BuEAM Conditioning for Autologous Stem Cell Transplantation (ASCT) to Treat Diffuse Large B Cell Lymphoma (DLCBL)
Busulfan, Etoposide, Cytarabine and Melphalan (BuEAM) as a Conditioning for Autologous Stem Cell Transplantation in Patients With Diffuse Large B Cell Lymphoma (DLCBL) Previously Treated With Rituximab Based Regimen
研究概览
详细说明
Among the high-dose conditioning regimens commonly used in patients with NHL are BEAM (BCNU, etoposide, cytarabine, and melphalan), BEAC (BCNU, etoposide, cytarabine, and cyclophosphamide), CBV (cyclophosphamide, carmustine, etoposide), and combination regimen with total body irradiation. Three-year progression free survival of patients with NHL received above high-dose chemotherapy followed by autologous stem cell rescue was reported as 40-50%, which is still unsatisfactory.
Busulfan (Bu)-based preparative regimens, which are commonly used with allogeneic SCT have also been studied with ASCT for lymphomas.
The development of intravenous busulfan achieved 100% bioavailability bypassing the oral route and increased safety and reliability of generating therapeutic busulfan levels, maximizing efficacy.
Recently, one prospective study showed that a combination conditioning regimen of i.v. busulfan, cyclophosphamide, etoposide was found to be well tolerated and seemed to be effective in patients with aggressive NHL.
Another prospective study for multiple myeloma patients showed that i.v. busulfan and melphalan conditioning regimen made no grade 3-4 non-hematological complication.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Busan、大韩民国
- 招聘中
- Inje University Busan Paik Hospital
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接触:
- Won Sik Lee, Dr. PhD.
- 电话号码:+82-51-890-6407
- 邮箱:wonsik112@gmail.com
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首席研究员:
- Won Sik Lee, M.D. PhD.
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Seoul、大韩民国
- 招聘中
- Seoul National University Hospital
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首席研究员:
- Sung Soo Yoon, M.D. Ph.D.
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Seoul、大韩民国
- 招聘中
- Asan Medical Center, University of Ulsan
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首席研究员:
- Je Hwan Lee, M.D. Ph.D.
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Seoul、大韩民国
- 招聘中
- Yeonsei University Hospital
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首席研究员:
- Jin Seok Kim, M.D. Ph.D.
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Ulsan、大韩民国
- 招聘中
- Ulsan University Hospital
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首席研究员:
- Hawk Kim, M.D. Ph. D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with a high-intermediate/high risk international prognostic index at a diagnosis or with salvage chemotherapy-sensitive relapse/refractory non Hodgkin's lymphoma
- Patients with histologically confirmed diffuse large B cell lymphoma at diagnosis
- Patients treated with rituximab based regimen previously
- Patients who have not received therapy with high-dose chemotherapy and stem cell transplantation
- Life expectation of at least 3 months
- ECOG performance status ≤ 2 (See Appendix II)
- Adequate hepatic function (serum bilirubin less than 2.0 mg/dL, AST and ALT less than three times the upper normal limit)
- Adequate renal function (serum creatinine less than 2.0 mg/dL).
- Adequate cardiac function (ejection fraction ≥ 45% on MUGA scan or echocardiogram).
- Adequate bone marrow function (ANC ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3).
- All patients are fully informed about the nature and purpose of this study and informed consent should be given before the start of treatment. All patients should fully understand the right of trial abandon without any disadvantage
Exclusion Criteria:
- Patients with central nervous system involvement of lymphoma
- Patients positive for human immunodeficiency virus
- Pregnant or breast feeding woman
- Young woman without pregnancy test prior to treatment or pregnancy test reveals positive.
- Young woman without a reliable and proper contraceptive method
- Man being not willing to contraception
- Concurrent history of neoplasm other than NHL with life expectancy less than 3 months (except for curatively treated non-melanoma skin cancer or in-situ uterine cervix cancer).
- History of clinically significant cardiac dysfunction (e.g. congestive heart failure, symptomatic coronary artery disease, medically uncontrolled arrhythmia) or myocardial infarction within 12 months
- A psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
- Significant infection or uncontrolled bleeding
- Enrollment of other clinical trials within 4 weeks prior to treatment
- Any preexisting medical condition of sufficient severity to prevent full compliance with the study
- Patient being not willing to or unable to obey study protocol
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:BuEAM: Experimental
BuEAM: Experimental Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day Intervention: Drug: Busulfan, etoposide, cytarabine, and melphalan
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Busulfan 3.2 mg/kg/d for 2 days Etoposide 400 mg/m2/d for 2days Cytarabine 1 g/m2 for 2 days Melphalan 140 mg/m2 for 1 day
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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progression-free survival
大体时间:three year
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three year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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总生存期
大体时间:三年
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三年
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Response rate according to the International Working Group criteria
大体时间:after 2 month
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after 2 month
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不良事件
大体时间:从调理开始到放电
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从调理开始到放电
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•Pharmacogenetic study
大体时间:After 3 years
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Pharmacogenetic study for predictive or prognostic markers using blood samples
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After 3 years
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合作者和调查者
调查人员
- 首席研究员:Won Sik Lee, Dr. PhD.、Inje University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BuEAM-DLBCL
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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非霍奇金淋巴瘤的临床试验
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Rutgers, The State University of New Jersey完全的