A Single-center, Randomized Controlled Clinical Study of Zanubrutinib Combined With Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Progression-free survival
研究概览
简要总结
This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.
详细描述
This trial includes 66 patients with recurrent or refractory DLBCL, who will be randomly divided into a 1:1 combination of zanubrutinib and BEAM regimen pretreatment (experimental group) or a standard BEAM regimen pretreatment (control group), and then undergo ASCT treatment. The entire trial includes a screening period (before the start of autologous stem cell transplantation pretreatment), a treatment period (-8 days to -2 days, a total of 7 days), and a follow-up period (2 years after autologous stem cell transplantation)
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;
- •18≤ age ≤65 years old, male or female;
- •ECOG score 0-2;
- •No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
- •White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;
- •Total bilirubin ≤1.5× upper normal value (ULN);
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN
- •Creatinine clearance was 44-133 mmol/L;
- •No cardiac dysfunction;
- •Life expectancy over 3 months;
- •The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.
排除标准
- •Previously received autologous hematopoietic stem cell transplantation;
- •Suffering from serious complications or severe infection;
- •Previous treatment with selinexor;
- •Central nervous system lymphoma was excluded;
- •A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
- •Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
- •HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
- •Left ventricular ejection fraction ≦ 50%;
- •Laboratory test value during screening;
- •① Neutrophils <1.5×109/L; Platelet <75×109/L;
- •② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;
- •③ The creatinine level is higher than 1.5 times the upper limit of normal value;
- •Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
- •Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
- •Pregnant or lactating women;
- •The researcher judged that the patients were not suitable for this study.
研究组 & 干预措施
zanubrutinib combined with BEAM
zanubrutinib combined with camustine, etoposide, cytarabine, and mafaran (BEAM)
干预措施: zanubrutinib combined with BEAM (Drug)
BEAM
camustine, etoposide, cytarabine, and mafaran (BEAM)
干预措施: BEAM (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Baseline up to data cut-off (up to approxiamately 2 years)
Progression-free survival was defined as the time from the data of ASCT until the date of the first documented day of disease progression or relapse, using Lugano criteria, or death from an cause, whichever occured first.
次要结局
- Overall survival(Baseline up to data cut-off (up to approxiamately 2 years))
- Complete remission rate(3 months after the transplantation)
- The time of hematopoietic reconstruction(2 months after the transplantation)
- Transplantation-related adverse reactions(Baseline up to data cut-off (up to approxiamately 4 years))