Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) ：a Single Arm, Open Label, Multi-center Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Objective Response rate
研究概览
简要总结
This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed grade 1, 2, or 3A FL;
- •Patients received prior anti-lymphoma treatment;
- •At least one evaluable lesion according to 2014 Lugano criteria;
- •Age 18 years or older;
- •Eastern Cooperative Oncology Group (ECOG) of 0-2;
- •Life expectancy > 3 months;
- •Able to participate in all required study procedures;
- •Proper functioning of the major organs:
排除标准
- •Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;
- •Histological transformation of follicular lymphoma;
- •Known central nervous system lymphoma;
- •Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;
- •Subjects who have received prior treatment with ibrutinib, or other BTK inhibitors;
- •Uncontrolled active infection, with the exception of tumor-related B symptom fever;
- •Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug;
- •Subjects who progressed or become refractory while on treatment with PI3K inhibitors are excluded. However, subjects who were responding to PI3K inhibitors, but had treatment discontinued due to toxicity, are eligible;
- •Patients require treatment with strong CYP3A inhibitors;
- •Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening;
- •Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
研究组 & 干预措施
Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib
Induction therapy: Patients receive Orelabrutinib at a dose of 25 mg once daily on days 1-28 and rituximab at a dose of 375mg/m2 on day 1. Treatment cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
If patients achieve CR or PR or SD, they will be treated with maintenance therapy Maintenance therapy: Patients receive Orelabrutinib every day at a dose of 150mg for up to two years in the absence of disease progression or unacceptable toxicity.
干预措施: Orelabrutinib and Rituximab (Drug)
Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib
Induction therapy: Patients receive Orelabrutinib at a dose of 25 mg once daily on days 1-28 and rituximab at a dose of 375mg/m2 on day 1. Treatment cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
If patients achieve CR or PR or SD, they will be treated with maintenance therapy Maintenance therapy: Patients receive Orelabrutinib every day at a dose of 150mg for up to two years in the absence of disease progression or unacceptable toxicity.
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
Objective Response rate
时间窗: 2 years
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
次要结局
- Complete remission rate(2 years)
- Progression Free Survival(4 years)
- Overall Survival(4 years)
- Duration of Response(4 years)
- Percentage of Participants With Adverse Events(4 years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University