A Randomized Study to Evaluate The Efficacy of Mycophenolate Mofetil Added to The Systemic Immunosuppressive Regimen First Used For Treatment of Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 151
- 试验地点
- 16
- 主要终点
- Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy
研究概览
简要总结
RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell transplantation. It is not yet known whether immunosuppressive treatment regimens are more effective with or without mycophenolate mofetil in treating chronic graft-versus-host disease.
PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease.
详细描述
OBJECTIVES:
- Compare the efficacy of immunosuppressive treatment regimens with vs without mycophenolate mofetil in patients with newly diagnosed chronic graft-vs-host disease.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, prospective, multicenter study. Patients are stratified according to organ involvement of chronic graft-versus-host disease (GVHD) (single organ vs multiple organs) and transplant center. Patients are randomized to 1 of 2 treatment arms.
All patients receive usual therapy for chronic GVHD comprising oral prednisone twice daily and oral cyclosporine, oral tacrolimus or oral sirolimus twice daily until 2 weeks after the first evidence of improvement of symptoms of chronic GVHD.
- Arm I: Patients receive oral mycophenolate mofetil twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms administration of the study drug continues for 3 months after completion of prednisone and cyclosporine, tacrolimus or sirolimus in the absence of disease progression or unacceptable toxicity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 —（Child, 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
Mycophenolate mofetil
Patients receive oral mycophenolate mofetil twice daily.
干预措施: mycophenolate mofetil (Drug)
Placebo
Patients receive oral placebo twice daily
干预措施: placebo (Drug)
结局指标
主要结局
Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy
时间窗: 2 years
Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy
次要结局
- Definitive Absence of Efficacy Success(2 years)
- Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy(2 years)
- Bronchiolitis Obliterans(within 4 years)
- Recurrent Malignancy(within 4 years)
- Non-relapse Mortality(within 4 years)
- Death or Recurrent Malignancy(within 4 years)
- Death(within 4 years)
- Withdrawal of Prednisone(within 4 years)
- End of Systemic Treatment(within 4 years)
研究者
Martin, Paul
Member
Fred Hutchinson Cancer Center