A Single-center, Randomized Controlled Clinical Study of Selinexor Combined With BEAM as a Preconditioning Regimen for ASCT in Relapsed and Refractory Diffuse Large B-cell Lymphoma With MYC Positive
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 82
- 主要终点
- Progression free survival
研究概览
简要总结
To evaluate the efficacy and safety of selinexor combined with BEAM pretreatment regimen in ASCT of recurrent and refractory DLBCL patients with immunohistochemical positive for MYC
详细描述
This trial included 82 patients, who were randomly divided into pre-treatment with selinexor combined with BEAM regimen (experimental group) or BEAM regimen (control group) according to 1:1, and then underwent ASCT therapy. The trial included a screening period, a treatment period (2 weeks before and after transplantation), and a follow-up period (2 years after autologous transplantation). At 3, 6, 9 and 18 months after ASCT, blood routine, blood biochemistry, B-ultrasound of liver, bile, pancreas, spleen and lymph node, and whole body enhanced CT were performed. At 1 and 2 years after ASCT, blood routine, blood biochemistry, and whole body PET-CT evaluation were performed until the end of the study.
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;
- •The subjects tested positive for MYC in primary or pre-transplant lymphoma lesions;
- •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
selinexor combined with BEAM pretreatment regimen
Patients in this arm will receive selinexor combined with BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.
干预措施: selinexor combined with BEAM regimen (Drug)
BEAM pretreatment regimen
Patients in this arm will receive BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.
干预措施: BEAM regimen (Drug)
结局指标
主要结局
Progression free survival
时间窗: Baseline up to data cut-off (up to approximately 2 years)
Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from an cause, whichever occurred first.
次要结局
- Overall survival(Baseline up to data cut-off (up to approximately 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 approximately 4 years))