Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination with RCHOP in first-line treatment of patients with DH or TH lymphoma.
详细描述
This is a prospective, single-arm, single-center clinical study evaluating the first-line treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages: screening, treatment and follow-up period. The screening period was 28 days before the first dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy during treatment. Objective effective rate, safety and survival data were observed during the experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered the follow-up period, during which imaging evaluation (enhanced CT at focal site is recommended) was performed at the following intervals: once every 3 months for 2 years, once every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.
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
- •Volunteer to participate in clinical studies
- •Age: 18~75 (inclusive), male and female.
- •Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangement.
- •No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
- •ECOG score is 0-
- •there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria.
- •Adequate organ and bone marrow function.
- •Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- •Serum pregnancy test negative
排除标准
- •Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1) Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement.
- •known central nervous system involvement.
- •received prior anti-tumor therapy
- •Is participating in another clinical study or is receiving the first investigational drug less than 4 weeks after the completion of treatment in the previous clinical study
- •Had other malignant tumors in the past 5 years
- •Major surgery was performed within 28 days prior to study initiation
- •Cardiovascular function is unstable
- •Active infection
研究组 & 干预措施
Selinexor+RCHOP
Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5
干预措施: Selinexor+RCHOP (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: From date of first day of treatment until the date of last day of treatment
CR plus PR
次要结局
- PFS(From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months)
- OS(From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months)
- AE and SAE(From date of first day of treatmentuntil 30 day after last treatment)
研究者
Yang haiyan
Director
Zhejiang Cancer Hospital