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Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma

Primary Purpose

Classic Hodgkin Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Concurrent penpulimab and AVD
Sequential penpulimab and AVD
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classic Hodgkin Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18-70 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months; classic Hodgkin lymphoma (cHL) confirmed by histopathology; The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass/maximum diameter of thoracic cavity>0.33; ② There are large masses with a diameter of>10cm; Have not received systemic anti classic Hodgkin lymphoma treatment; Measurable disease ; Adequate main organs function Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period. Exclusion Criteria: Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma; Classic Hodgkin lymphoma involves the central nervous system; Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment; Subjects who need to use glucocorticoid (>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration; Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known to have active pulmonary tuberculosis; Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases; Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia; Patients with evidence of bleeding constitution or medical history; Within 4 weeks before the first medication, any ≥ CTC AE level 3 bleeding events (such as digestive tract bleeding, perforation, etc.) occur; Concomitant diseases and medical history: Has experienced or currently suffers from other malignant tumors within 3 years. Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction); Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders; Subjects with any severe and/or uncontrollable disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Concurrent penpulimab and AVD

    Sequential penpulimab and AVD

    Arm Description

    Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.

    Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.

    Outcomes

    Primary Outcome Measures

    Complete response rate (CRR)
    Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses

    Secondary Outcome Measures

    Complete response rate (CRR)
    Percentage of participants achieving complete response evaluated by researchers
    Objective response rate(ORR)
    Percentage of participants achieve complete response and partial response
    Progression-free Survival (PFS)
    From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first
    Overall survival (OS)
    From randomization to the time of death from any cause.
    Safety indicators
    The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Full Information

    First Posted
    July 10, 2023
    Last Updated
    July 10, 2023
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05949931
    Brief Title
    Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma
    Official Title
    A Randomized, Open, Multicenter Phase II Clinical Trial of Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma (PENAHL Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Classic Hodgkin Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Concurrent penpulimab and AVD
    Arm Type
    Experimental
    Arm Description
    Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
    Arm Title
    Sequential penpulimab and AVD
    Arm Type
    Experimental
    Arm Description
    Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Concurrent penpulimab and AVD
    Intervention Description
    Participants will receive Penpulimab and AVD injection at the same time for a total of 6 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Sequential penpulimab and AVD
    Intervention Description
    Participants will receive penpulimab for 3 cycles; follewed by 6 cycles of AVD; finally, penpulimab for 3 cycles. Cycle length = 28 days, Penpulimab and AVD will be administered on D1 and D15 of each cycle.
    Primary Outcome Measure Information:
    Title
    Complete response rate (CRR)
    Description
    Percentage of participants achieving complete response evaluated by the Independent Review Committee (IRC) at the end of all treatment courses
    Time Frame
    From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
    Secondary Outcome Measure Information:
    Title
    Complete response rate (CRR)
    Description
    Percentage of participants achieving complete response evaluated by researchers
    Time Frame
    From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
    Title
    Objective response rate(ORR)
    Description
    Percentage of participants achieve complete response and partial response
    Time Frame
    From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)
    Title
    Progression-free Survival (PFS)
    Description
    From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first
    Time Frame
    Up to 5 years
    Title
    Overall survival (OS)
    Description
    From randomization to the time of death from any cause.
    Time Frame
    Up to 5 years
    Title
    Safety indicators
    Description
    The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 18-70 years old (when signing the informed consent form); ECOG score: 0 or 1 point; The expected survival period exceeds 3 months; classic Hodgkin lymphoma (cHL) confirmed by histopathology; The subject must be advanced patient, specifically defined as Ann Arbor stage III-IV or IIB with any of the following high-risk factors: ① maximum diameter of mediastinal mass/maximum diameter of thoracic cavity>0.33; ② There are large masses with a diameter of>10cm; Have not received systemic anti classic Hodgkin lymphoma treatment; Measurable disease ; Adequate main organs function Female subjects of childbearing age should agree to use contraceptives (such as Intrauterine device, contraceptives or condoms) during the study period and within 6 months after the end of the study; The serum or urine Pregnancy test was negative within 7 days before the study was included, and must be non-lactating subjects; Male participants should agree to use contraception during the study period and within 6 months after the end of the study period. Exclusion Criteria: Nodular lymphocyte dominated Hodgkin lymphoma or gray area lymphoma; Classic Hodgkin lymphoma involves the central nervous system; Subjects who have or are suspected to have active autoimmune diseases within the past 2 years, or have previously suffered from autoimmune diseases and are currently at high risk of recurrence and require systemic treatment; Subjects who need to use glucocorticoid (>10mg/day prednisone Equivalent dose) or other immunosuppressive drugs for systemic treatment within 14 days before the first administration. Inoculate or expect to receive live or attenuated live vaccines or mRNA vaccines within 4 weeks before the first administration; Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known to have active pulmonary tuberculosis; Having a history of immunodeficiency, including HIV positive or suffering from other acquired or congenital immunodeficiency diseases; Subjects with a known history of interstitial pneumonia, a history of non-infectious pneumonia, or highly suspected cases of interstitial pneumonia; Patients with evidence of bleeding constitution or medical history; Within 4 weeks before the first medication, any ≥ CTC AE level 3 bleeding events (such as digestive tract bleeding, perforation, etc.) occur; Concomitant diseases and medical history: Has experienced or currently suffers from other malignant tumors within 3 years. Multiple factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction); Patients with a history of abuse of psychotropic substances who are unable to quit or have mental disorders; Subjects with any severe and/or uncontrollable disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qingqing Cai, MD. PhD.
    Phone
    0086-20-87342823
    Email
    caiqq@sysucc.org.cn

    12. IPD Sharing Statement

    Learn more about this trial

    Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma

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