NCT01903928已完成2 期
An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests
研究概览
简要总结
This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is planned to undergo either of the following:
- •Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
- •Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
- •Subject 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) / myelodysplastic syndrome(s) (MDS)
- •Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders
排除标准
- •Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
- •Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
- •Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3
- •Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
- •Subject has received any of the following substances or treatments:
- •T-cell depletion of donor cell product.
- •Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
- •Administration of a CMV vaccine, including any prior exposure to ASP
- •Subject has received an allogeneic stem cell transplant within one year prior to transplant
- •Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy
- •Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.
研究组 & 干预措施
ASP0113 group
Experimental
Participants receive 1 mL of ASP0113 intramuscularly 5 times, on days -14 to -3, 14 to 40, 60 ± 5, 90 ± 10, and 180 ± 10, counting from the transplantation (stem cell transfusion) day (day 0)
干预措施: ASP0113 (Biological)
结局指标
主要结局
Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests
时间窗: for 365 days after HCT
次要结局
- Local reactogenicity(for 14 days following each injection)
- Incidence of CMV viremia(for 365 days after HCT)
- CMV-specified antiviral therapy(for 365 days after HCT)
- Incidence of cytomegalovirus end-organ disease (CMV EOD)(for 365 days after HCT)
- Maximum grade of Graft Versus Host Disease (GVHD)(for 365 days after HCT)
研究者
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