A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 83
- 主要终点
- Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
研究概览
简要总结
The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.
详细描述
Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant is a CMV-seropositive HCT recipient
- •Participant is planned to undergo either of the following:
- •Sibling Donor Transplant
- •Unrelated Donor Transplant
- •Participant has one of the following underlying diseases:
- •Acute myeloid leukemia (AML)
- •Acute lymphoblastic leukemia (ALL)
- •Acute undifferentiated leukemia (AUL)
- •Acute biphenotypic leukemia
- •Chronic myelogenous leukemia (CML)
- •Chronic lymphocytic leukemia (CLL).
- •A defined myelodysplastic syndrome(s) (MDS)
- •Primary or secondary myelofibrosis
- •Lymphoma (including Hodgkin's)
排除标准
- •Participant has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
- •Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4
- •Participant has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
- •Participant who is scheduled to have a cord blood transplant or a haploidentical transplant
- •Participant has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed)
- •Participant has aplastic anemia or multiple myeloma
研究组 & 干预措施
ASP0113
Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
干预措施: ASP0113 (Biological)
Placebo
Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
时间窗: From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.
次要结局
- Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant(From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365))
- Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant(From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365))
- Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use(From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365))
- Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant(From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365))
- All-Cause Mortality at 1 Year Posttransplant(From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365))