KCT0003255招募中未知
A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with Waldenström´s macroglobulinemia
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia
- •2. Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia
- •3. Male or female patients aged =19 years
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •5. Patients must have measurable disease, IgM > 0.5g/dL
- •6. Appropriate bone marrow, liver, and kidney function
- •7. Patients who are able to understand oral and written instructions and who are able to comply with all requirements
- •8. Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial.
- •9. Female patients had to be post-menopausal for =1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for =6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.
排除标准
- •1. Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia
- •2. Patients who have received rituximab, lenalidomide, or bortezomib
- •3. Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib
- •4. One of the following labs or more:
- •? Absolute neutrophil count (ANC) <1,000 / µL
- •? Platelet count <75,000 cells / µL when not transfused
- •? Serum AST / ALT> 3 times the upper limit of normal
- •5. Renal failure requiring hemodialysis or peritoneal dialysis
- •6. Patients with uncontrolled severe heart disease
- •7. Patients who can not or do not want antithrombotic therapy
- •8. Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period
- •9. Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF
- •10. Patients who have been diagnosed with a currently unadjusted severe infection
- •11. Patients with known human immunodeficiency virus (HIV), hepatitis C infection
- •12. Patients diagnosed with malignancy within 5 years before signing ICF
- •13. Pregnant or lactating patients
- •14. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
- •15. Patients with acute diffuse invasive pulmonary disease and cardiovascular disease
研究者
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