NCT00636311已完成2 期
IGEV +/- Bortezomib (Velcade) as Induction Before High Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma After First Line Treatment: a Randomized Phase II Trial. On Behalf of Intergruppo Italiano Linfomi
Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- PET negativity rate obtained with IGEV or B-IGEV will be compared
研究概览
简要总结
The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at transplantation.
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
- •Diagnosis of Hodgkin's lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
- •Age >18 and <65 years
- •Signed informed consent
- •If female, patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control
- •If male, patient agrees to use an acceptable barrier method for contraception
- •ECOG performance status <2
- •Platelet count >100.000/mmc
- •Hemoglobin >7.5 g/dL
- •Absolute neutrophil count (ANC) >1.500/mmc
- •Serum calcium <3.5 mmol/L (<14 mg/dL)
- •AST/ALT: <2.5 x the ULN
- •Total bilirubin: <1.5 x the ULN
排除标准
- •Previous treatment with velcade
- •Nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment
- •Immunotherapy or antibody therapy within 4 weeks before enrollment
- •Experimental drug or medical device within 4 weeks before start of treatment
- •Major surgery within 4 weeks before enrollment
- •History of allergic reaction attributable to compounds containing boron or mannitol or any of the drugs in the IGEV regimen
- •Peripheral neuropathy of NCI CTCAE Grade 2 or higher
- •Myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
- •Need for therapy with concomitant CYP 3A4 inhibitors or inducers
- •HIV-positive, if known
- •Hepatitis B surface antigen-positive or active hepatitis C infection, if known
- •Active systemic infection requiring treatment
- •If female, pregnancy or breast-feeding.
研究组 & 干预措施
1
Active Comparator
IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
干预措施: Ifosfamide, Gemcitabine, Vinorelbine (Drug)
2
Experimental
B-IGEV (Bortezomib + IGEV)
干预措施: Bortezomib + IGEV (Drug)
结局指标
主要结局
PET negativity rate obtained with IGEV or B-IGEV will be compared
时间窗: PET negativity after 4 courses of induction (IGEV or B-IGEV)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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