NCT00210392终止2 期
Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-Cell Lymphoma of MALT-Type Pretreated With More Than One Prior Systemic Therapy Regimen (X05142)
International Extranodal Lymphoma Study Group (IELSG)2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses
研究概览
简要总结
The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses) of bortezomib in pretreated MALT lymphomas with more than one prior systemic therapy regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven diagnosis of marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
- •any stage (Ann Arbor I-IV)
- •relapsed or refractory disease pretreated with > 1 prior chemotherapy regimen and/or anti-CD20 immunotherapy
- •no evidence of histologic transformation to a high grade lymphoma
- •measurable or evaluable disease
- •age > 18 years
- •full recovery from previous therapy, with life expectancy of at least 6 months
- •ECOG performance status 0-2
- •for primary gastric localized H. pylori-positive disease at diagnosis:
- •persistent disease 1 year after documented H. pylori infection eradication
- •clinical, endoscopic (or histologic) evidence of progression at any time after H. pylori infection eradication
- •no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks
- •no corticosteroids during the last 4 weeks, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
- •adequate renal function (calculated or measured creatinine clearance >30 mL/minute), liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal) and bone marrow function
- •no evidence of active opportunistic infections
- •no known HIV infection
- •no active HBV and/or HCV infection
- •no serious medical illness likely to interfere with participation in this clinical study
- •voluntary written informed consent before performance of any study-related procedure
- •female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study
排除标准
- •prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type
- •(CIN1) or localized non-melanomatous skin cancer
- •other investigational drugs with 14 days before enrollment
- •evidence of symptomatic central nervous system (CNS) disease
- •severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14 days before enrollment), unless due to lymphoma involvement
- •evidence of ≥ grade 2 peripheral neuropathy within 14 days before enrollment
- •known hypersensitivity to bortezomib, boron or mannitol
- •pregnant or lactating status, confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women
- •any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
结局指标
主要结局
Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses
时间窗: During treatment and one month after treatment completion
次要结局
- Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients(18 months after study completion)
- Safety, as acute and long-term toxicity(18 months after treatment completion)
- Response duration (RD) (time to relapse or progression) in responders(18 months after treatment completion)
研究者
研究点 (2)
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