Randomized Trial of Preemptive Treatment With Oral Valganciclovir Compared With IV Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant.
研究概览
简要总结
The purpose of this trial is to determine if preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing cytomegalovirus (CMV) viremia as determined by quantitative CMV polymerase chain reaction (PCR) assay in patients who have undergone bone marrow or peripheral blood stem cell transplant.
详细描述
- To study the effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.
- To determine the incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.
- To compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.
- To determine the toxicity profile of valganciclovir.
- To screen for mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment.
- To determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.
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
- 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
- •Patients receiving allogeneic peripheral blood stem cell transplant from either a related or unrelated donor at Washington University Medical Center.
- •An initial episode of CMV viremia.
- •At the time of randomization:
- •ANC greater than or equal to 1000
- •Age greater than or equal to 18
- •Adequate renal function with creatinine clearance greater than 10 ml/min
- •Total bilirubin less than or equal to 3.0
排除标准
- •Current GI graft versus host disease grade III-IV
- •Development of CMV disease prior to or at the time of the first detection of CMV viremia by PCR
- •Uncontrolled emesis or diarrhea (greater than or equal to 4 episodes per day) for 2 consecutive days
- •Pregnant or nursing female patient
- •Known hypersensitivity to ganciclovir
研究组 & 干预措施
Group A
IV ganciclovir (5mg/kg every 12 hours for 7 days followed by 5mg/kg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 5mg/kg every 24 hours for a total of 21 total days of therapy. If CMV viral load >5000/ml but less than index viral load after 14 days then 5mg/kg every 24 hours for a total of 28 total days of therapy. If CMV viral load >= index viral load after 14 days then 5mg/kg every 12 hours for 7 days. If repeat CMV viral load is <= the previous CMV viral load then 5mg/kg every 12 hours for an additional 7 days.
干预措施: Ganciclovir (Drug)
Group B
PO valganciclovir (900 mg every 12 hours for 7 days followed by 900 mg every 24 hours for 7 days. If CMV viral load <5000 copies/ml after 14 days then 900 mg every day until 21 total days of therapy. If CMV viral load >5000 copies/ml after 14 days but less than the index viral load then 900 mg every day until 28 total days of therapy. If CMV viral load >= the index viral load 900 mg every 12 hours for 7 days, if CMV viral load <= to previous viral load then 900 mg every 12 hours for another 7 days.
干预措施: Valganciclovir (Drug)
结局指标
主要结局
If preemptive therapy with oral valganciclovir is as effective as intravenous ganciclovir in clearing CMV viremia as determined by quantitative CMV PCR assay in patients who have undergone allogeneic bone marrow or peripheral stem cell transplant.
时间窗: 4 weeks from start of therapy
Clearance of CMV viremia will be defined as CMV viral load less than 5,000 copies/ml of whole blood.
次要结局
- Effect of preemptive therapy with IV ganciclovir and PO valganciclovir as determined by quantitative CMV PCR.(6 months)
- Incidence of CMV disease and CMV related mortality following preemptive treatment with oral valganciclovir and IV ganciclovir.(6 months)
- Compare the incidence of recurrent CMV viremia after treatment with PO valganciclovir to that seen after treatment with IV ganciclovir.(6 months)
- Toxicity profile of valganciclovir(6 months)
- Mutations in the UL97 gene in patients who have increasing CMV viral loads after 14 days of treatment(14 days)
- Determine if patients treated with PO valganciclovir have ganciclovir drug levels which are equivalent to those seen in historical control subjects treated with PO valganciclovir.(6 months)