EUCTR2006-006090-24-GB进行中（未招募）1 期
A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma - Bortezomib Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Confirmed diagnosis of mantle cell lymphoma
- •Refractory to, or relapse or progression following completion of first-line anti-neoplastic therapy
- •Measurable disease
- •Karnofsky Performance status >50% (ECOG 0-2)
- •Toxic effects from previous therapy or surgery to be resolved to Grade 2 or better
- •Absolute neutrophil count >1000 ells/ul (not related to lymphoma)
- •Platelets >30,000 cells/ul
- •AST <3xULN, ALT<3xULN
- •Total bilirubin <2ULN
- •Calculated creatinine clearance >20ml/min
- •All chemotherapy regimens are permissible +/- Rituximab
- •Prior splenectomy or localised RT is permissible
- •Male and female patients aged 18 years or older
- •Written informed consent prior to any study related procedures
- •Where appropriate, patients to agree to take adequate methods of contraception for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known serological positivity for HBV, HCV, HIV
- •Previous treatment with Velcade
- •Anti-neoplastic treatment within 3 weeks before Day 1 of cycle 1
- •Nitrosoureas within 6 weeks before Day 1 of cycle 1
- •Rituximab, alemtuzumab (Campath) or other unconjugated therapeutic antibody within 4 weeks before day 1 of Cycle 1
- •Radiation therapy within 3 weeks prior to Day 1 of Cycle 1
- •Major surgery within 2 weeks before Dat 1 of Cycle 1
- •History of allergic reaction attributable to compounds containing boron or mannitol
- •Female patients who may be pregnant or breast feeding
- •Active systemic infection requiring treatment
- •Diagnosed, or treated for, a malingancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous carcinoma of the skin, or any in-situ malignancy
- •Concurrent treatment with another investigational agent
- •Serious medical or psychiatric illness likely to interfere with participation in this study
研究者
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