KCT0003987招募中未知
Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 59
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Newly histologically confirmed CD20 positive diffuse large B-cell lymphomas and only Non-GCB type will be included
- •2.High intermediate or high risk by IPI risk, or Bulky mass = 10cm at diagnosis
- •3.Complete response is confirmed after six or eight cycles R-CHOP chemotherapy by CT scan with confirmed negative PET-CT based on the Revised International Workshop Criteria.
- •4.Additional surgery or radiotherapy are accepted
- •5.Age = 20
- •6.Performance status (ECOG) = 2
- •7.Adeqaute renal function: Cr < 2.5 mg/dL
- •8.Adeqaute liver functions:
- •Transaminase (AST/ALT) < 3 x upper normal value (UNV)
- •Bilirubin < 1.5 x UNV
- •Alkaline phosphatase < 5 xUNV
- •9.Adeqaute BM functions:
- •ANC > 1,000/uL and platelet > 75,000/uL and
- •Hemoglobin > 9.0 g/dL
- •10.Written Informed consent
排除标准
- •1.Tumor response after 6-8 cycles CTx< CR
- •2.Consider stem cell transplantation
- •3.Central nervous system (CNS) metastases
- •4.Pregnant or lactating women, patients of childbearing potential not employing adequate contraception
- •5.Other serious illness or medical conditions
- •A.Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •B.History of significant neurologic or psychiatric disorders including dementia or seizures
- •C.Active uncontrolled infection
- •6.Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri.
- •7.Prior history of allergic reaction to study treatment drugs
- •8.Peripheral neuropathy grade 2 or worse
- •9.DLBCL of the testis and primary mediastinal DLBC
研究者
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