NCT00813618已完成1 期
Phase I Study of MEDI 507 in the Treatment of Pediatric Patients With at Least Grade II Acute Graft-Versus-Host Disease (GvHD)
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
- 10
- 试验地点
- 6
- 主要终点
- Safety assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD).
研究概览
简要总结
To assess the safety of escalating dose levels of MEDI-507 in pediatric stem cell and bone marrow allograft recipients who have at least Grade II GvHD.
详细描述
This is a Phase I, open-label dose escalation trial of MEDI-507 in pediatric SCT and BMT recipients with at least Grade II acute GvHD. All patients will receive steroid therapy and MEDI-507 for treatment of GvHD
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic BMT or SCT recipients
- •Acute GvHD of at least Grade II severity
- •Age 2 to 17 years
- •Evidence of engraftment (ANC over 500 cells/mm3 on two consecutive days within seven days before study entry)
- •Receipt of GvHD prophylaxis regimen including methotrexate, tacrolimus or cyclosporine
- •Receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) between eight and 24 hours prior to the first MEDI-507 dose for GvHD treatment
- •Both males and females are eligible, but sexually active females at risk of pregnancy of childbearing potential must agree to use an effective method of avoiding pregnancy (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) beginning 30 days before the first study infusion and continuing through 60 days after the final study infusion.
排除标准
- •Treatment of acute GvHD with methylprednisolone (or equivalent corticosteroid) at a total dose exceeding 14 mg/kg (or equivalent) over a seven day period (for example, 2 mg/kg/day for seven days)
- •Previous receipt of MEDI 507
- •Previous treatment with any anti-T cell monoclonal antibodies, such as OKT3, daclizumab (Zenapax), or basiliximab (Simulect)
- •Treatment with anti-thymocyte globulin (ATG, ATGAM or others) within 14 days
- •More than one allogeneic bone marrow or hematopoietic stem cell allograft
- •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) or current participation in a research protocol in which an investigational agent was administered
- •Any of the following clinical settings or diagnoses:
- •documented or presumed significant active infection
- •pregnancy or nursing mother
- •evidence of infection with HIV-1, hepatitis B or C virus
- •hemodialysis or chronic peritoneal dialysis
- •use of a ventilator
- •chronic GvHD
- •active veno-occlusive disease of the liver
- •moribund patient
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)
3
Experimental
MEDI-507
干预措施: MEDI-507 (Drug)
结局指标
主要结局
Safety assessment of escalating dose levels of MEDI-507 in pediatric stell scell (SCT) and bone marrow (BMT) allograft recipients who have at least Grade II Graft-versus-Host Disease (GvHD).
时间窗: Through Study Day 44
次要结局
- Evaluate the serum concentrations and pharmacokinetics (PK) of MEDI 507 and pharmacodynamic effects of MEDI-507 on the absolute lymphocyte count and dynamics of lymphocyte phenotypes.(Through Study Day 364)
研究者
研究点 (6)
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