The Safety and Efficacy of Carfilzomib -a Novel Proteasome Inhibitor- for the Prevention of Acute Graft Versus Host Disease
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- incidence of acute graft-versus host disease
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel biological agent used in the treatment of multiple myeloma in preventing graft-versus-host disease, after stem cells transplantation from unrelated donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MDS/AML
- •18 years or older and willing and able to comply with the protocol requirements.
- •LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
- •Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation
- •Patients conditioned with reduced intensity or reduced toxicity conditioning i.e. Fludarabine combine with Treosulfan or 2-4 days of I.V Busulfan.
- •Patients must sign written informed consent.
- •Adequate birth control in fertile patients.
排除标准
- •Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.
- •Patients with respiratory failure (DLCO < 30%).
- •Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
- •Patients with > grade II liver renal toxicity.
- •Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
- •Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- •Creatinine > 2.0 mg/dl
- •ECOG-Performance status > 2
- •Uncontrolled infection
- •Pregnancy or lactation
- •CNS disease involvement
- •Pleural effusion or ascites > 1 liter.
研究组 & 干预措施
carfilzumib
Carfilzomib at a dose of 20mg/m2 I.V. will be administrated at day 1, 2 post infusion of the stem cell (SC) graft to the first 10 patients. If no > grade II toxicity* the next 10 patients will receive Carfilzomib (27 mg/m2) at day 1,2 and 8, 9, 15 and 16. If no > grade II toxicity* the next 10 patients will receive 2-3 cycles of Carfilzomib (27 mg/m2) administered at day 1,2 8,9,15 and 16 post SC graft infusion.
干预措施: carfilzumib (Drug)
结局指标
主要结局
incidence of acute graft-versus host disease
时间窗: 3 months
We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA.
次要结局
- incidence of chronic graft-versus-host disease(1 year)
- survival rate(2 years)