Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AlloVir
- 入组人数
- 97
- 试验地点
- 91
- 主要终点
- Time to Resolution of Macroscopic Hematuria
研究概览
简要总结
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
详细描述
The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population).
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
- 1 Year 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
结局指标
主要结局
Time to Resolution of Macroscopic Hematuria
时间窗: Up to 24 weeks
Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.
次要结局
- Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)(Up to 24 weeks)
- Average Daily Bladder Pain(Until event occurrence through Week 6)
- Time Until Bladder Pain is Resolved(Until event occurrence through Week 24)
- Days in the Hospital for Any Reason(Until event occurrence through Week 24)
- Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)(Up to 24 weeks)
- Time to Resolution for All Target Viruses(Until event occurrence through Week 24)