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

Официальное название

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)

Обзор

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

Вмешательства

• Препарат Concurrent penpulimab and AVD
  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.
• Препарат Sequential penpulimab and AVD
  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.

Первичные конечные точки

• Complete response rate （CRR） [Срок оценки: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]

Вторичные конечные точки (6)

• Complete response rate （CRR） [Срок оценки: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]
• Objective response rate（ORR） [Срок оценки: From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2)]
• Progression-free Survival (PFS) [Срок оценки: Up to 5 years]
• Modified progression-free survival (mPFS) [Срок оценки: Up to 5 years]
• Overall survival (OS) [Срок оценки: Up to 5 years]
• Safety indicators [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT05949931 · B2023-092

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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