An Open-Label, Multicentre, Randomized Phase II Non-Inferiority Trial Comparing 4 vs 6 Cycles of CHP (21-Day Intervals) Both Combined With 6 Cycles of Polatuzumab Vedotin and Rituximab in Previously Untreated Diffuse Large B-Cell Lymphoma Patients With IPI 0-1
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Complete response rate (CR)
研究概览
简要总结
This is an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab
详细描述
The POLARIX study demonstrated that the Pola-R-CHP regimen (replacing vincristine in R-CHOP with Pola) significantly improves progression-free survival (PFS) and is safer than traditional R-CHOP. The FLYER study suggested that 4 cycles of R-CHOP followed by 2 additional doses of rituximab in young, low-risk DLBCL patients (IPI 0-1) are as effective as 6 cycles of R-CHOP and result in lower toxicity. Based on the efficacy of Pola-R-CHP and the potential for reducing treatment intensity in low-risk patients, this study will evaluate whether 4 cycles of Pola-R-CHP followed by 2 cycles of Pola-R are non-inferior to 6 cycles of Pola-R-CHP in treatment-naive low-risk DLBCL patients (IPI 0-1), with a potentially better safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL)
- •Age ≥18yo and ≤80yo at the time of signing consent
- •International Prognostic Index (IPI) score 0-1
- •Have measurable disease on a pre-chemotherapy PET/CT, defined as at least one bi-dimensionally measurable nodal lesion of >1.5cm in longest dimension, or at least one bi-dimensionally measurable extranodal lesion of >1.0cm in longest dimension
- •Life expectancy greater than or equal to (>/=)12 months
- •Left ventricular ejection fraction (LVEF) >/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- •Adequate hematologic function
- •Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs.
- •Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.
排除标准
- •Patients with central nervous system or primary mediastinal lymphoma, and patients with transformed lymphoma.
- •Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.
- •Pregnant or lactating women.
- •Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; positive by RNA polymerase chain reaction [PCR]) infection.
- •Patients with concurrent other tumors or a history of tumors, or who have received anti-tumor treatment (including major surgery) within the last 4 weeks.
- •Allergic reactions to polatuzumab vedotin.
- •Other conditions where the investigator deems the patient ineligible for this study.
研究组 & 干预措施
4×Pola-RCHP followed by 2×Pola-R
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles.
This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
干预措施: Polatuzumab Vedotin (Drug)
4×Pola-RCHP followed by 2×Pola-R
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles.
This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
干预措施: Rituximab (Drug)
4×Pola-RCHP followed by 2×Pola-R
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles.
This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
干预措施: Cyclophosphamide (Drug)
4×Pola-RCHP followed by 2×Pola-R
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles.
This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
干预措施: Doxorubicin (Drug)
4×Pola-RCHP followed by 2×Pola-R
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles.
This Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.
干预措施: Prednisone (Drug)
6×Pola-RCHP
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles.
This regimen is repeated for 6 cycles
干预措施: Polatuzumab Vedotin (Drug)
6×Pola-RCHP
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles.
This regimen is repeated for 6 cycles
干预措施: Rituximab (Drug)
6×Pola-RCHP
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles.
This regimen is repeated for 6 cycles
干预措施: Cyclophosphamide (Drug)
6×Pola-RCHP
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles.
This regimen is repeated for 6 cycles
干预措施: Doxorubicin (Drug)
6×Pola-RCHP
Participants will receive:
Polatuzumab Vedotin: 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of every cycle for 6 cycles.
Rituximab: 375 milligrams per square meter (mg/m^2) IV on Day 1 of every cycle for 6 cycles.
Cyclophosphamide: 750 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg/m^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles.
This regimen is repeated for 6 cycles
干预措施: Prednisone (Drug)
结局指标
主要结局
Complete response rate (CR)
时间窗: up to the end of 6 cycles of treatment (each cycle is 28 days)]
To assess the complete response rate (CR) at the end of treatment with Treatment
次要结局
- Overall Response Rate (ORR)(up to the end of 6 cycles of treatment (each cycle is 28 days))
- Duration of Response (DoR)(up to 2 years)
- Progression-free survival (PFS)(up to 2 years)
- To identify biomarkers(up to 2 years)