NCT00806728已完成1 期
Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
研究概览
简要总结
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
详细描述
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic bone marrow or hematopoietic stem cell graft recipients
- •Acute GVHD of at least grade II severity
- •Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
- •Evidence of engraftment (ANC over 1000 cells/mm3)
- •Histologic evidence of GVHD from biopsy performed during the current episode
- •Received GVHD prophylaxis of methotrexate, tacrolimus or cyclosporine
- •Age at least 18 years
- •Body weight under 130 kg
- •Both males and females are eligible but females of childbearing potential will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)
排除标准
- •Previous receipt of MEDI-507
- •Clinical or histologic manifestation of chronic GVHD
- •Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
- •Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
- •More than one allogeneic bone marrow or hematopoietic stem cell allograft
- •Moribund and unlikely (in the opinion of the investigator) to survive 15 days
- •Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert)
- •Any of the following clinical settings or diagnoses:
- •Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
- •Histologically confirmed veno-occlusive disease of the liver
- •Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)
研究组 & 干预措施
1
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
2
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
结局指标
主要结局
Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
时间窗: Day 0-60
次要结局
- Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics(Study Days 12 and 44)
研究者
研究点 (10)
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