Dapagliflozin for Preventing Acute Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation: A Prospective, Single-Arm Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Cumulative incidence of grade II-IV aGVHD
研究概览
简要总结
The goal of this clinical trial is to learn if Dapagliflozin could prevent acute graft-versus-host disease (aGVHD) in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT) with haploidentical or unrelated donor and to assess its safety. The main questions it aims to answer are: Dose Dapagliflozin lower the cumulative incidence of aGVHD? What medical problems do participants undergoing allo-HCT from haploidentical or unrelated donor have when taking Dapagliflozin? Researchers will document the occurrence of graft-versus-host disease, hematopoietic reconstitution, survival rates and adverse effects. Participants will take Dapagliflozin every day in -1 to 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years old.
- •Patients with hematologic malignancies indicated for allo-HCT and having a suitable haploidentical or unrelated donor.
- •Willing to undergo myeloablative conditioning and graft-versus-host disease prophylaxis base on cyclosporin A and methotrexate.
- •With Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patients with prior use of Dapagliflozin or other hypoglycemic medications may switch to Dapagliflozin, contingent upon the treating physician's assessment of contraindications, will be eligible.
- •Signing an informed consent form, having the ability to comply with study and follow-up procedures.
排除标准
- •With other malignancies.
- •With a previous history of autologous hematopoietic cell transplantation, allo-HCT or chimeric antigen receptor T-cell therapy.
- •With a history of allergies to Dapagliflozin.
- •With type 1 diabetes or a history of ketoacidosis.
- •With a history of recurrent urinary tract infections.
- •With severe organ dysfunction.
- •With active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection.
- •In pregnancy or lactation period.
- •With any conditions not suitable for the trial (investigators' decision).
研究组 & 干预措施
Dapagliflozin arm
Participants will take Dapagliflozin10mg every day in -1 to 14 days.
干预措施: Dapagliflozin (DAPA) (Drug)
结局指标
主要结局
Cumulative incidence of grade II-IV aGVHD
时间窗: 100 days after transplantation.
estimated cumulative incidence of grade II-IV aGVHD at 100 days.
次要结局
- Platelet reconstitution(up to 100 days.)
- Cumulative incidence of relapse(1 year after transplantation.)
- Graft-versus-host disease-free relapse-free survival (GRFS)(1 year after transplantation.)
- Treatment related non-hematological grade 3 or higher adverse events(up to 100 days.)
- Cumulative incidence of grade III-IV aGVHD(100 days after transplantation.)
- Neutrophil reconstitution(up to 30 days.)
- Cumulative incidence of chronic graft-versus-host disease (cGVHD)(1 year after transplantation.)
- Overall survival(1 year after transplantation.)