NCT03465527已完成2 期
A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- (treatment-related mortality rate; TRM)
研究概览
简要总结
A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL
详细描述
R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically the first large-scaled B-cell lymphoma patient
- •Diagnosis time 65 years old or older
- •Patients planning R-CHOP chemotherapy
- •Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4
- •The International Prognostic Index (IPI) is a high intermediate or high risk
- •Patients without prior history of lymphoma
- •The decision to participate voluntarily in this study and the written consent of the patient
排除标准
- •Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma
- •Large B-cell lymphoma involving the central nervous system
- •Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials
- •If the drug used in this study is allergic
- •If you do not agree to participate in the study
研究组 & 干预措施
Prednisolone
Experimental
Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days
Hydration, antibiotics, allopurinol, nutritional supplements, and so on.
干预措施: PrednisoLONE 50 MG (Drug)
结局指标
主要结局
(treatment-related mortality rate; TRM)
时间窗: an average of 1 year
treatment-related mortality rate
次要结局
- IMWG fragility score before and after pre-phase treatment(an average of 1 year)
- TRM and RR according to IMWG fragility score(an average of 1 year)
- response rate; RR(an average of 1 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(an average of 1 year)
- Incidence of neutropenic fever(an average of 1 year)
研究者
Ho Sup Lee
MD, PhD. associate professor, Division of hematology-Oncology
Kosin University Gospel Hospital
研究点 (1)
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