Efficacy and Safety of Cladribine Combined With BEAC ( Semustine, Etoposide, Cytarabine, Cyclophosphamide) Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This multi-center clinical study will evaluate the efficacy and safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma.
详细描述
Peripheral T-cell lymphomas (PTCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas originating from mature post-thymic T lymphocytes or NK/T cells. The treatment effect of patients receiving autologous hematopoietic stem cell transplantation (ASCT) is better than traditional chemotherapy, but the recurrence after transplantation is still as high as 50%. It is an urgent clinical problem to reduce the recurrence after PTCL transplantation. Cladribine can kill quiescent tumor cells, which is the main reason of tumor recurrence. Since 2018, our center has used cladribine combined with BEAC pretreatment regimen to treat 20 patients with PTCL. The PFS reached 68% at 2 years, which is about 15% higher than the previous classic BEAC regimen. This multi-center clinical study will further evaluate the efficacy and safety of Cladribine combined with BEAC pretreatment regimen in the Treatment of Peripheral T-cell Lymphoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old, no gender limit;
- •ECOG 0-2, estimated survival time ≥ 3 months;
- •Pathologically newly diagnosed with PTCL (except ALK+ anaplastic large cell lymphoma), with PR or CR after 6 cycles of induction chemotherapy;
- •Hb≥80g/L, ANC≥1.0×10^9/L, PLT≥75×10^9/L; TBIL≤1.5×ULN, ALT/AST≤2.0× ULN, Cr ≤1.5×ULN in the 14 days before enrollment
- •Have not received hematopoietic stem cell transplantation and other treatments within 4 weeks before enrollment;
- •The number of hematopoietic stem cells requires MNC ≥3×10^8/kg and/or CD34 cells ≥2×10^6/kg;
- •Informed consented
排除标准
- •Accompanied by severe cardiac insufficiency, cardiac ejection fraction <60%; or severe arrhythmia, intolerance of pretreatment;
- •Accompanied by severe pulmonary insufficiency (obstructive and or restrictive ventilatory disorders), intolerance of pretreatment;
- •Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 3 times higher than the upper limit of normal, intolerance of pretreatment;
- •Accompanied by severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal; or the 24-hour urine creatinine clearance rate Ccr is less than 50ml/min, intolerance of pretreatment;
- •Severe active infection before transplantation, intolerance of pretreatment;
- •Accompanied by brain dysfunction or severe mental illness, unable to understand or follow the research plan;
- •Pregnant or lactation；
- •Accompanied by other malignant tumors in need of treatment;
- •Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation.
研究组 & 干预措施
BEAC
Patients in this arm will receive BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT
干预措施: BEAC (Drug)
Cladribine combined with BEAC
Patients in this arm will receive Cladribine combined with BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT
干预措施: Cladribine combined with BEAC (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 Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007, or death from any cause, whichever occurred first.
次要结局
- Overall survival(Baseline up to data cut-off (up to approximately 2 years))
- Overall remission rate(3 months after the transplantation)
- Patient tolerance(Through the whole course of ASCT, an average of one month)
- Transplantation-related adverse reactions(Baseline up to data cut-off (up to approximately 5 years))
- Relapse rate(Baseline up to data cut-off (up to approximately 5 years))
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital