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)
Trial status: Open for Enrollment
Why is this study being done?
The study will be divided into two parts. Part 1 of the study will include the first 100 subjects who are randomized. The purpose of Part 1 is to collect efficacy results to evaluate treatment effect on the primary endpoint and other efficacy endpoints to potentially modify the primary endpoint for being specified for Part 2 of the study.
Part 2 will include the subsequent 400 subjects to evaluate the vaccine efficacy on the incidence of the primary endpoint through one year post-transplant.
Who is eligible to participate?
- Subject is a CMV-seropositive HCT recipient
- Subject is planned to undergo either of the following:
- Sibling Donor Transplant
- Unrelated Donor Transplant
- 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).
- A defined myelodysplastic syndrome(s) (MDS)
- Primary or secondary myelofibrosis
- Lymphoma (including Hodgkin's)
- Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
- Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4
- Subject has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
- Subject who is scheduled to have a cord blood transplant or a haploidentical transplant
- Subject has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed)
- Subject has aplastic anemia or multiple myeloma