jRCTs011190009已完成不适用
A phase II study of posttransplantation cyclophosphamide in patients undergoing HLA 6-8/8 match transplantation (JSCT PTCY19)
未提供0 个研究点目标入组 44 人开始时间: 2020年3月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 65age old under（—）
- 性别
- All
入选标准
- •1.Patients who have hematologic malignancies as defined at least one of the following:
- •a) Acute Leukemia: CR
- •b) Myelodysplastic syndrome: intermediate-II, high as defined by IPSS, or high, very high as defined by WPSS
- •c) Lymphoma: CR or chemosensitive PR
- •2.Age: 20-65 years old.
- •3.Patients who have HLA 6-8/8 matched related or unrelated peripheral blood stem cell donor
- •4.Performance status: 0-2
- •5.Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary).
- •6.Patients who give written informed consent to participate in the study.
排除标准
- •Patients with active other malignancies or patients with a history of malignancies within 5 years
- •Patients with active infectious disease.
- •Women who are pregnant or lactating
- •Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide, tacrolimus, mycophenolate mofetil.
- •Patients who have positive anti-donor HLA antibody.
- •Patients who are not eligible for this study at the discretion of the investigator.
结局指标
主要结局
-
The incidence of grade III-IV acute GVHD at 100 days
次要结局
- Engraftment(100 days)
- Overall survival(100 days, 1 year, and 2 years)
- Incidence of infectious event(100 days, 1 year, and 2 years)
- Incidence of acute GVHD and chronic GVHD(100 days, 1 year, and 2 years)
- Incidence of relapse(100 days, 1 year, and 2 years)
- Non-relapse mortality(100 days, 1 year, and 2 years)
- Proportion of patients who stopped immunosuppressive drugs(1 year and 2 year)
- Noninfectious fever(7 days after transplantation)
- Disease-free survival(100 days, 1 year, and 2 years)
- GVHD free, relapse free survival (GRFS)(100 days, 1 year, and 2 years)
- Grade 3-4 non-hematologic toxicity(100 days)
- Subgroup analysis according to conditioning regimen
- Subgroup analysis according to disease risk index (DRI)
研究者
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