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/NCT05963347</url>
    </required_header>
    <id_info>
      <org_study_id>DZ2022J0003</org_study_id>
      <nct_id>NCT05963347</nct_id>
    </id_info>
    <brief_title>Go-CHOP as the Frontline Therapy for PTCL</brief_title>
    <official_title>A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Henan Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Henan Cancer Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of&#xD;
        golidocitinib in Combination with CHOP as the front-line Treatment for Participants with&#xD;
        Peripheral T-cell Lymphomas (PTCL).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 3, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
      <time_frame>From first dose till 28 days post the last dose</time_frame>
      <description>TEAE, lab test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complete Response Rate</measure>
      <time_frame>From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)</time_frame>
      <description>Complete response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate</measure>
      <time_frame>From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)</time_frame>
      <description>Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival</measure>
      <time_frame>From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year)</time_frame>
      <description>Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response</measure>
      <time_frame>from first documented response till disease progression or death of any reason (up to 2 years)</time_frame>
      <description>Duration of response assessed by investigator per Lugano 2014 criteria</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Peripheral T Cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>Go-CHOP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Golidocitinib in combination with CHOP</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Golidocitinib</intervention_name>
      <description>Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib.</description>
      <arm_group_label>Go-CHOP</arm_group_label>
      <other_name>AZD4205, DZD4205</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CHOP Regimen</intervention_name>
      <description>CHOP will be administered in a 21-day cycle for a maximum of 6 cycles.</description>
      <arm_group_label>Go-CHOP</arm_group_label>
      <other_name>Cyclophosphamide, doxorubicin, vincristine, prednisone</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants must sign an informed consent form prior to trial-specific procedures,&#xD;
               sampling, and analysis.&#xD;
  &#xD;
            2. Participants must be at least 18 years of age (inclusive) at the time of signing the&#xD;
               informed consent form.&#xD;
  &#xD;
            3. The participant has an ECOG performance status of 0 to 2 and has not deteriorated in&#xD;
               the past 2 weeks.&#xD;
  &#xD;
            4. Life expectancy ≥ 3 months.&#xD;
  &#xD;
            5. Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphoma&#xD;
               therapy; and assessed by a local pathologist according to the 2016 revised World&#xD;
               Health Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) as&#xD;
               the following subtypes:&#xD;
  &#xD;
                 -  peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)&#xD;
  &#xD;
                 -  angioimmunoblastic T cell lymphoma (AITL)&#xD;
  &#xD;
                 -  follicular T-cell lymphoma (FTCL)&#xD;
  &#xD;
                 -  nodular PTCL with follicular helper T-cell phenotype (nodular PTCL with TFH&#xD;
                    phenotype)&#xD;
  &#xD;
                 -  ALK- anaplastic large cell lymphoma (ALK- ALCL)&#xD;
  &#xD;
                 -  ALK+ anaplastic large cell lymphoma (ALK + ALCL)&#xD;
  &#xD;
                 -  enteropathy-associated T-cell lymphoma (EATL)&#xD;
  &#xD;
                 -  monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)&#xD;
  &#xD;
                 -  hepatosplenic T-cell lymphoma (HSTCL)&#xD;
  &#xD;
                 -  subcutaneous panniculitis-like T-cell lymphoma (SPTCL)&#xD;
  &#xD;
            6. Adequate bone marrow reserve and organ system function reserve&#xD;
  &#xD;
            7. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by ECHO.&#xD;
  &#xD;
            8. Participants should be able and willing to comply with the study protocol requirement.&#xD;
  &#xD;
            9. Adequate birth control measures should be taken during study treatment and the&#xD;
               corresponding washout period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Received any of the following interventions:&#xD;
  &#xD;
                 -  Prior therapy for PTCL prior to enrollment, except short-term corticosteroids&#xD;
                    (duration ≤ 7 days, equivalent prednisone dose ≤ 15 mg/day).&#xD;
  &#xD;
                 -  Prior radiation therapy for PTCL except local therapy for individual areas.&#xD;
  &#xD;
                 -  Currently receiving other systemic antineoplastic or investigational therapy.&#xD;
  &#xD;
                 -  Participants who have received more than 200 mg/m2 doxorubicin or other&#xD;
                    equivalent doses of anthracycline/anthraquinone (e.g., epirubicin, daunorubicin,&#xD;
                    mitoxantrone, etc.) cumulatively.&#xD;
  &#xD;
                 -  Major surgical procedures (excluding routine lymphoma care programs such as&#xD;
                    vascular access placement, biopsy, etc.) or significant trauma within 4 weeks&#xD;
                    prior to the first dose of study treatment, or anticipation of the need for major&#xD;
                    surgery during the study.&#xD;
  &#xD;
                 -  Prior treatment with JAK or STAT3 inhibitors following diagnosis of PTCL.&#xD;
  &#xD;
                 -  Live vaccine within 28 days prior to enrollment.&#xD;
  &#xD;
                 -  Participants currently receiving (or unable to discontinue for at least 1 week&#xD;
                    prior to first dose) vitamin K antagonists, antiplatelets, or anticoagulants.&#xD;
  &#xD;
                 -  Participants currently receiving (or unable to discontinue for at least 1 week&#xD;
                    prior to receiving the first dose) medications or herbal supplements known to be&#xD;
                    highly potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or&#xD;
                    P-gp with a narrow therapeutic index (see Section 6.8).&#xD;
  &#xD;
            2. Participants with clinical manifestations or imaging findings suggesting central&#xD;
               nervous system or leptomeningeal lymphoma.&#xD;
  &#xD;
            3. Participants with severe lung dysfunction, pneumonitis, drug-induced interstitial lung&#xD;
               disease, radiation pneumonitis requiring steroid therapy, or any prior history of&#xD;
               clinically active interstitial lung disease.&#xD;
  &#xD;
            4. Participants with a condition that requires treatment with immunosuppressants,&#xD;
               biologics, or nonsteroidal anti-inflammatory drugs (NSAIDs).&#xD;
  &#xD;
            5. Participants with active infections&#xD;
  &#xD;
            6. Participants with significant cardiac disorder&#xD;
  &#xD;
            7. Other malignancies within 3 years before enrollment. However, malignancies, such as&#xD;
               uterine and cervical carcinoma in situ, basal or squamous cell carcinoma, and&#xD;
               non-melanotic skin cancer, which have been clinically cured after evaluation, may be&#xD;
               considered for inclusion after evaluation.&#xD;
  &#xD;
            8. Refractory nausea or vomiting that cannot be controlled by supportive therapy, chronic&#xD;
               gastrointestinal disease, inability to swallow pharmaceutical agents or previous major&#xD;
               bowel resection may affect the adequate absorption of golidocitinib.&#xD;
  &#xD;
            9. Female participants who are lactating.&#xD;
  &#xD;
           10. Participants with a history of hypersensitivity against the active ingredients or&#xD;
               excipients of golidocitinib or against similar chemical structures or drugs of the&#xD;
               same class. Contraindication to any agent in the CHOP chemotherapy regimen.&#xD;
  &#xD;
           11. Participants with any severe or poorly controlled systemic disease, such as poorly&#xD;
               controlled hypertension or active bleeding constitution, as judged by the investigator&#xD;
               or other evidence.&#xD;
  &#xD;
           12. Participants with an intercurrent illness that, in the opinion of the investigator,&#xD;
               may jeopardize compliance with the protocol, including any significant medical&#xD;
               condition, laboratory abnormality, or psychiatric disorder.&#xD;
  &#xD;
           13. Participants with psychological, familial, social, or geographical conditions that&#xD;
               preclude compliance with the program. Any condition that would confound the ability to&#xD;
               interpret study data.&#xD;
  &#xD;
           14. Participating in study planning and implementation.&#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>Keshu Zhou, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henan Cancer Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Keshu Zhou, Dr.</last_name>
      <phone>+86 (0371) 65587513</phone>
      <email>drzhouks77@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450008</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Keshu Zhou, Dr.</last_name>
        <phone>+86 (0371) 65587513</phone>
        <email>drzhouks77@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Henan Cancer Hospital</investigator_affiliation>
      <investigator_full_name>KeshuZhou</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prednisone</mesh_term>
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Doxorubicin</mesh_term>
      <mesh_term>Vincristine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05963347
  org study id: DZ2022J0003
  nct id: NCT05963347
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of
        golidocitinib in Combination with CHOP as the front-line Treatment for Participants with
        Peripheral T-cell Lymphomas (PTCL).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
  time frame: From first dose till 28 days post the last dose
  description: TEAE, lab test
  measure: Complete Response Rate
  time frame: From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
  description: Complete response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria
  measure: Objective Response Rate
  time frame: From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
  description: Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
  measure: Progression Free Survival
  time frame: From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year)
  description: Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
  measure: Duration of Response
  time frame: from first documented response till disease progression or death of any reason (up to 2 years)
  description: Duration of response assessed by investigator per Lugano 2014 criteria
  arm group label: Go-CHOP
  arm group type: Experimental
  description: Golidocitinib in combination with CHOP
  intervention type: Drug
  intervention name: Golidocitinib
  description: Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib.
  arm group label: Go-CHOP
  other name: AZD4205, DZD4205
  intervention type: Drug
  intervention name: CHOP Regimen
  description: CHOP will be administered in a 21-day cycle for a maximum of 6 cycles.
  arm group label: Go-CHOP
  other name: Cyclophosphamide, doxorubicin, vincristine, prednisone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Keshu Zhou, Dr.
  role: Principal Investigator
  affiliation: Henan Cancer Hospital
  last name: Keshu Zhou, Dr.
  phone: +86 (0371) 65587513
  email: drzhouks77@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Henan Cancer Hospital
  investigator full name: KeshuZhou
  investigator title: Professor
  mesh term: Lymphoma
  mesh term: Lymphoma, T-Cell
  mesh term: Lymphoma, T-Cell, Peripheral
  mesh term: Prednisone
  mesh term: Cyclophosphamide
  mesh term: Doxorubicin
  mesh term: Vincristine
  sharing ipd: No