NCT00016068已完成3 期
A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 7
- 主要终点
- Late cytomegalovirus infection by plasma PCR positivity
研究概览
简要总结
RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.
PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.
详细描述
OBJECTIVES:
Primary
- Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.
- Compare the incidence of CMV disease in patients treated with these drugs.
- Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.
Secondary
- Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs.
- Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.
- Determine the safety of valganciclovir in these patients.
- Compare the quality of life of patients treated with these drugs.
- Compare CMV-specific immune reconstitution in patients treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Have undergone allogeneic peripheral blood stem cell, cord blood, or marrow transplantation (related or unrelated, T-cell depleted or non-T-cell depleted, CD34-selected or non-selected, or myeloablative or non-myeloablative) within the past 80-120 days
- •Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor
- •Seropositive recipients with one of the following:
- •CMV infection before day 80, as determined by:
- •pp65 antigenemia
- •CMV DNA in plasma
- •Peripheral blood leukocytes (PBL) or whole blood at any level detected by polymerase chain reaction or hybrid capture
- •CMV pp67 mRNA
- •CMV viremia by blood culture
- •Surveillance bronchoalveolar lavage (culture or cytology)
- •CMV disease more than 6 weeks prior to enrollment
- •Presence of graft-versus-host disease (GVHD) at enrollment
- •Acute GVHD that requires treatment with systemic corticosteroids of doses greater than 0.5 mg/kg OR
- •Chronic clinically extensive GVHD requiring treatment with corticosteroids
- •Continuous prophylaxis with ganciclovir, foscarnet, or cidofovir between engraftment and day 80 OR
- •Seronegative recipient with seropositive donor who has CMV infection before day 80
- •No rising or uncontrolled CMV load (pp65 antigenemia levels no greater than 1/slide or no greater than 100 copies of CMV DNA per mL of plasma or per million PBL allowed)
- •No CMV disease within 6 weeks prior to randomization
- •No leukemic relapse
- •Cytogenetic or molecular relapse allowed
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 2 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm^3 for at least 1 week prior to enrollment
- •Not specified
- •Creatinine no greater than 2.5 mg/mL
- •No hypersensitivity to ganciclovir or valganciclovir
- •No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 90 days after study participation
- •HIV negative
- •Proficient in English
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •Not specified
- •Not specified
- •Prior ganciclovir, foscarnet, cidofovir, high-dose acyclovir, or valacyclovir as prophylaxis or preemptive therapy allowed
- •No concurrent prophylactic foscarnet, cidofovir, or ganciclovir (IV or oral)
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Late cytomegalovirus infection by plasma PCR positivity
次要结局
未报告次要终点
研究者
研究点 (7)
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