Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 主要终点
- Progress-free survival
研究概览
简要总结
Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival. This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy and transplantation.
详细描述
The eligibility criteria were pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification; age≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. Stage was defined according to the Ann Arbor system.
The Fujian Medical University Union Hospital approved this study before subjects were enrolled.
Treatment dosages were as follows:
days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous infusion 25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The regimen was repeated every 28 days for a maximum of six cycles.
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
- •Inclusion Criteria:
- •pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification;
- •age≥18 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),
- •adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
- •adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
- •normal coagulation function and electrocardiogram results.
- •willingness to provide written informed consent.
排除标准
- •MCL patients who do NOT response or are refractory to preview treatment.
- •Who do NOT sign the consent form.
- •whose life expectation is less than 6 months.
研究组 & 干预措施
Bortezomib,Fludarabine and Cytarabine
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
干预措施: Bortezomib (Drug)
Bortezomib,Fludarabine and Cytarabine
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
干预措施: Fludarabine (Drug)
Bortezomib,Fludarabine and Cytarabine
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
干预措施: Cytarabine (Drug)
结局指标
主要结局
Progress-free survival
时间窗: Follow-up to 36 months
Interval from registration to progression or death from any cause
次要结局
- Overall response rate(Up to 36 months)
研究者
Tingbo Liu
Professor of medicine
Fujian Medical University