Newly Diagnosed Waldenström's Macroglobulinemia
赞助:
Kosin University Gospel Hospital
合作者:
信息的提供 (责任方):
Ho Sup Lee，Kosin University Gospel Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | October 31, 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
survival[ Time Frame: 2 years ] Response assessment in Waldenström macroglobulinaemia |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Newly Diagnosed Waldenström's Macroglobulinemia | ||
| 正式标题 ICMJE | A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia | ||
| 简要概况 | A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial) |
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| 详细说明 | Most patients with Waldenstrom's Macroglobulinemia are rare, and most studies are based on Phase II clinical studies, so the most effective regimen has not been established. However, in patients without experience of treatment with rituximab monotherapy targeting CD20 antigen expressed on lymphocytic cells, the response rate is reported to be approximately 25% -45%. Combined chemotherapy including rituximab is recommended as a primary treatment. In Korea, there are few studies on Waldenstrom's Macroglobulinemia, and a relatively large number of patients have studied the data of 71 patients in 2014, retrospectively. In the present study, we found that the combined chemotherapy regimen with rituximab significantly improved the overall response rates. Bortezomib may also be effective in the treatment of Waldenstrom's Macroglobulinemia. Based on this, clinical trials of combined chemotherapy with rituximab or dexamethasone have been conducted and 80-90% reported However, lenalidomide 15mg alone was administered, lenalidomide was effective in Waldenstrom's Macroglobulinemia with a 29% overall response rate. The authors concluded that the combination therapy of rituximab, bortezomib, lenalidomide, and dexamethasone is an effective treatment regimen that can improve the overall response rate including complete remission. Patients with Waldenstrom's Macroglobulinemia diagnosed in Korea we planned this study to evaluate the efficacy and safety of lenalidomide maintenance therapy with chemotherapy with chemotherapy including rituximab, bortezomib, lenalidomide, and dexamethasone | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
54 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 31, 2023 | ||
| 预计主要完成日期 | October 31, 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 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. Exclusion Criteria: 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 | ||
| 性别 |
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| 年龄 | 最小年龄：19 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Ho Sup Lee，Kosin University Gospel Hospital | ||
| 研究赞助商 ICMJE | Kosin University Gospel Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Kosin University Gospel Hospital | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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