A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- PFS（Progression-free survival）
研究概览
简要总结
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.
详细描述
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen. . Patients who achieve CR will continue with chidamide maintenance therapy (20mg, D1,4,8,11) or opt for autologous hematopoietic stem cell transplantation after completion of induction therapy, with maintenance therapy recommended for at least 1 year (unless intolerable side effects or disease progression occur). Concurrent follow-up assessment (patients will enter the follow-up period described in the time and event table) until the end of the specified follow-up period (total study duration is 3 years) or until the patient meets the exit criteria.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
- •Pathologically confirmed a combination of TP53 mutation and del(17p);
- •Age ≥ 18 years old, ≦75 years old;
- •ECOG physical status score of 0, 1 or 2;
- •No previous history of malignant tumors; No other tumors occurred simultaneously;
- •Patients judged by the investigator to have a life expectancy of at least 6 months;
- •The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
- •International prognostic Index (IPI) >1 score.
排除标准
- •Have previously received systemic or local treatment including chemotherapy;
- •Previously received autologous stem cell transplantation;
- •Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;
- •Primary central nervous system lymphoma;
- •Left ventricular ejection fraction ≤ 50%;
- •Laboratory test values at the time of screening (unless due to lymphoma); A. Neutrophils <1.5*109/L; B. Platelet <75*109/L; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal.
- •D. Creatinine levels higher than 1.5 times the upper limit of normal
- •Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study.
- •Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- •Pregnant or lactating women;
- •People living with HIV.
- •Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.
研究组 & 干预措施
CDR-CHOP
Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.
干预措施: CDR-CHOP (Drug)
结局指标
主要结局
PFS（Progression-free survival）
时间窗: 1-year
PFS, defined as the time from treatment to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator
次要结局
- CRR（Complete response rate）(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days])
- OS（overall survival）(2-year)
- ORR（overall response rate）(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days])
研究者
Zhao Weili
Principal Investigator
Ruijin Hospital