Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Feasibility of Enrolling Patients
研究概览
简要总结
This randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. Continuation of immunosuppressive treatment may prevent graft-versus-host disease worsening.
详细描述
PRIMARY OBJECTIVE:
I. Assess feasibility of enrolling and randomizing patients with chronic graft versus host disease (GVHD) to discontinuation (standard of care) versus continuation (investigation) of immunosuppressive therapy (IST).
SECONDARY OBJECTIVES:
I. Assess feasibility of enrolling and randomizing patients who are not local, and evaluate the quality of data received for those patients.
II. Assess whether prolonged IST decreases the need for pulses of high dose IST.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
- •Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone or prednisone continued for treatment of adrenal insufficiency is not considered a systemic IST
- •No evidence of malignancy at the time of enrollment
- •Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
- •Agreement to be contacted by phone or e-mail for health status evaluation for up to 3 years
- •Signed, informed consent
排除标准
- •Inability to comply with study procedures
结局指标
主要结局
Feasibility of Enrolling Patients
时间窗: 22.9 months
Descriptive summary of number of patients enrolled on the study (signed consent)
次要结局
- Incidence of Grade >= 3 Infections(Up to 12 months after randomization)
- Graft Versus Host Disease Manifestations(Up to 12 months after randomization)
- Enrollment Rate of Participants Who Are Not Local(Up to 12 months after randomization)
- Compliance With Treatment(Up to 12 months after randomization)
- Compliance With Data Collection(Up to 12 months after randomization)
- Quality of Data of Participants Who Are Not Local(Up to 12 months after randomization)
- Feasibility of Randomizing Patients(22.9 months)
- Recurrent Malignancy(Up to 12 months after randomization)
- Incidence of Grade >= 3 Organ Toxicity(Up to 12 months after randomization)
研究者
Stephanie Lee
Professor and Associate Director
Fred Hutchinson Cancer Center