NCT04886726招募中1 期
Post-transplant Cyclophosphamide and Urinary-derived Human Chorionic Gonadotropin and Epidermal Growth Factor (uhCG/EGF) as Graft Versus Host Disease Prophylaxis for Mismatched Unrelated Donor Transplantation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence and severity of dose limiting toxicity (DLTs)
研究概览
简要总结
So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
- •Age 18-70 years old
- •Performance score of at least 80% by Karnofsky
- •Adequate kidney and liver function as demonstrated by:
- •Creatinine clearance should be >60 ml/min
- •Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
- •Negative Beta HCG test in a woman with childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of childbearing potential must be willing to use an effective contraceptive measure while on study.
- •Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
排除标准
- •Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
- •Active or prior CNS leukemia, unless in complete remission for at least 2 months.
- •History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
- •Uncontrolled infection
- •Donor specific antibodies
- •Ejection fraction <40% or history of heart failure or cardiovascular disease
- •history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
- •Previous history hormone responsive cancer
- •history of seizure
- •history of migraine or severe headache
- •history of asthma
- •history of uterine fibroid
研究组 & 干预措施
PTCY and uhCG/EGF
Experimental
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
干预措施: uhCG/EGF (Drug)
结局指标
主要结局
Incidence and severity of dose limiting toxicity (DLTs)
时间窗: day+30 post SCT
The overall incidence and severity of DLTs for uhCG/EGF
MTD
时间窗: day+30 post SCT
The maximum tolerated dose
次要结局
- acute GVHD(till day +100 post SCT)
- Chronic GVHD(one year post SCT)
- Overall survival(one year post SCT)
- Disease free survival(one year)
研究者
Shatha Farhan
Clinical Assistant Professor
Henry Ford Health System
研究点 (1)
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