Evaluation of the Clinical Outcome of Cyclosporine Short Infusion Versus Continuous Infusion Post Allogenic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Recording the occurrence of graft-versus-host disease (GvHD) events [Safety and tolerability]
研究概览
简要总结
This study focuses on the basis for current immunosuppressive strategies in patients undergoing allogeneic haematopoietic stem cell transplantation at the bone marrow transplantation unit in Ain Shams university hospitals. It discusses whether there is room for improving both the monitoring and the delivery of pharmacologically mediated immunosuppression in this population of patients. Our study will try to determine whether CsA administration at a daily dose of 3 mg/kg/day intravenously (IV) in 2 hrs (short infusion) twice-daily will achieve C2 blood levels of at least 800 mg/l and whether it will be feasible and safe or not.
详细描述
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) is considered as a curative treatment for patients with haematological malignancies like leukaemia, myelodysplasia, lymphoma, and multiple myeloma. However, graft-versus-host disease (GvHD) both in its acute and chronic forms, has limited the benefits of allogeneic HSCT by significant morbidity and mortality.
Pharmacological suppression of the donor-derived alloreactive immune response has played a central role in reducing the morbidity and mortality of graft-versus-host disease (GvHD), which remains the major cause of toxicity after allogeneic stem cell transplantation (SCT).
Graft versus host disease (GvHD) is a condition that might occur after an allogenic transplant, In GvHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. There are two forms of GvHD: Acute graft versus host disease (aGvHD) and Chronic graft versus host disease (cGvHD). As an allogeneic transplant recipient, the patient might experience either form of GvHD, both forms, or neither.
Acute GvHD, which results from an interaction of donor T lymphocytes with the recipient's antigens, occurs in approximately 30%-60% of patients after allogeneic Hematopoietic Stem Cell Transplantation (HSCT). At the same time, it has become clear that the intensity of post-transplant immunosuppression is one of the most important determinants of relapse risk through its impact on the potency of an immunologically mediated graft-versus leukaemia (GVL) effect.
Among the variety of immunosuppressants available, cyclosporin A (CsA) has been the most extensively used drug to prevent or treat graft-versus-host disease (GvHD) in hematopoietic stem cell transplant (HSCT) recipients, since its introduction in the 1970s. It has been shown that CsA is effective in preventing and controlling acute and chronic GvHD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult ages >18 years.
- •Patients undergoing allogeneic stem cell transplantation, matched or mismatched related donors.
- •Had never been exposed to cyclosporin before.
排除标准
- •Patients with a hypersensitivity to cyclosporin or to any of the ingredients of the formulation.
- •Patient with abnormal hepatic functions.
- •Patient with abnormal renal functions with elevated serum creatinine levels in excess of 220 mmol/l at study entry.
- •Patient receiving systemically active azoles within 2 weeks before Hematopoietic Stem Cell Transplantation (HSCT) patients.
- •Patient with body mass index (BMI) above 30 kg/m2.
研究组 & 干预措施
Group A
Cyclosporin of a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h
干预措施: Cyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h (Drug)
Group B
Administer cyclosporin daily dose of 3 mg/kg/day in a continuous infusion over 23 h every 24 h.
干预措施: Cyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h (Drug)
结局指标
主要结局
Recording the occurrence of graft-versus-host disease (GvHD) events [Safety and tolerability]
时间窗: Three months following transplantation date
To compare between the administration of twice-daily cyclosporin infusion over two hours versus continuous cyclosporin infusion via recording the occurrence of graft-versus-host disease (GvHD) events
Recording the occurrence of cyclosporine toxicity adverse events [Safety and tolerability]
时间窗: Three months following transplantation date
To compare between the administration of twice-daily cyclosporin infusion over two hours versus continuous cyclosporin infusion via recording the occurrence of cyclosporine toxicity adverse events
次要结局
- Correlation with the the area under the concentration-time curve in the first 4 hours after the drug administration (AUC0-4)(From Transplantation date till day 8 afterward)
- Recording the achievement of C2 (The drug concentration level determined 2 hours after the administration) blood levels of at least 800 mg/l. [Efficacy](From Transplantation date till 3 months afterward)
研究者
Shaymaa Mohammed El-Awady
Principal Investigator
Ain Shams University