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NCT Number: NCT05949931

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Qingqing Cai

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥18 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.

Treatment and study plan

Concurrent penpulimab and AVD

Drug

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.

Sequential penpulimab and AVD

Drug

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 outcomes

  1. Complete response rate (CRR)

    Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)

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

Secondary outcomes

  1. Complete response rate (CRR)

    Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)

    Percentage of participants achieving complete response evaluated by researchers

  2. Objective response rate(ORR)

    Time frame: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)

    Percentage of participants achieve complete response and partial response

  3. Progression-free Survival (PFS)

    Time frame: Up to 5 years

    From randomization to the first occurrence of disease progression as determined by the investigator, or death due to any cause, whichever occurs first

  4. Modified progression-free survival (mPFS)

    Time frame: Up to 5 years

    the time to progression, death, or noncomplete response and use of subsequent anticancer therapy.

  5. Overall survival (OS)

    Time frame: Up to 5 years

    From randomization to the time of death from any cause.

  6. Safety indicators

    Time frame: Up to 5 years

    The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

0086-20-87342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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