Single-arm, Multi-center and Phase II Clinical Trial of Camrelizumab Combined With AVD (Epirubicin, Vincristine and Dacarbazine) in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- complete metabolic response rate (CMRR)
研究概览
简要总结
This is a prospective single-arm, multi-center and phase II clinical trial to observe the efficacy and safety of Camrelizumab combined with AVD in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.
详细描述
Hodgkin's lymphoma (HL) is a kind of malignant tumor of the lymph system, approximately 95% of which are classical hodgkin's lymphoma (cHL). Currently, ABVD and BEACOPP are commonly used in the first-line treatment for cHL. There are about one third of patients, whose pre-treatment assessment are mainly advanced cHL, suffering relapse and drug resistance. PD-1/PD-L1 signaling pathway plays an important role in the development and progression of cHL. Nivolumab and Pembrolizumab have been used in the therapy in relapsed and refractory patients with cHL. Camrelizumab, a humanized anti-PD-1 IgG4 monoclonal antibody, is independently developed in China. The goal of our trial is to assess the efficacy and safety of Camrelizumab combined with AVD (Epirubicin, Vincristine and Dacarbazine) in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 75 years old (including 18 and 75)
- •Diagnosed as advanced classical hodgkin's lymphoma based on histopathology
- •Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)
- •No receiving chemotherapy before enrollment
- •Having at least one measurable lesions
- •World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
- •Life expectancy no less than 3 months
- •enough main organ function
- •Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- •Agreeing to sign the written informed consents
排除标准
- •Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma
- •Diagnosed as central nervous system lymphoma
- •usage of immunosuppressants before enrollment and the dose of immunosuppressant used >10mg / day oral prednisone for more than 2 weeks
- •Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4
- •Active autoimmune disease
- •Vaccination with anti-tumor vaccine or other immune treatments less than 3 months
- •Serious surgery and trauma less than two weeks
- •Other malignant tumor history or active malignant tumor need be treated
- •Systemic therapy for serious acute/chronic infection
- •Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- •Active tuberculosis
- •Vaccination with live attenuated vaccine less than 4 weeks
- •HIV-positive, AIDS patients and untreated active hepatitis
- •Researchers determine unsuited to participate in this trial
研究组 & 干预措施
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
干预措施: Camrelizumab (Drug)
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
干预措施: Epirubicin (Drug)
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
干预措施: Vincristine (Drug)
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
干预措施: Dacarbazine (Drug)
结局指标
主要结局
complete metabolic response rate (CMRR)
时间窗: every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days)
the proportion of patients who achieved a complete metabolic response (CMR) as their best overall response (BOR) from the first dose of study treatment through the end-of-treatment (EOT) assessment
次要结局
- 2-year progression-free survival(from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days))
- incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations(from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days))
- objective response rate(every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days))
- duration of complete response(DoCR)(The time from the date of first documented complete response until the date of first documented disease recurrence, progression, or death from any cause, whichever occurs first, assessed up to 10 years.)
- overall survival(from date of the first cycle of treatment to the date of death from any cause, assessed up to 10 years (each cycle is 28 days))
研究者
Yanyan Liu
Director
Henan Cancer Hospital