NCT05949931招募中2 期
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)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Complete response rate （CRR）
研究概览
简要总结
This study is conducted to evaluate the safety and efficiency of Penpulimab combined with AVD in patients with newly- diagnosed advanced classic Hodgkin lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Concurrent penpulimab and AVD
Experimental
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.
干预措施: Concurrent penpulimab and AVD (Drug)
Sequential penpulimab and AVD
Experimental
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.
干预措施: Sequential penpulimab and AVD (Drug)
结局指标
主要结局
Complete response rate （CRR）
时间窗: 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
次要结局
- Overall survival (OS)(Up to 5 years)
- Complete response rate （CRR）(From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2))
- Objective response rate（ORR）(From first injection to 24 weeks (Arm 1) From first injection to 48 weeks (Arm 2))
- Progression-free Survival (PFS)(Up to 5 years)
- Safety indicators(Up to 5 years)
- Modified progression-free survival (mPFS)(Up to 5 years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic CancerPancreatic Adenocarcinoma MetastaticNCT06051851The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School177
已完成
2 期
A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT04736810Akeso28
进行中（未招募）
2 期
Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin LymphomaAnn Arbor Stage I Hodgkin LymphomaAnn Arbor Stage IA Hodgkin LymphomaAnn Arbor Stage IB Hodgkin LymphomaAnn Arbor Stage II Hodgkin LymphomaAnn Arbor Stage IIA Hodgkin LymphomaAnn Arbor Stage IIB Hodgkin LymphomaClassic Hodgkin LymphomaNCT03233347Academic and Community Cancer Research United83
进行中（未招募）
1 期
Trial of Immunotherapy With Avelumab and Pepinemab As Second Line For Patients With Metastatic Pancreatic AdenocarcinomaMetastatic Pancreatic AdenocarcinomaNCT05102721Vaccinex Inc.48
已完成
3 期
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseNCT00409682Abbott192