A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2 years progression-free survival
研究概览
简要总结
This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.
详细描述
All the eligible patients will be treated with ZR-CHOP regimen (Rituximab 375mg/m2 IV d1, cyclophosphamide 750mg/m2 IV d1, epirubicin 70mg/m2 IV d1, vindesine 4mg IV d1，prednison 60mg/m2 d1-5 PO). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of ZR-CHOP.
The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.
During the following-up, surveillance physical examination and CT scans should be performed every 6 months for 2 years to determine the status of disease.
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
- •The patient volunteered to participate in the study and signed the Informed Consent
- •Age ≥18 years old ≤70 Years old, male or female
- •Expected survival ≥ 12 weeks
- •Intravascular large B-cell lymphoma confirmed by cytology or histology according to WHO2016 criteria
- •Never received any anti-tumor therapies.
- •Adequate organ function and adequate bone marrow reserve
排除标准
- •Malignant tumors other than IVLBCL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
- •Active HIV, HBV, HCV or treponema pallidum infection
- •Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
- •Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
研究组 & 干预措施
Zanubrutinib combined with R-CHOP
The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.
After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
干预措施: Zanubrutinib (Drug)
Zanubrutinib combined with R-CHOP
The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.
After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
干预措施: Rituximab (Drug)
Zanubrutinib combined with R-CHOP
The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.
After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
干预措施: Cyclophosphamide (Drug)
Zanubrutinib combined with R-CHOP
The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.
After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
干预措施: Epirubicin (Drug)
Zanubrutinib combined with R-CHOP
The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.
After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
干预措施: Vindesine (Drug)
Zanubrutinib combined with R-CHOP
The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.
After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.
干预措施: Prednisone (Drug)
结局指标
主要结局
2 years progression-free survival
时间窗: from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing.
次要结局
- overall response rate(ORR)(6 weeks after the end of 8 cycles of induction (each cycle is 21 days).)