IRCT20140818018842N31招募中2 期
Assessment of the Efficacy of High-Dose Intravenous Vitamin C on Severity of Acute Graft Versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation: A Randomized, Triple-Blind, Placebo-Control Trial
Research Institute for Oncology, Hematology and Cell Therapy0 个研究点目标入组 260 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 260
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
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Allogeneic hematopoietic stem cells transplantation due to any of the following hematological malignancies: Acute lymphoblastic leukemia (ALL)/ Acute myelogenous leukemia (AML)/ Myelodysplasia (MDS)/ Hodgkin's lymphoma (HL)/ non-Hodgkin's lymphoma (NHL)
- •Patient age = 18
- •Patients must also receive a full myeloablative conditioning regimen
- •HLA-full-matched stem cell donor, either related or unrelated from peripheral blood stem cell or bone marrow
- •Estimated creatinine clearance =60 ml/min
- •Serum total bilirubin = 2 x upper limit of normal value (ULN) and AST and ALT = 2 x ULN
- •Karnofsky Performance Status of 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status =2
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Known allergy to vitamin C
- •G6PDH deficiency
- •Patients with hemochromatosis
- •History of kidney stones or oxaluria during the last 5 years
- •Uncontrolled viral, fungal, or bacterial infection
- •Allogeneic or autologous hematopoietic stem cells transplantation in the past 12 monthsPregnancy or breastfeeding
- •Left ventricular ejection fraction < 40%
- •Patient participation in another similar research project simultaneously
- •Pregnancy or breastfeeding
研究者
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