NCT00806208已完成1 期
Phase I Evaluation of Safety, Pharmacokinetics and Activity of Escalating Dose Levels of MEDI 507 in Patients Receiving Methylprednisolone for Initial Treatment of at Least Grade II 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
- 34
- 试验地点
- 3
- 主要终点
- Safety; first infusion of study drug
研究概览
简要总结
A trial to assess safety of four doses of MEDI 507 combined with another drug for initial treatment of at least Grade II acute Graft-vs-Host Disease in recipients.
详细描述
The primary objective of this study is to assess safety of four dose levels of MEDI 507 combined with methylprednisolone for initial treatment of at least Grade II acute GvHD in stem cell or bone marrow allograft recipients.
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
- •receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug
- •evidence of engraftment (ANC over 1,000 cells/mm3)
- •histologic evidence of GvHD from biopsy performed during the current episode
- •receipt of 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, unless previously surgically sterilized, agree to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant7 or DepoProvera7) beginning with the first study injection and continuing through 60 days after the final study injection.
排除标准
- •previous receipt of MEDI 507
- •diagnosis of chronic GvHD
- •previous treatment with any anti-T-cell monoclonal antibodies such as OKT73 or daclizumab (Zenapax7)
- •receipt of antithymocyte globulin (ATGAM7 or other ATG) within 14 days
- •treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of GvHD
- •intolerance or history of intolerance to corticosteroids such that it is unlikely the patient will be able to complete at least ten days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or equivalent)
- •more than one allogeneic bone marrow or hematopoietic stem cell allograft
研究组 & 干预措施
1
Active Comparator
MEDI 507 and Methylprednisolone
干预措施: MEDI-507 (Drug)
2
Active Comparator
MEDI-507 and Methylprednisolone
干预措施: MEDI-507 (Drug)
3
Active Comparator
MEDI-507 and Methylprednisolone
干预措施: MEDI-507 (Drug)
4
Active Comparator
MEDI-507 and Methylprednisolone
干预措施: MEDI-507 (Drug)
5
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety; first infusion of study drug
时间窗: Through Study Day 44
次要结局
未报告次要终点
研究者
研究点 (3)
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