A Prospective and Exploratory Clinical Study of Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Complete response rate(CRR)
研究概览
简要总结
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
详细描述
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 years unfit or frail
- •There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
- •Histologically confirmed treatment-naive DLBCL.
- •Life expectancy is>3 months.
- •appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation
- •Adequate bone marrow reserve is defined as:
- •Hemoglobin ≥8g/dL, platelet count ≥75×10^9/L, Absolute neutrophil value ≥1.0×10^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10^9/L, absolute neutrophil count ≥0.75×10^9/L.
- •Patients have the ability to understand and are willing to provide written informed consent.
- •Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
排除标准
- •Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
- •Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
- •Uncontrolled active infection;
- •Co-existence of other tumors requiring treatment or intervention;
- •DLBCL involving central nervous system;
- •Current or expected need for systemic corticosteroid treatment;
- •Previous or current history of vascular embolism;
- •Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
- •In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the study.
研究组 & 干预措施
Pro-pola regimen
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients not achieving mRR (defined as complete remission [CR], partial remission [PR], and mini response [miniR; lesion reduction: 25.0%-50.0%]) were withdrawn from the study. Patients achieving mRR (with a lesion reduction of ≥25%) received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
干预措施: Induction therapy-Pro regimen (Drug)
Pro-pola regimen
The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients not achieving mRR (defined as complete remission [CR], partial remission [PR], and mini response [miniR; lesion reduction: 25.0%-50.0%]) were withdrawn from the study. Patients achieving mRR (with a lesion reduction of ≥25%) received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.
干预措施: Consolidation therapy-Pro-pola regimen (Drug)
结局指标
主要结局
Complete response rate(CRR)
时间窗: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
The rate of patients who achieved CR after 6 cycles of Pro-pola regimen
次要结局
- Objective response rate(ORR)(At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days))
- Main adverse reactions(From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days))
- 2-year progression-free survival(PFS)(From the enrollment to 2-year after the treatment of last patient)
- 2-year overall survival(OS)(From the enrollment to 2-year after the treatment of last patient)