EUCTR2009-017675-16-GB进行中（未招募）1 期
Phase II Trial of Single Agent Ofatumumab in Relapsed / Refractory Mantle Cell Lymphoma - Ofatumumab Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
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
- •Male or female patients over the age of 18 years
- •A confirmed diagnosis of MCL including expression of cyclin D1 or evidence of t (11; 14), by cytogenetics, fluorescent in situ hybridisation (FISH) or polymerase chain reaction (PCR)
- •Relapse/refractory MCL following the completion of a minimum of one previous course of cytotoxic chemotherapy treatment.
- •All previous chemotherapy regimens are permissible (including Rituximab)
- •Measurable disease
- •Karnofsky Performance Status (KPS) ?50% (ECOG 0-2)
- •Absolute neutrophil count ? 500 cells/?L not related to lymphoma
- •Platelets ?30,000 cells/?L not related to lymphoma
- •Toxic effects of previous therapy (with the exception of any haematological toxicities as above) or surgery resolved to Grade 2 or better
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •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 or HIV
- •Anti-neoplastic therapy within 3 weeks before Day 1
- •Nitrosoureas within 6 weeks before Day 1
- •Radiation therapy within 3 weeks before Day 1
- •Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within 4 weeks before Day 1
- •Major surgery within 2 weeks before Day 1
- •Active systemic infection requiring treatment
- •Previous treatment or suspected hypersensitivity to Ofatumumab
- •Any concurrent active malignancy within the last 5 years
- •Aspartate transaminase >3.0 x upper limit of normal (ULN), or alanine transaminase >3.0 x ULN unless due to liver involvement with MCL
- •alkaline phosphatase >3.0 x ULN
- •total bilirubin >2.0 x ULN unless due to liver involvement with MCL
- •serum creatinine > 2.0 x ULN (unless normal creatinine clearance)
- •Female subject is pregnant or breast-feeding; confirmation of this will be required for female patients of child-bearing potential.
- •Moderate or severe Chronic Obstructive Pulmonary Disease
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study
- •Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert’s syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease. Patients with these conditions may be included subject to PI assessment)
研究者
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终止
2 期
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