A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Complete remission (CR) rate
研究概览
简要总结
Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL
详细描述
This is a prospective, open-label, multicenter, randomized controlled clinical study conducted among previously untreated CD20-positive DEL participants. Subjects who meet the inclusion/exclusion criteria will be randomly assigned in a 1:1 ratio to either the test group or the control group after signing the informed consent form:
The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.
Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.
For patients with C1D14 ctDNA LFC < 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added.
If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
- •2. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%
- •3. Age ≥ 18 years old and ≤ 75 years old;
- •4. ECOG performance status score of 0, 1, or 2;
- •5. International Prognostic Index (IPI) > 1
- •6. No history of malignant tumor; no concurrent occurrence of other tumors;
- •7. Patients with an expected lifespan of at least 6 months, as determined by the researcher;
- •8. The patient or their legal representative must provide written informed consent before undergoing any special examinations or procedures in the study.
排除标准
- •1. Have previously received systemic or local treatments, including chemotherapy;
- •2. Have previously undergone autologous stem cell transplantation;
- •3. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
- •4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
- •5. Primary central nervous system lymphoma;
- •6. Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
- •7. Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5*10^9/L; B. Platelet count < 75 x 10^9/L; C. ALT or AST is 2 times higher than the upper limit of normal, and AKP and bilirubin are 1.5 times higher than the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
- •8. Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
- •9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- •10. Pregnant or lactating women;
- •11. Individuals infected with HIV.
- •12. Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;
研究组 & 干预措施
CR-CHOP
干预措施: CR-CHOP (Drug)
Innovative Treatment Group
The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.
Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.
For patients with C1D14 ctDNA LFC < 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added.
干预措施: C-Pola-R-CHP+X (Drug)
结局指标
主要结局
Complete remission (CR) rate
时间窗: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
次要结局
- 2-year progression-free survival (PFS) rate(2 years after enrollment)
- 2-year overall survival (OS) rate(2 years after enrollment)
研究者
Zhao Weili
Principal Investigator
Ruijin Hospital