A Prospective, Single-arm, Multicenter Clinical Study of Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Patients with Frail Treatment-naive Non-germinal Center Subtype Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- CRR
研究概览
简要总结
This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histopathologically confirmed DLBCL;
- •The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;
- •Non-germinal center (Non-GCB) type;
- •ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder > 1.5 cm, or at least one extranodal lesion > 1.0 cm in the longest diameter; ⑦ Adequate organ function;
- •Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.
排除标准
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;
- •Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC < 1.5 x 109/L, PLT < 80 x 109/L b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d） Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance < 60 mL/min (estimated by C OC kcroft-Gault formula); ③ HIV Infection;
- •HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA detection is still required; if the results are positive, antiviral therapy is required, and HBV DNA negative before enrollment;
- •Requires continuous treatment with strong and moderate CYP3A inhibitors or CYP3A Induction agents. Patients who have taken strong and moderate CYP3A inhibitors or CYP3A Induction agents (or have taken these agents within 5 half-lives) within 7 days prior to the first dose of study drug should not be enrolled; ⑥ Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as Syndrome malabsorption, gastric or Small intestinal resection, symptomatic Inflammatory bowel disease or partial or complete Intestinal obstruction; ⑦ Other concurrent and uncontrolled medical conditions that, in the opinion of the investigators, would affect the patients' participation in the study, including patients with Psychosis or other patients known or suspected to be unable to fully comply with the study protocol.
研究组 & 干预措施
PRO
The drugs involved in this trial include Polatuzumab, Rituximab, and orelabrutinib in 21-day cycles.
The dose and administration method of the study drug were as follows:
- Polatuzumab: 1.8 mg/kg, IV, D1;
- Rituximab: 375 mg/m2, IV, D1;
- Orelabrutinib: 150 mg/time, qd, po, D1-21;
干预措施: Polatuzumab vedotin (Drug)
PRO
The drugs involved in this trial include Polatuzumab, Rituximab, and orelabrutinib in 21-day cycles.
The dose and administration method of the study drug were as follows:
- Polatuzumab: 1.8 mg/kg, IV, D1;
- Rituximab: 375 mg/m2, IV, D1;
- Orelabrutinib: 150 mg/time, qd, po, D1-21;
干预措施: Rituximab (Drug)
PRO
The drugs involved in this trial include Polatuzumab, Rituximab, and orelabrutinib in 21-day cycles.
The dose and administration method of the study drug were as follows:
- Polatuzumab: 1.8 mg/kg, IV, D1;
- Rituximab: 375 mg/m2, IV, D1;
- Orelabrutinib: 150 mg/time, qd, po, D1-21;
干预措施: Orelabrutinib (Drug)
结局指标
主要结局
CRR
时间窗: 6 months
Complete response rate (CRR) at the end of Induction treatment (6 cycles)
次要结局
- ORR(6 months)
- EFS(24 months)
- 2y-PFS rate(24 months)
- OS(24 months)
- Safety profile(24 months)
研究者
Wenyu Shi
Director, Department of Oncology
Affiliated Hospital of Nantong University