ISRCTN20159589已完成2 期
A parallel randomised phase II trial of cyclophosphamide, adriamycin, vincristine and prednisolone (CHOP) chemotherapy with or without Bortezomib in relapsed mantle cell lymphoma
Plymouth Hospitals NHS Trust (UK)0 个研究点目标入组 90 人开始时间: 2008年5月16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
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female subjects 18 years and older
- •2. A confirmed diagnosis of MCL including expression of cyclin D1 or evidence of t(11;14), such as by cytogenetics, fluorescent in situ hybridisation (FISH) or polymerase chain reaction (PCR)
- •3. Refractory to, or relapse, or progression following completion of first line anti-neoplastic therapy
- •4. All chemotherapy regimens are permissible and can be given in combination with rituximab
- •5. Prior splenectomy or localised radiotherapy is permissible
- •6. Measurable disease
- •7. Karnofsky Performance Status (KPS) greater than 50% (Eastern Cooperative Oncology Group [ECOG] grade 0 - 2)
- •8. Absolute neutrophil count greater than 1000 cells/mcg not related to lymphoma
- •9. Platelets greater than 30,000 cells/mcg
- •10. Aspartate transaminase less than 3 x upper limit of normal (ULN), alanine transaminase less than 3 x ULN, total bilirubin less than 2 x ULN, and calculated creatinine clearance greater than 20 mL/min
- •11. Toxic effects of previous therapy or surgery resolved to grade 2 or better
- •12. Female subject is either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control
- •13. Male subject agrees to use an acceptable method for contraception for the duration of the study
- •14. 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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. Previous treatment with Velcade®
- •3. Anti-neoplastic therapy within three weeks before day 1 of cycle 1
- •4. Nitrosoureas within six weeks before day 1 of cycle 1
- •5. Rituximab, alemtuzumab (Campath®) or other unconjugated therapeutic antibody within four weeks before day 1 of cycle 1
- •6. Radiation therapy within three weeks before day 1 of cycle 1
- •7. Major surgery within two weeks before day 1 of cycle 1
- •8. History of allergic reaction attributable to compounds containing boron or mannitol
- •9. Diagnosed or treated for a malignancy other than MCL within five years before day 1 of cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or any in situ malignancy
- •10. Active systemic infection requiring treatment
- •11. Female subject is pregnant or breast-feeding. 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 sterilised women.
- •12. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •13. Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it does not interfere with participation in this study.
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