Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AlloVir
- 入组人数
- 57
- 试验地点
- 47
- 主要终点
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
详细描述
During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergone allogeneic cell transplantation ≥21 days prior to dosing
- •Meet one of the below criteria:
- •AdV viremia DNA ≥10,000 copies/mL, OR
- •AdV viremia DNA results of ≥1,000 copies/mL, AND
- •has absolute lymphocyte count <180/mm3, OR
- •has received T cell depletion OR
- •had a cord blood transplant.
排除标准
- •Grade 3 or higher acute GVHD
- •Ongoing therapy with high-dose systemic corticosteroids
- •Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
- •Pregnant or lactating female unwilling to discontinue nursing prior to randomization
- •History of severe prior reactions to blood product transfusions
- •NOTE: Other protocol-defined inclusion/exclusion criterion may apply.
研究组 & 干预措施
Posoleucel + SoC
Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
干预措施: Posoleucel (Drug)
Placebo + SoC
Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 34 weeks
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Number of Participants With Undetectable Adenovirus Infection
时间窗: Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)
Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).
次要结局
- Area Under the Curve (AUC) Adenovirus Viral Load(Pre-dose and Day 29)
- Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29(Day 29)
- Number of Participants With Overall Disease Progression(From Day 29 up to Week 10)
- Time to Undetectable Adenovirus Viremia (Less Than LLOQ)(Pre-dose to 34 weeks)
- Number of Participants With Adenovirus Disease Recurrence(34 weeks)