A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus a Placebo Plus ICE Regimen in Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy Failure
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This phase III trial studies the side effects of sintilimab to see how well it works when given together with ifosfamide, carboplatin, and etoposide in treating patients with classic Hodgkin lymphoma that does not respond to first-line standard chemotherapy.
详细描述
randomized, double-blind, two arms , multicenter
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed consent
- •Histopathologically confirmed cHL
- •Failed first-line standard combination chemotherapy
- •One measurable lesion (Lugano 2014)
- •Eastern Cooperative Oncology Group (ECOG) of 0-1
- •Male or female aged ≥18 years
- •Patients must have adequate organ and bone marrow function
排除标准
- •Patients must not have known central nervous system (CNS) involvement
- •Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-L1 agents, anti-PD-L2 agents, or anti-CTLA-4 monoclonal antibodies
- •Patients may not simultaneously participate in another interventional clinical study
- •Patients may not receive any other investigational agents within 4 weeks of study registration
- •Patients may not receive any other form of immunosuppressive therapy within 4 weeks prior to the first dose of study drug
- •Patients may not receive live attenuated vaccines within 4 weeks prior to the first dose of study drug (or plan to receive live attenuated vaccines during the study period)
- •Patients with known immunodeficiency are ineligible
- •Patients with known active TB (Bacillus tuberculosis) are ineligible
- •Patients must not have had prior allogeneic stem cell transplantation or allogeneic organ transplantation
- •Patients must not be pregnant or breastfeeding
研究组 & 干预措施
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Sintilimab (Biological)
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Carboplatin (Drug)
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Etoposide (Drug)
Treatment (Sintilimab, etoposide, ifosfamide, carboplatin)
Patients receive sintilimab IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Sintilimab in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Ifosfamide (Drug)
Treatment (placebo, etoposide, ifosfamide, carboplatin)
Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Placebo (Drug)
Treatment (placebo, etoposide, ifosfamide, carboplatin)
Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Carboplatin (Drug)
Treatment (placebo, etoposide, ifosfamide, carboplatin)
Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Etoposide (Drug)
Treatment (placebo, etoposide, ifosfamide, carboplatin)
Patients receive placebo IV on day 1, etoposide IV on days 1-3 of courses 1-6, carboplatin IV on day 2 of courses 1-6, and ifosfamide IV on day 1-3 of courses 1-6. Placebo in combination with ICE chemotherapy repeats every 21 days for 6 courses.
干预措施: Ifosfamide (Drug)
结局指标
主要结局
PFS
时间窗: 44months
次要结局
未报告次要终点