xml: <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/NCT06035497</url>
    </required_header>
    <id_info>
      <org_study_id>CA073-1008</org_study_id>
      <nct_id>NCT06035497</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan</brief_title>
    <official_title>A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 in Participants With Relapsed or Refractory T-cell Lymphomas in Japan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bristol-Myers Squibb</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of&#xD;
        BMS-986369 in participants with relapsed or refractory T-cell lymphomas in Japan.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2030</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2027</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>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with Adverse Events (AEs)</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with Dose-Limiting Toxicity (DLT)</measure>
      <time_frame>Up to 28 days after first dose</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with laboratory abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with Electrocardiogram (ECG) abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Eastern Cooperative Oncology Group Performance Status (ECOG PS)</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with Physical Examination (PE) abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 1 participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 2 years after last does of treatment</time_frame>
      <description>Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort&#xD;
  OR is defined as the achievement of Partial Response (PR) or Complete Response (CR)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)</measure>
      <time_frame>Up to 2 years after last dose of treatment</time_frame>
      <description>Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort&#xD;
  OR is defined as the achievement of PR or CR</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum observed plasma concentration (Cmax)</measure>
      <time_frame>Up to Day 8 of Cycle 2 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration time-curve (AUC)</measure>
      <time_frame>Up to Day 8 of Cycle 2 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to peak (maximum) plasma concentration (Tmax)</measure>
      <time_frame>Up to Day 8 of Cycle 2 (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with AEs</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with TEAEs</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with laboratory abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with vital sign abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with ECG abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ECOG PS</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with LVEF assessment abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with PE abnormalities</measure>
      <time_frame>Up to 5 weeks after last dose of treatment</time_frame>
      <description>Phase 2 participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants&#xD;
  OR is defined as the achievement of PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants&#xD;
  OR is defined as the achievement of PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants&#xD;
  OR is defined as the achievement of PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants&#xD;
  OR is defined as the achievement of PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants&#xD;
  Disease control is considered to be stable disease (SD), PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants&#xD;
  Disease control is considered to be SD, PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR) as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TTR as assessed by investigator per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL Participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR as assessed by investigator per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL Participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS as assessed by investigator per international consensus response criteria for ATL</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>ATL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants&#xD;
  Disease control is considered to be SD, PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants&#xD;
  Disease control is considered to be SD, PR or CR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)</measure>
      <time_frame>Up to 4 years after last dose of treatment</time_frame>
      <description>PTCL participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to next treatment (TTNT)</measure>
      <time_frame>From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, time to next treatment or the end of the trial, whichever occurs first, assessed up to 4 years.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, or the end of the trial, whichever occurs first, assessed up to 4 years.</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Relapsed or Refractory T-cell Lymphomas</condition>
    <arm_group>
      <arm_group_label>Administration of BMS-986369</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986369</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Administration of BMS-986369</arm_group_label>
      <other_name>Golcadomide</other_name>
      <other_name>CC-99282</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have T-cell Lymphoma with relapsed or refractory disease, as assessed by the&#xD;
               investigator&#xD;
  &#xD;
            -  Phase 1 participants must not be responsive, intolerant, or ineligible to standard&#xD;
               therapies that may prolong life or provide symptomatic relief, or for whom no standard&#xD;
               therapeutic option is available in the clinical practice guidelines in the opinion of&#xD;
               the investigator.&#xD;
  &#xD;
            -  Phase 2 participants must have been treated by at least 1 prior line of systemic&#xD;
               therapy.&#xD;
  &#xD;
            -  Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have any significant medical condition, laboratory abnormality, or psychiatric illness&#xD;
               that would prevent the participants from participating in the study.&#xD;
  &#xD;
            -  Have any condition, including active or uncontrolled infection, or the presence of&#xD;
               laboratory abnormalities, which places the participants at unacceptable risk if he/she&#xD;
               were to participate in the study.&#xD;
  &#xD;
            -  Have a life expectancy ≤ 3 months.&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria apply&#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>Bistol-Myers Squibb</last_name>
      <role>Study Director</role>
      <affiliation>Bristol-Myers Squibb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BMS Study Connect www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site#</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Local Institution - 0001</name>
        <address>
          <city>Sendai-shi</city>
          <state>Miyagi</state>
          <zip>980-8574</zip>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0001</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>BMS Clinical Trial Information</description>
    </link>
    <link>
      <url>http://www.BMSStudyConnect.com</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Relapsed or Refractory Peripheral T-cell Lymphoma</keyword>
    <keyword>Relapsed or Refractory Adult T-cell Leukemia/Lymphoma</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>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035497
  org study id: CA073-1008
  nct id: NCT06035497
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of
        BMS-986369 in participants with relapsed or refractory T-cell lymphomas in Japan.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with Adverse Events (AEs)
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants with treatment-emergent adverse events (TEAEs)
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants with Dose-Limiting Toxicity (DLT)
  time frame: Up to 28 days after first dose
  description: Phase 1 participants
  measure: Number of participants with laboratory abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants with vital sign abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants with Electrocardiogram (ECG) abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants with Physical Examination (PE) abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 1 participants
  measure: Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 2 years after last does of treatment
  description: Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort
  OR is defined as the achievement of Partial Response (PR) or Complete Response (CR)
  measure: Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
  time frame: Up to 2 years after last dose of treatment
  description: Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort
  OR is defined as the achievement of PR or CR
  measure: Maximum observed plasma concentration (Cmax)
  time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
  measure: Area under the plasma concentration time-curve (AUC)
  time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
  measure: Time to peak (maximum) plasma concentration (Tmax)
  time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
  measure: Number of participants with AEs
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants with TEAEs
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants with laboratory abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants with vital sign abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants with ECG abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: ECOG PS
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants with LVEF assessment abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants with PE abnormalities
  time frame: Up to 5 weeks after last dose of treatment
  description: Phase 2 participants
  measure: Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  OR is defined as the achievement of PR or CR
  measure: Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  OR is defined as the achievement of PR or CR
  measure: Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based).
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  OR is defined as the achievement of PR or CR
  measure: Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based).
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  OR is defined as the achievement of PR or CR
  measure: Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  Disease control is considered to be stable disease (SD), PR or CR
  measure: Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  Disease control is considered to be SD, PR or CR
  measure: Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  measure: Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  measure: Time to response (TTR) as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  measure: TTR as assessed by investigator per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  measure: Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL Participants
  measure: DOR as assessed by investigator per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL Participants
  measure: Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  measure: PFS as assessed by investigator per international consensus response criteria for ATL
  time frame: Up to 4 years after last dose of treatment
  description: ATL participants
  measure: Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  Disease control is considered to be SD, PR or CR
  measure: Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  Disease control is considered to be SD, PR or CR
  measure: Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based)
  time frame: Up to 4 years after last dose of treatment
  description: PTCL participants
  measure: Time to next treatment (TTNT)
  time frame: From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, time to next treatment or the end of the trial, whichever occurs first, assessed up to 4 years.
  measure: Overall survival (OS)
  time frame: From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, or the end of the trial, whichever occurs first, assessed up to 4 years.
  arm group label: Administration of BMS-986369
  arm group type: Experimental
  intervention type: Drug
  intervention name: BMS-986369
  description: Specified dose on specified days
  arm group label: Administration of BMS-986369
  other name: Golcadomide
  other name: CC-99282
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bistol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site#
  facility: 
  contact: 
  country: Japan
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: http://www.BMSStudyConnect.com
  description: BMS Clinical Trial Patient Recruiting
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, T-Cell
  mesh term: Lymphoma, T-Cell, Peripheral