ISRCTN32524443已完成2 期
Multicentre non-randomised interventional treatment phase II trial of single agent ofatumumab in relapsed/refractory mantle cell lymphoma
Plymouth Hospitals NHS Trust (UK)0 个研究点目标入组 12 人开始时间: 2011年2月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24666179 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients over the age of 18 years
- •2. 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)
- •3. Relapse/refractory MCL following the completion of a minimum of one previous course of cytotoxic chemotherapy treatment
- •4. All previous chemotherapy regimens are permissible (including those containing Rituximab)
- •5. Measurable disease
- •6. World Health Organization (WHO) score of 0 - 2
- •7. Absolute neutrophil count greater than or equal to 500 cells/µL not related to lymphoma
- •8. Platelets greater than or equal to 30,000 cells/µL not related to lymphoma
- •9. Toxic effects of previous therapy or surgery resolved to Grade 2 or better (with the exception of the haematological parameters discussed above)
- •10. 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
排除标准
- •1. Known serological positivity for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- •2. Anti-neoplastic therapy within 3 weeks before Day 1
- •3. Nitrosoureas within 6 weeks before Day 1
- •4. Radiation therapy within 3 weeks before Day 1
- •5. Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within three months before Day 1
- •6. Major surgery within 2 weeks before Day 1
- •7. Active systemic infection requiring treatment
- •8. Previous treatment or suspected hypersensitivity to Ofatumumab
- •9. Any concurrent active malignancy within the last 5 years ? patients who have a history of completely resected Non-melanoma skin cancer or in-situ carcinoma are eligible
- •10. Aspartate transaminase greater than 2.5 x upper limit of normal (ULN), or alanine transaminase greater than 2.5 x ULN, alkaline phosphatase greater than 2.5 x ULN unless due to disease involvement of the liver or bone
- •11. Total bilirubin greater than 1.5 x ULN unless due to liver involvement with MCL or known history of Gilbert's disease
- •12. Serum creatinine greater than 2.0 x ULN (unless normal creatinine clearance)
- •13. Female subject is pregnant or breast-feeding; confirmation of this will be required for female patients of child-bearing potential. For the purpose of this study, female of child-bearing potential is defined as women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
- •14. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
- •15. Moderate or severe Chronic Obstructive Pulmonary Disease
- •16. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •17. Treatment with another investigational agent for at least four weeks prior to enrolment into this study. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study.
- •18. 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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