JPRN-jRCTs031180399招募中2 期
Single agent graft-versus-host disease prophylaxis with post-transplant cyclophosphamide for stem cell transplantation: a phase II study - SAP-P2
Sakaguchi Hirotoshi0 个研究点目标入组 30 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 20age old（—）
- 性别
- All
入选标准
- •1) Diagnosed as acute leukemia (acute lymphoblastic leukemia/acute myeloblastic leukemia), or lymphoma
- •2) First or second remission, and planned to have stem cell transplantation
- •3) Donor for transplantation is one of the follows;
- •a. HLA 6/6 (A, B, DR) matched related donor
- •b. HLA 5/6 (A, B, DR) matched related donor
- •c. HLA 6/6 (A, B, DR) matched unrelated donor
- •4) Age at transplantation <20 years
- •5) ECOG Performance status: 0-2
- •6) Sufficient organ function, as follows;
- •a. T-Bil <= 1.5 mg/dl
- •b. Serum creatinine <= 0.8 mg/dl (age <5y), <= 1.2 mg/dl (age 5-9y), <= 1.5 mg/dl (10y or older)
- •c. Ejection fraction 45% or better, and QTfc <0.45 sec
- •7) Obtained informed consent from a guardian of the patient if the patient is under 18 years of age, or from the patient if the patient is 18 years of age or older.
排除标准
- •1. Prior allogeneic stem cell transplantation
- •2. Effusion with grade 2 or worse at CTCAE ver 4.0
- •3. Uncontrolled infection
- •4. Severe psychological disorders
- •5. Pregnant or suspected pregnancy
- •6. Not eligible for this study at the discretion of the investigator.
研究者
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