NCT05509933招募中3 期
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- non-infectious fever
研究概览
简要总结
The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients 18-80 years of age with a diagnosis of a hematological malignancy
- •Meet the BMT program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies
排除标准
- •• Patients enrolled in investigational clinical trials
- •Sct for non hematologic malignancies
研究组 & 干预措施
nothing
No Intervention
Budesonide
Experimental
干预措施: Budesonide (Drug)
结局指标
主要结局
non-infectious fever
时间窗: 30 days post stem cell transplant
non infectious fever defined as fever without identified infection that occurs up to 3 days prior and 10 days after the day of engraftment in patients on budesonide prophylaxis compared to patients who will not receive prophylaxis
次要结局
未报告次要终点
研究者
Shatha Farhan
MD
Henry Ford Health System
研究点 (1)
Loading locations...
相似试验
终止
2 期
Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and EverolimusGraft vs Host DiseaseNCT00117702Technische Universität Dresden24
已完成
4 期
Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLVLung CancerNCT03394222Fujian Medical University Union Hospital50
已完成
3 期
Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell TransplantationGraft-Versus-Host DiseaseLeukemiaNCT00180089Technische Universität Dresden242
已完成
4 期
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)Myelodysplastic SyndromesMyeloproliferative DisordersLeukemia, LymphocyticMyelomaLymphomaNCT00361140H. Lee Moffitt Cancer Center and Research Institute72
终止
4 期
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy BleedingAdenomaNCT02032784AdventHealth33