description: Brentuximab Vedotin, Methotrexate, L-Asparaginase, and Dexamethasone
intervention type: Drug
intervention name: B-MAD chemotherapy
description: B-MAD chemotherapy
arm group label: B-MAD chemotherapy
other name: Involved field radation, cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Udomsak Bunworasate, MD
role: Principal Investigator
affiliation: Chulalongkorn University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: The Thai Lymphoma Study Group
investigator full name: Asst.Prof.Udomsak Bunworasate
investigator title: A.Prof.
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Extranodal NK-T-Cell
mesh term: Cisplatin
sharing ipd: No