Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades
研究概览
简要总结
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Histologically confirmed Hodgkins lymphoma
- •Relapsed or refractory disease after the first line of treatment
- •Age 18-70 years old
- •Ejection fraction greater than 50%
- •ECOG 0-2 status
- •Signed informed consent
- •No severe concurrent illness
排除标准
- •Uncontrolled bacterial or fungal infection at the time of enrollment
- •Requirement for vasopressor support at the time of enrollment
- •Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- •Karnofsky index <30%
- •Pregnancy
- •Somatic or psychiatric disorder making the patient unable to sign an informed consent
- •Active or prior documented autoimmune disease requiring systemic treatment.
研究组 & 干预措施
Main arm
Patients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT.
Patients with <CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT.
干预措施: Nivolumab (Drug)
结局指标
主要结局
1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades
时间窗: 12 months
2. Overall Response Rate (ORR) Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
时间窗: 12 months
次要结局
- Progression-Free Survival (PFS)(24 months)
- Overall Survival (OS)(24 months)
- 1. Duration of Response (DOR)(24 months)
研究者
Elena N.Parovichnikova
Vice-director Nathional Medical Research Center for Hematology Moscow Russia
National Research Center for Hematology, Russia