The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.
详细描述
In this study, elderly DLBCL patients will be treated with ZR2 regimen for the first-line treatment. Investigators will compare the complete response rate, survival and incidence of adverse reactions between the RCHOP/RCDOP chemotherapy and the ZR2 regimen. In addition, immune function tests will be performed before treatment and every 2 courses after treatment, including peripheral blood lymphocyte-monocyte ratio, cytokines, immunoglobulins, T and B cells and their quantitative analysis. Patients with ZR2 regimen will undergo gene second-generation sequencing before treatment to compare the gene mutation differences between complete response (CR) and ≤ partial response (PR) in the efficacy of ZR2 regimen, in order to find biomarkers with better efficacy in ZR2 treatment. Moreover, investigators intend to conduct pharmacokinetics/pharmacodynamics (PK/PD) correlation analysis of ZR2 regimen and pharmacoeconomic evaluation of the two regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed DLBCL
- •Without treatment
- •≥ 65 years old
- •Measurable lesions on CT or PET-CT before treatment
- •Life expectancy of at least 3 months
- •Voluntary participation with the consent of the patient
- •Heart, kidney, liver and other organ function evaluation were basically normal before treatment
排除标准
- •Patients who previously received chemotherapy
- •Uncontrolled cardiovascular diseases, cerebrovascular diseases, thrombotic diseases, autoimmune diseases and serious infectious diseases
- •Laboratory indicators before enrollment (unless caused by lymphoma):
- •Neutrophils < 1.5 × 10^9/L
- •Platelets < 80 × 10^9/L
- •Alanine aminotransferase or aspartate aminotransferase > 2 × ULN
- •Alkaline phosphatase or bilirubin > 1.5 × ULN
- •Creatinine > 1.5 × ULN
- •Patients who cannot comply with the agreement due to mental diseases or other unknown reasons such as pregnancy and lactation
- •HIV infection
- •If HBsAg is positive, HBVDNA should be tested, and patients with positive DNA cannot be enrolled; if HBsAg is negative and HBcAb is positive (regardless of HBsAb status), HBVDNA should be tested, and patients with positive DNA cannot be enrolled
- •Other uncontrolled medical conditions that may interfere with the study
研究组 & 干预措施
Zanubrutinib+Rituximab+Lenalidomide
The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles.
Dosage:
Zanubrutinib, 160 mg bid, po, day 2-21;
Lenalidomide, 10-20 mg qd, po, day 2-14;
Rituximab, 375 mg/m², ivgtt, day 1.
Maintenance therapy:
Patients who receive complete response or partial response after induction therapy will receive lenalidomide 10-20 mg qd po during 1-21 days in every 28 days, for a maximum of 2 years.
干预措施: Zanubrutinib+Rituximab+Lenalidomide (Drug)
RCHOP/RCDOP
The RCHOP/RCDOP regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles.
Dosage:
Rituximab, 375 mg/m², ivgtt, day 1;
Cyclophosphamide, 500-750 mg/m², ivgtt, day 2;
Doxorubicin, 50 mg/m², ivgtt day 2 (liposomal doxorubicin, 20-30 mg/m², ivgtt day 2 or Epirubicin, 50-60 mg/m², ivgtt day 2);
Vincristine, 1.4 mg/m², iv day 2 or vindesine, 3mg/m², iv day 2;
Prednisone, 100 mg qd, po day 2-6.
干预措施: RCHOP/RCDOP (Drug)
结局指标
主要结局
Complete response rate
时间窗: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).
Percentage of participants with complete response is determined on the basis of investigator assessments according to 2014 Lugano criteria.
次要结局
- Overall survival(Baseline up to data cut-off (up to approximately 3 years).)
- Progression free survival(Baseline up to data cut-off (up to approximately 3 years).)
- Incidence rate of adverse events(From enrollment to study completion, a maximum of 3 years.)
- Direct medical costs(At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).)
- EQ-5D scores(At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).)
- Maximum plasma concentration(The Cmax of zanubrutinib is determined at 2h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the Cmax of lenalidomide is determined at 1h postdose on day 2 of Cycle 2 (each cycle is 21 days).)
- Area under the plasma concentration-time curve(The AUC of zanubrutinib is determined at predose (0h), 2h and 24h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the AUC of lenalidomide is determined at predose (0h), 1h and 24h postdose on day 2 of Cycle 2 (each cycle is 21 days).)
- Steady-state trough concentration(The Css,min of zanubrutinib is determined at 24h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the Css,min of lenalidomide is determined at 24h postdose on day 2 of Cycle 2 (each cycle is 21 days).)
研究者
Haige Ye
Chief Physician
First Affiliated Hospital of Wenzhou Medical University