2024-518738-97-00招募中2 期
Role of Vitamin D in GVHD prophylaxis in patients undergoing allogeneic transplantation stem cells. Pilot phase II study randomized open monocentric
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reducing the severity of GVHD
研究概览
简要总结
Evaluation of the effectiveness of vitamin D on the degree si severity of acute and chronic GvHD
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged > 18 years. Male and female - Diagnosis of any oncohematologic disease with transplant indication, also allowed patients not in clinical response - Patients undergoing allogeneic stem cell transplantation regardless of conditioning regimen and HSC source - Ability to sign informed consent
排除标准
- •Transplantation from T-depleted or T-selected product; - Documented intolerance to the drug or any of its excipients; - Ongoing vitamin D therapy for any medical condition; -Hypercalcemia, hypercalciuria, kidney stones, renal failure; - Age < 18 years - Subjects who are not deemed legally capable of consent. - In the case of female: sex pregnancy and/or lactation.
结局指标
主要结局
Reducing the severity of GVHD
Reducing the severity of GVHD
次要结局
- - Evaluation of circulating lymphocyte subpopulations on peripheral blood - Assessment of vitamin D receptor (VDR) surface expression and modulation in response to vitamin D treatment on lymphocyte subpopulations. - Evaluation of the soluble fraction of VDR on serum - post hoc evaluation of the role of polymorphisms (SNPs) of recipient and donor VDR on response to vitamin D therapy - collection of any adverse events brought about by cholecalciferol intake
研究者
Clinical Trial Center
Scientific
Azienda Ospedaliero Universitaria Pisana
研究点 (1)
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