Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- Rate of decrease of acute GVHD grade
研究概览
简要总结
The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates. Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them, investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication, Zenapax, will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD.
Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient with kidney transplant to help prevent graft rejection. This medication has been used in bone marrow transplant patients to treat GVHD.
详细描述
GVHD occurs when the donor's immune system recognizes a patient's body as foreign and reacts against it. GVHD may result in skin rashes and blistering, liver inflammation and gastrointestinal problems including nausea, vomiting, diarrhea and bleeding. Mild GVHD may be treated with topical medications applied to the skin. More severe GVHD requires medications given intravenously (by vein) or taken by mouth. Steroids are usually given first to treat GVHD but only 40% of people respond to this alone.
OBJECTIVES:
- Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
- Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
- Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
- Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100.
- Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daclizumab
Patients are randomized to 1 of 2 treatment arms.
Arm I:
- Patients receive methylprednisolone or equivalent corticosteroid IV or orally
- Daclizumab IV on days 0, 3, 7, 14, and then weekly as indicated until day 100.
Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.
Patients are followed at 1 year and then annually thereafter.
干预措施: Daclizumab (Biological)
Daclizumab
Patients are randomized to 1 of 2 treatment arms.
Arm I:
- Patients receive methylprednisolone or equivalent corticosteroid IV or orally
- Daclizumab IV on days 0, 3, 7, 14, and then weekly as indicated until day 100.
Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.
Patients are followed at 1 year and then annually thereafter.
干预措施: methylprednisolone (Drug)
Placebo
Patients are randomized to 1 of 2 treatment arms.
- Patients receive methylprednisolone or equivalent corticosteroid as in Daclizumab arm
- Placebo IV on days 0, 3, 7, 14, and then weekly as indicated until day 100.
干预措施: methylprednisolone (Drug)
Placebo
Patients are randomized to 1 of 2 treatment arms.
- Patients receive methylprednisolone or equivalent corticosteroid as in Daclizumab arm
- Placebo IV on days 0, 3, 7, 14, and then weekly as indicated until day 100.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of decrease of acute GVHD grade
时间窗: Day 42
次要结局
- Total Steroid Dose(100 Days)
- Overall Survival(100 Days)
- Relapse Rate(1 Years)
- Number of Hospitalized Days(100 Days)
- 100 Day Mortality(100 Day)
- Complete Response of GVHD(100 Days)
- Number of Participants with Steroid related Complication(1 Year)
- Total Days of Antibiotic or Antifungal(100 Days)
研究者
Vincent T. Ho, MD
VIncent T. Ho, MD
Dana-Farber Cancer Institute